Aknof - Clinical Study, Botanical / Acne

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Information about Aknof - Clinical Study, Botanical / Acne

Published on August 9, 2007

Author: DermaVista

Source: slideshare.net

Rif volontario: 01 Tempo t0 A B A B C D C D A-B-C-D Cute papulo comedonica pustolosa infiammata presenta una quantità notevole di sebo

Rif volontario: 01 Tempo t60 A B A B C D c D A-B-C-D A t=60 giorni non si evidenziano stati infiammatori .

Rif volontario: 02 Tempo t0 C A B B A C D D A-B-C-D Cute papulo comedonica infiammata.

Rif volontario: 02 Tempo t60 C A B B A D c D A-B-C-D Dopo l’uso del Prodotto si evidenzia un significativo miglioramento della cute.

Rif volontario: 02 Tempo t0 C A B B A C D D A-B-C-D Cute papulo comedonica infiammata.

Rif volontario: 02 Tempo t60 C A B B A D c D A-B-C-D Dopo l’uso del Prodotto si evidenzia un significativo miglioramento della cute.

Rif volontario: 03 Tempo t0 B D C A A B C D A-B-C-D Cute comedonica infiammata con presenza di elevata seborrea.

Rif volontario: 03 Tempo t60 B D C A A B c D A-B-C-D Dopo l’uso del Prodotto la cute presenta un minor numero di comedoni

Rif volontario: 04 Tempo t0 B A B A C D C D A-B-C-D Cute con presenza di papule-pustole infiammate.

Rif volontario: 04 Tempo t60 B A B A C D C D A-B-C-D Non si rilevano nuove papule-pustole.

Rif volontario: 05 Tempo t0 B A A B C C D D A-B-C-D Cute con acne papulocomedonica.

Rif volontario: 05 Tempo t60 B A A B C C D D A-B-C-D Dopo il trattamento si nota un netto miglioramento .

Rif volontario: 06 Tempo t0 B A B C C A A-B-C Cute con acne papulosa.

Rif volontario: 06 Tempo t60 B A B C C A A-B-C Dopo l’uso del Prodotto si evidenzia un significativo miglioramento della cute.

Rif volontario: 07 Tempo t0 A B B C C A A-B-C Cute papulo comedonica pustolosa infiammata presenta una quantità notevole di sebo

Rif volontario: 07 Tempo t60 A B B C C A A-B-C A t=60 giorni si evidenzia ancora un lieve stato infiammatorio .

Rif volontario: 08 Tempo t0 A B C A B C D D A-B-C-D Papule evidenti.

Rif volontario: 08 Tempo t60 A B C A B C D D A-B-C-D Si nota un significativo miglioramento dopo il trattamento.

Dott. Fulvio MARZATICO Ricerca - Sviluppo - Valutazione SEZIONE DI FARMACOLOGIA E Documentazione Dermo-cosmetologica BIOTECNOLOGIE FARMACOLOGICHE UNIVERSITA’ DEGLI STUDI DI PAVIA Via Antonio Panizzi, 10 Piazza Botta 11 - 27100 PAVIA (Italy) DIPARTIMENTO DI SCIENZE 20146 Milano (Italy) Tel. (39) 0382 - 506390 - Fax: 506385 FISIOLOGICHE-FARMACOLOGICHE Tel.(039 2) 4155729 tel/fax (039 2) 4150184 e-mail: fulviomk@unipv.it CELLULARI - MOLECOLARI. Valutazione dell'efficacia di un prodotto cosmetico coadiuvante il trattamento dell'acne mediante test clinico Clinical evaluation of the efficacy of a cosmetic product in the treatment of acne Protocollo n°/ Record no. 0302A08F AKNOF Luogo e data di emissione: MILANO – 14 Aprile 2003 Place and date of issue: MILAN – 14th April 2003

Protocollo n°/ Record no. 0302A08F AKNOF PARTE SPERIMENTALE Experimental part Protocollo n° / Record no. 0302A08F Titolo / Title Clinical evaluation of the efficacy of a cosmetic product in the treatment of acne. Scopo / Aim The objective of this clinical test is to evaluate if the tested cosmetic product is effective in the treatment of acne. Controllo Qualità / Quality Control Dr. Claudio ANGELINETTA, laurea in Chimica presso l’Università degli Studi di Milano - specializzato in Scienza e Tecnologia Cosmetiche presso l’Università degli Studi di Milano - Direttore tecnico BIO BASIC EUROPE S.r.l. Via Antonio Panizzi, 10 - 20146 Milano Tel 02 4155729 Fax 02 4150184 Monitor Prof. Dott. Fulvio MARZATICO UNIVERSITA' di PAVIA Dip. Scienze Fisiologiche - Farmacologiche - Cellulari - Molecolari Sezione di Farmacologia e Biotecnologie Farmaceutiche. Piazza Botta, 11 - 27100 PAVIA Tel. (0382) 506.390 Fax (0382) 506.390 Sperimentatore / Experimenter Dott. Carlo CARRERA Medico Chirurgo- Specialista in Dermatologia e Venereologia consulente C.D.C. - Via A. Panizzi, 10 - 20146 MILANO Tel 02/4155729 Fax 02/4150184 18 Pag. 2 di 18 / page 2 out of

Protocollo n°/ Record no. 0302A08F AKNOF Soggetti del test / Test subjects 30 subjects with acne, both males and females, with an age between 18 and 28 years of age, have been selected for the test, following the undermentioned inclusion criteria: - good state of general health - no dermatopathies - no pharmacological treatment in progress - promise not to change the usual daily routine - no atopy in the anamnesis Preparazione dei campioni / Preparation of the samples Samples of the products have been applied following their usual use: as they are. Metodo di applicazione dei campioni / Method of application of the samples Samples of the product have been applied on clean face, following the instructions reported in the form given to the volunteer. Application was uniform. Valutazione e calcolo dei risultati / Evaluation and reckoning of the results The sebum, moisturizing* and TEWL** differences are evaluated by analysing the values taken on the face before and after the product’s application by using the Sebometer (SKINLAB®), the Corneometer * (SKINLAB®) and the Tewameter®. The measurements are taken: at [t0] (basal value) • after the product use:after15 days [t15], 30 [t30] and 60 [t60]. • The sebometric, moisturizing and TEWL measurements are taken by the experimenter in the medical institute and then, are analysed and reported in a graph. *Skin moisturising has been evaluated by instrumental measurements with a Corneometer. Corneometry is an indirect model of skin hydration measurements, since it is based on the electric conduction of the skin in presence of water. Biological tissues and skin conductance vary according to their water content. **The Tewameter indicates the transepidermal water loss (TEWL), in terms of quantity of evaporated water for the considered skin unit. The method measures the gradient of steam tension between two electrodes located at different distances from the skin surface. The method allows evaluating integrity of the corneal layer, functionality of the skin barrier. The shift of TEWL values from high levels to normal levels, in subjects with altered skin barrier functionality indicates an increase of hydration, while an increase of TEWL values from normal values to high levels indicates a damage of the barrier functionality of the skin. A series of skin pictures are taken by a polarized light telecamera with 20x magnifications. 18 Pag. 3 di 18 / page 3 out of

Protocollo n°/ Record no. 0302A08F AKNOF Finally, to carry out a statistical survey and to be able to evaluate the skin variations in a specific period of time, the following skin parameters have been analyzed: Variazione dello stato infiammatorio delle papule/pustole Variation of the inflammation of papules/pustules Nessuna variazione rispetto all'inizio della sperimentazione Nessuna No variation (in comparison with the Absent beginning of the experimentation) Leggera variazione rispetto all'inizio della sperimentazione Leggera Slight variation (in comparison with the Slight beginning of the experimentation) Discreta variazione rispetto all'inizio della sperimentazione Discreta Fairly good variation (in comparison with Fairly good the beginning of the experimentation) Variazione significativa rispetto all'inizio della sperimentazione Buona Good variation(in comparison with the Good beginning of the experimentation) 18 Pag. 4 di 18 / page 4 out of

Protocollo n°/ Record no. 0302A08F AKNOF TABELLA RIASSUNTIVA DEI SINGOLI DATI Summarizing Table of the Values found out Idratazione cutanea Values taken with the corneometer after the prolonged use of the product Rif. Volontario t0 t15 t30 t60 Ref. Volunteer 0 15 30 60 01SM 38,2 39 36,1 38,9 02DML 44,3 52,4 39,5 40,5 03AAM 30,5 33,1 34 36,2 04MA 38,7 39 39,9 40,3 Idratazione cutanea 05PG 35,3 39,1 37,9 39,9 Values taken w ith the corneom eter 06GM 34,5 35,4 36,3 40 07FR 32,9 35 35,5 38,1 08VMT 34,9 39,1 38 45 09SS 32,5 33,6 34 38,3 40,00 10PE 40,2 40,8 41 45 11SG 36,7 38 39,1 40,3 12AE 35,9 36,1 38 38,2 38,00 13GV 37 38,9 39,7 40 14BS 34,5 35,2 35,6 36,2 15LL 38,6 39 39,5 40,6 16LLAI 39,1 42,8 42,8 43,4 36,00 17AA 35,1 35,3 35,6 36,6 18RR 34,2 35,9 36 37 19RD 30,2 32,2 33 35,7 20GG 36 36,6 37 38 34,00 t0 t15 t30 t60 21ZI 35,4 36,7 36,7 38 35,39 37,29 37,22 38,79 Media/Average 22RG 36,6 37,1 38,1 38 23PN 33 34 34,1 34,6 24BE 37,8 38 37,5 39,5 25DFP 32,1 33,4 34,6 35,5 26CG 29 39,9 40 40 27CA 32,4 33,6 34,7 35,6 28GF 36,6 37 38,8 39 29RCP 35,5 36 37 37,2 30UM 34 36,6 36,6 38 Media 35,39 37,29 37,22 38,79 Average Dev. STD 3,1954008 3,7918182 2,3451197 2,5659217 sign 99% Test t (val. est. Student +- 2,7) 2,0670362 2,4863348 4,4634212 NO NO SI/yes 18 Pag. 5 di 18 / page 5 out of

Protocollo n°/ Record no. 0302A08F AKNOF Variazione TEWL TEWL variation Rif. Volontario t0 t15 t30 t60 Ref. Volunteer 0 7 15 01SM 19,0 18,2 18,0 7,3 02DML 11,0 9,3 9,6 7,1 03AAM 24,3 24,2 22,2 18,9 04MA 27,0 19,5 15,8 13,6 05PG 14,1 10,0 9,9 6,9 06GM 18,0 16,3 16,5 15,9 Variazione TEWL 07FR 20,3 17,6 16,6 10,0 TEWL variation 08VMT 21,0 19,0 16,2 14,4 09SS 11,6 11,0 10,0 6,0 10PE 18,0 17,6 15,8 12,1 18 11SG 16,9 16,0 12,4 9,6 12AE 17,9 13,1 12,1 9,0 16 13GV 11,6 11,2 8,6 8,0 14BS 15,8 13,3 12,3 8,0 14 15LL 19,0 14,5 14,0 10,0 16LLAI 17,2 15,6 15,3 10,3 12 17AA 17,8 16,6 16,1 14,0 10 18RR 19,0 18,9 17,4 14,4 19RD 20,2 18,3 14,0 13,0 8 20GG 11,3 9,4 9,0 6,1 t0 t15 t30 t60 21ZI 9,0 8,7 8,0 7,0 16,6 14,9 13,7 11,1 Media/Average 22RG 16,0 15,8 14,0 13,3 23PN 19,0 18,0 18,5 17,0 24BE 16,5 15,4 15,0 14,3 25DFP 12,2 11,9 9,8 9,0 26CG 14,7 12,3 11,9 10,4 27CA 8,5 7,7 6,6 5,9 28GF 11,0 10,2 9,9 8,0 29RCP 20,0 18,4 17,0 16,6 30UM 19,0 18,0 18,0 16,6 Media 16,6 14,9 13,7 11,1 Average Dev. STD 4,3774094 4,0049395 3,7759752 3,8133477 sign 99% Test t (val. est. student -1,539985 -2,682812 -5,077085 +-2,7) NO NO SI/yes 18 Pag. 6 di 18 / page 6 out of

Protocollo n°/ Record no. 0302A08F AKNOF Presenza di sebo Presence of sebum Rif. Vol Vol.Ref. t0 t15 t30 t60 0 30 01SM 26 24 22 16 Valori sebometrici /Sebum values 02DML 22 18 18 15 Pelle secca /Dry skin 1-10 03AAM 28 27 26 26 Pelle normale/ Normal skin 11-25 04MA 22 20 16 13 Pelle grassa/ Oily skin 26-100 05PG 12 12 11 6 06GM 27 25 24 23 07FR 16 14 12 10 08VMT 24 20 22 11 09SS 20 18 17 14 10PE 9 9 8 6 11SG 28 28 26 24 12AE 16 7 6 4 13GV 15 13 12 9 14BS 16 15 14 12 Presenza di sebo 15LL 13 11 11 9 Presence of sebum 16LLAI 28 27 24 20 17AA 14 12 11 8 18RR 10 9 6 8 20 19RD 28 27 28 24 18 20GG 16 14 14 11 21ZI 14 12 11 11 16 22RG 15 13 12 9 14 23PN 28 27 25 24 12 24BE 10 9 8 7 25DFP 16 15 10 10 10 26CG 29 28 26 25 8 27CA 25 23 22 21 t0 t15 t30 t60 28GF 26 25 24 23 19,17 17,40 16,10 13,70 Media/Average 29RCP 12 11 10 7 30UM 10 9 7 5 Media Average 19,17 17,40 16,10 13,70 Dev. STD 6,823304 7,025078 7,111671 7,027777 sign 99% Test t -0,97146 -1,67564 -3,00542 (val. est. Student no no SI/yes ±2,7) 18 Pag. 7 di 18 / page 7 out of

Protocollo n°/ Record no. 0302A08F AKNOF Variazione dello stato infiammatorio delle papule/pustole Variation of the inflammation of papulae/pustules Rif. t0 t15 t30 t60 Volontario 0 Nessuna/Absent Nessuna/Absent Nessuna/Absent 01SM // Nessuna/Absent Nessuna/Absent Leggera/Slight 02DML // Nessuna/Absent Leggera/Slight Leggera/Slight 03AAM // Leggera/Slight Leggera/Slight Leggera/Slight 04MA // Leggera/Slight Discreta/Fairly good Discreta/Fairly good 05PG // Nessuna/Absent Leggera/Slight Leggera/Slight 06GM // Nessuna/Absent Nessuna/Absent Leggera/Slight 07FR // Leggera/Slight Discreta/Fairly good Discreta/Fairly good 08VMT // Leggera/Slight Leggera/Slight Leggera/Slight 09SS // Nessuna/Absent Nessuna/Absent Nessuna/Absent 10PE // Leggera/Slight Leggera/Slight Leggera/Slight 11SG // Leggera/Slight Leggera/Slight Discreta/Fairly good 12AE // Leggera/Slight Leggera/Slight Leggera/Slight 13GV // Nessuna/Absent Leggera/Slight Leggera/Slight 14BS // Nessuna/Absent Nessuna/Absent Nessuna/Absent 15LL // Nessuna/Absent Nessuna/Absent Leggera/Slight 16LLAI // Leggera/Slight Leggera/Slight Discreta/Fairly good 17AA // Nessuna/Absent Leggera/Slight Leggera/Slight 18RR // Nessuna/Absent Leggera/Slight Leggera/Slight 19RD // Leggera/Slight Nessuna/Absent Nessuna/Absent 20GG // Leggera/Slight Leggera/Slight Discreta/Fairly good 21ZI // Leggera/Slight Leggera/Slight Leggera/Slight 22RG // Nessuna/Absent Leggera/Slight Leggera/Slight 23PN // Leggera/Slight Leggera/Slight Leggera/Slight 24BE // Nessuna/Absent Nessuna/Absent Nessuna/Absent 25DFP // Nessuna/Absent Leggera/Slight Leggera/Slight 26CG // Nessuna/Absent Leggera/Slight Leggera/Slight 27CA // Leggera/Slight Nessuna/Absent Nessuna/Absent 28GF // Nessuna/Absent Nessuna/Absent Nessuna/Absent 29RCP // Leggera/Slight Leggera/Slight Leggera/Slight 30UM // STATISTICAL ANALISYS The Friedman Test allows the statical analisys of non parametric data. (Cosmetic news, 130, January/February (30-32). A score between 1-4 is given to the experimenter evaluations (Variation: Absent, Slight,Fairly good, Good).(t0=1). For each period average values are calculated. The test is significant if the average differences are bigger than the threshold value (Interval Confidence 95%) ANALISI STATISTICA Per la valutazione statistica di dati non parametrici (scores) non indipendenti si è utilizzato il Test di Friedman (Cosmetic news, 130, January/February (30-32)). Ad ogni giudizio dello sperimentatore (Variazione: Nessuna, Leggera, Discreta, Buona) viene assegnato un punteggio da 1 a 4.(t0=1). Per ogni intervallo di tempo si sommano i punteggi attribuiti ad ogni singolo volontario e si calcolano le relative medie. A questo punto si valutano le differenze tra le diverse medie. Le variazioni tra le medie risultano essere significative se superano il valore soglia definito (Intervallo di confidenza 95%). 18 Pag. 8 di 18 / page 8 out of

Protocollo n°/ Record no. 0302A08F AKNOF Variazione dello stato infiammatorio delle papule/pustole Variation of the inflammation of papulae/pustules 3 2 1 t0 t15 t30 t60 1 1,47 1,73 1,93 Media / Average Criteri di valutazione: Evaluation criteria: Nessuna (absent) = 1; Leggera (slight) = 2; Discreta (fairly good) = 3; Buona (good) = 4. Test di |t15-t0| |t30-t0| [t60-t0] Friedman sign. 95% 0,47 0,73 0,93 per val > NO NO SI/yes 0,879333 Serie1 Serie2 1 0,9 0,8 0,7 0,6 0,5 0,4 0,3 0,2 0,1 0 |t15-t0| |t30-t0| [t60-t0] 18 Pag. 9 di 18 / page 9 out of

Protocollo n°/ Record no. 0302A08F AKNOF CONCLUSIONI Conclusions Come si può osservare il prodotto denominato As one can notice the product called AKNOF é in grado di modificare in maniera significativa, nel periodo di trattamento, i parametri clinici valutati nei volontari sottoposti a test. can significantly change in the period of treatment the clinical parameters evaluated on the volunteers who underwent the clinical test. In base ai risultati: According to the results: IL PRODOTTO COADIUVA LA RIDUZIONE DEGLI INESTETISMI CUTANEI DERIVANTI DALL’ACNE This product is effective in reducing cutaneous imperfections due to acne Sperimentatore / Experimenter Monitor Dott. Carlo CARRERA Prof. Fulvio MARZATICO Controllo Qualità / Quality Control Dr. Claudio Angelinetta 18 Pag. 10 di 18 / page 10 out of

Protocollo n°/ Record no. 0302A08F AKNOF Allegato A: arruolamento / Enclosure A : recruitment Data (gg.mm.aa) / Date (d/m/y) : Volontario n° / Volunteer no.: MODULO DI CONSENSO INFORMATO / Consent Form Iniziali del volontario / Volunteer’s initials Titolo / Title Valutazione dell'efficacia di un prodotto cosmetico coadiuvante il trattamento dell'acne mediante test clinico. Clinical evaluation of the efficacy of a cosmetic product in the treatment of acne. Metodo di applicazione dei campioni / Method of application of the samples I campioni sono stati testati applicandoli in modo uniforme sul viso, secondo le indicazioni riportate nella scheda descrittiva consegnata al volontario. Samples of the products have been applied on the face, following the instructions reported in the form given to the volunteer. Application was uniform. Protocollo n° / Record no. 0302A08F Confermo che il volontario ha letto la scheda informativa allegata a questo protocollo. Al volontario è stata data l'opportunità di porre domande ed a queste domande è stata data risposta esauriente, è stato spiegato lo scopo, le modalità e le caratteristiche dello studio clinico, gli effetti favorevoli ed i possibili effetti collaterali. Il volontario ha accettato spontaneamente di partecipare allo studio. I confirm that the volunteer has read the enclosed informative form. The volunteer has had the opportunity to ask questions to which was given an exhaustive answer. The volunteer was explained the aim, the method and the features of the clinical survey, benefits and possible discomforts. The volunteer has agreed to take part in the test. Data / Date : Nome del medico / Physician’s name (in stampatello) / (in block letters) _________________________________________ Firma del medico / Physician’s signature _________________________________________ 18 Pag. 11 di 18 / page 11 out of

Protocollo n°/ Record no. 0302A08F AKNOF Allegato B: arruolamento / Enclosure B : recruitment Data (gg.mm.aa) / Date (d/m/y) : Volontario n° / Volunteer no. : VERIFICA DEI CRITERI DI INCLUSIONE ED ESCLUSIONE Check of the inclusion and exclusion criteria Iniziali del volontario / Volunteer’s initials L'età è di almeno 18 anni e non ancora 70 anni SI NO Age: between 18 and 70 years YES Buono stato di salute generale SI NO Good state of general health YES Assenza di patologie cutanee SI NO Absence of dermatopathies YES Assenza di trattamenti farmacologici in atto SI NO Absence of pharmacological treatment in progress YES Impegno a non variare dalla normale routine la loro quotidiana attività SI NO Promise not to change the usual daily routine YES Anamnesi negativa per atopia SI NO No atopy in the anamnesis YES E' stato ottenuto il consenso informato secondo le procedure indicate in protocollo SI NO In compliance with the procedures mentioned in the survey the volunteer, after having been YES informed, has given his or her consent ATTENZIONE: Un solo segno nella colonna di destra è motivo sufficiente per NON arruolare il volontario nello studio ATTENTION: Just one mark only indicating “no” is enough to exclude the volunteer from the survey 18 Pag. 12 di 18 / page 12 out of

Protocollo n°/ Record no. 0302A08F AKNOF Allegato C: arruolamento / Enclosure C : recruitment Data (gg.mm.aa) / Date (d/m/y) : Volontario n° / Volunteer no. : SCHEDA INFORMATIVA / Informative form Iniziali del volontario / Volunteer’s initials Titolo / Title Valutazione dell'efficacia di un prodotto cosmetico coadiuvante il trattamento dell'acne mediante test clinico. Clinical evaluation of the efficacy of a cosmetic product in the treatment of acne. Metodo di applicazione dei campioni / Method of application of the samples I campioni sono stati testati applicandoli in modo uniforme sul viso, secondo le indicazioni riportate nella scheda descrittiva consegnata al volontario. Samples of the products have been applied on the face, following the instructions reported in the form given to the volunteer. Application was uniform. Protocollo n° / Record no. 0302A08F Premessa / Introduction: Tutti i prodotti cosmetici sottoposti a test sono formulati utilizzando nessuna sostanza di cui è proibito l'uso in prodotti cosmetici e di igiene corporale (legislazione CEE), che gli agenti conservanti introdotti nella formula del prodotto, figurano nella lista positiva pubblicata dalla CEE e sono utilizzati ad una concentrazione conforme all'uso previsto da questa legge ed inoltre tutte le sostanze di cui c'è un limite di concentrazione, vengono segnalati i limiti e le avvertenze riportati nei vari allegati nella Normativa CEE 76/768. All tested cosmetic products do not contain any substance which is forbidden by the EEC legislation as far as the use of cosmetic and personal hygiene products is concerned, the preservatives in the product formula are in the list of accepted components published by the EEC and are used in a concentration provided for by the law and moreover limits and instructions, published in the Enclosures of the 76/768 EEC regulation, are mentioned for those substances for which there is a concentration limit. Scopo / Aim Tale test consente di valutare se il prodotto cosmetico sottoposto a test abbia efficacia nel coadiuvare il trattamento dell’acne. The objective of this clinical test is to evaluate if the tested cosmetic product is effective in the treatment of acne. 18 Pag. 13 di 18 / page 13 out of

Protocollo n°/ Record no. 0302A08F AKNOF SCHEDA INFORMATIVA (cont.) / Informative Form (Continuation) Confidenzialità dei dati clinici / The clinical data are strictly confidential E' possibile che durante o al termine dello studio, funzionari della Società che ha promosso lo studio o funzionari delle Autorità Sanitarie debbano esaminare la sua cartella clinica. Questi risultati potranno anche essere pubblicati. In ogni caso Lei non sarà mai indicato per nome se non assolutamente necessario e che anche in questo caso solo a persone soggette, come noi, al segreto professionale. Tutte le informazioni che saranno raccolte in questo studio resteranno comunque del tutto confidenziali e Lei non potrà essere identificato da queste informazioni. During or at the end of the test the promoters of the survey or some Health officers may have to examine your case file. The results could also be published. In any case your name will never be mentioned, unless if absolutely necessary and also in this case only to people - who like us - are subject to professional secrecy. All information gathered in the survey will remain strictly confidential and you will not be identified from it. Cosa succederà se lei dovesse decidere di non partecipare allo studio? / What happens, if you decide not to take part in the test ? La Sua decisione di prendere parte a questo studio deve essere assolutamente volontaria, non deve sentirsi in nessun modo obbligato a partecipare. Se Lei decidesse di non partecipare allo studio non andrà incontro a nessun inconveniente né perderà alcuno dei benefici che le sono oggi garantiti. Se Lei dovesse interrompere il trattamento in qualunque momento durante lo studio, oltre a non andare incontro a nessun inconveniente né perdere alcuno dei benefici che le sono oggi garantiti. Tuttavia, in caso di interruzione dello studio, è molto importante che ne informi rapidamente il suo medico e che cerchi comunque di tornare per una visita di controllo. Anche noi ci riserviamo comunque di poter sospendere il trattamento qualora notassimo che non sia più giustificato come il migliore a cui Lei ha diritto. Your decision to take part in the test must be absolutely voluntary, you must not feel forced to. If you decide not to take part, you will neither run into any inconvenience nor lose any benefit which you enjoy at present. If you decide to interrupt the treatment, you can do it any time and you will neither run into any inconvenience nor lose any benefit you enjoy now. However, if you decide to interrupt it, you should inform your physician promptly and you should better come back for a check up. We ourselves reserve the right to interrupt the test if we feel it isn’t any longer good for you. Lei ha il diritto di rivolgere tutte le domande e tutte le richieste di chiarimento che ritiene opportune, sia ora che in qualunque momento in seguito, rivolgendosi direttamente a: You can ask questions or you can ask for an explanation any time before, during and after the treatment applying directly to: Dott. / Physician __________________________ Telefono / Phone _______________ che la seguirà per tutta la durata dello studio who will attend you throughout the treatment. 18 Pag. 14 di 18 / page 14 out of

Protocollo n°/ Record no. 0302A08F AKNOF Enclosure E: Helsinki Declaration DECLARATION OF HELSINKI Ethical Principles for Medical Research Involving Human Subjects Adopted by the 18th WMA General Assembly Helsinki, Finland, June 1964 and amended by the 29th WMA General Assembly, Tokyo, Japan, October 1975, 35th WMA General Assembly, Venice, Italy, October 1983, 41st WMA General Assembly, Hong Kong, September 1989, 48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996, 52nd WMA General Assembly, Edinburgh, Scotland, October 2000. A. Introduction 1. The World Medical Association has developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. Medical research involving human subjects includes research on identifiable human material or identifiable data. 2. It is the duty of the physician to promote and safeguard the health of the people. The physician's knowledge and conscience are dedicated to the fulfilment of this duty. 3. The Declaration of Geneva of the World Medical Association binds the physician with the words, quot;The health of my patient will be my first consideration,quot; and the International Code of Medical Ethics declares that, quot;A physician shall act only in the patient's interest when providing medical care which might have the effect of weakening the physical and mental condition of the patient.quot; 4. Medical progress is based on research which ultimately must rest in part on experimentation involving human subjects. 5. In medical research on human subjects, considerations related to the well-being of the human subject should take precedence over the interests of science and society. 6. The primary purpose of medical research involving human subjects is to improve prophylactic, diagnostic and therapeutic procedures and the understanding of the aetiology and pathogenesis of disease. Even the best proven prophylactic, diagnostic, and therapeutic methods must continuously be challenged through research for their effectiveness, efficiency, accessibility and quality. 7. In current medical practice and in medical research, most prophylactic, diagnostic and therapeutic procedures involve risks and burdens. 8. Medical research is subject to ethical standards that promote respect for all human beings and protect their health and rights. Some research populations are vulnerable and need special protection. The particular needs of the economically and medically disadvantaged must be recognized. Special attention is also required for those who cannot give or refuse consent for themselves, for those who may be subject to giving consent under duress, for those who will not benefit personally from the research and for those for whom the research is combined with care. 18 Pag. 15 di 18 / page 15 out of

Protocollo n°/ Record no. 0302A08F AKNOF 9. Research Investigators should be aware of the ethical, legal and regulatory requirements for research on human subjects in their own countries as well as applicable international requirements. No national ethical, legal or regulatory requirement should be allowed to reduce or eliminate any of the protections for human subjects set forth in this Declaration. B. Basic Principles For All Medical Research 10. It is the duty of the physician in medical research to protect the life, health, privacy, and dignity of the human subject. 11. Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and on adequate laboratory and, where appropriate, animal experimentation. 12. Appropriate caution must be exercised in the conduct of research which may affect the environment, and the welfare of animals used for research must be respected. 13. The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol. This protocol should be submitted for consideration, comment, guidance, and where appropriate, approval to a specially appointed ethical review committee, which must be independent of the investigator, the sponsor or any other kind of undue influence. This independent committee should be in conformity with the laws and regulations of the country in which the research experiment is performed. The committee has the right to monitor ongoing trials. The researcher has the obligation to provide monitoring information to the committee, especially any serious adverse events. The researcher should also submit to the committee, for review, information regarding funding, sponsors, institutional affiliations, other potential conflicts of interest and incentives for subjects. 14. The research protocol should always contain a statement of the ethical considerations involved and should indicate that there is compliance with the principles enunciated in this Declaration. 15. Medical research involving human subjects should be conducted only by scientifically qualified persons and under the supervision of a clinically competent medical person. The responsibility for the human subject must always rest with a medically qualified person and never rest on the subject of the research, even though the subject has given consent. 16. Every medical research project involving human subjects should be preceded by careful assessment of predictable risks and burdens in comparison with foreseeable benefits to the subject or to others. This does not preclude the participation of healthy volunteers in medical research. The design of all studies should be publicly available. 17. Physicians should abstain from engaging in research projects involving human subjects unless they are confident that the risks involved have been adequately assessed and can be satisfactorily managed. Physicians should cease any investigation if the risks are found to outweigh the potential benefits or if there is conclusive proof of positive and beneficial results. 18. Medical research involving human subjects should only be conducted if the importance of the objective outweighs the inherent risks and burdens to the subject. This is especially important when the human subjects are healthy volunteers. 18 Pag. 16 di 18 / page 16 out of

Protocollo n°/ Record no. 0302A08F AKNOF 19. Medical research is only justified if there is a reasonable likelihood that the populations in which the research is carried out stand to benefit from the results of the research. 20. The subjects must be volunteers and informed participants in the research project. 21. The right of research subjects to safeguard their integrity must always be respected. Every precaution should be taken to respect the privacy of the subject, the confidentiality of the patient's information and to minimize the impact of the study on the subject's physical and mental integrity and on the personality of the subject. 22. In any research on human beings, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail. The subject should be informed of the right to abstain from participation in the study or to withdraw consent to participate at any time without reprisal. After ensuring that the subject has understood the information, the physician should then obtain the subject's freely-given informed consent, preferably in writing. If the consent cannot be obtained in writing, the non-written consent must be formally documented and witnessed. 23. When obtaining informed consent for the research project the physician should be particularly cautious if the subject is in a dependent relationship with the physician or may consent under duress. In that case the informed consent should be obtained by a well-informed physician who is not engaged in the investigation and who is completely independent of this relationship. 24. For a research subject who is legally incompetent, physically or mentally incapable of giving consent or is a legally incompetent minor, the investigator must obtain informed consent from the legally authorized representative in accordance with applicable law. These groups should not be included in research unless the research is necessary to promote the health of the population represented and this research cannot instead be performed on legally competent persons. 25. When a subject deemed legally incompetent, such as a minor child, is able to give assent to decisions about participation in research, the investigator must obtain that assent in addition to the consent of the legally authorized representative. 26. Research on individuals from whom it is not possible to obtain consent, including proxy or advance consent, should be done only if the physical/mental condition that prevents obtaining informed consent is a necessary characteristic of the research population. The specific reasons for involving research subjects with a condition that renders them unable to give informed consent should be stated in the experimental protocol for consideration and approval of the review committee. The protocol should state that consent to remain in the research should be obtained as soon as possible from the individual or a legally authorized surrogate. 27. Both authors and publishers have ethical obligations. In publication of the results of research, the investigators are obliged to preserve the accuracy of the results. Negative as well as positive results should be published or otherwise publicly available. Sources of funding, institutional affiliations and any possible conflicts of interest should be declared in the publication. Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication. 18 Pag. 17 di 18 / page 17 out of

Protocollo n°/ Record no. 0302A08F AKNOF C. Additional principles for medical research combined with medical care 28. The physician may combine medical research with medical care, only to the extent that the research is justified by its potential prophylactic, diagnostic or therapeutic value. When medical research is combined with medical care, additional standards apply to protect the patients who are research subjects. 29. The benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods. This does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic or therapeutic method exists. 30. At the conclusion of the study, every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods identified by the study. 31. The physician should fully inform the patient which aspects of the care are related to the research. The refusal of a patient to participate in a study must never interfere with the patient-physician relationship. 32. In the treatment of a patient, where proven prophylactic, diagnostic and therapeutic methods do not exist or have been ineffective, the physician, with informed consent from the patient, must be free to use unproven or new prophylactic, diagnostic and therapeutic measures, if in the physician's judgement it offers hope of saving life, re-establishing health or alleviating suffering. Where possible, these measures should be made the object of research, designed to evaluate their safety and efficacy. In all cases, new information should be recorded and, where appropriate, published. The other relevant guidelines of this Declaration should be followed. © by BIO BASIC EUROPE S.r.l. Via A. Panizzi, 10 MILANO ITALY 18 Pag. 18 di 18 / page 18 out of

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