randomized controlled clinical dermatological study ...€¦ · randomized controlled clinical...

RANDOMIZED CONTROLLED CLINICAL DERMATOLOGICAL STUDY

SUBJECT TO HYPOALLERGENICITY TESTS

GOLDEN JOJOBA OIL BATCH GP-452

PROTOCOL Nº: 0102-11-09S TEST MATERIALS: jojoba oil LABORATORY: ECO OIL ARGENTINA S.A

CLAIM José Bonifacio 717

Buenos Aires

Argentina

CUSTOMER ECO OIL ARGENTINA S.A

RESPONSIBLE Dra. Patricia Noemí López

DATE OF THE FINAL REPORT September 08, 2011




Signatures

______________________ 08/09/11_____ Silvia H. Pérez Damonte Date Director

____________________________ 08/09/11_____ Patricia Noemí López Fecha Médica dermatóloga Date




1.0 Objective: The study aimed at assessing the safety of a product, whose INCI NAME is: SIMMONDSIA CHIMENSIS (JOJOBA) SEED OIL, regarding its sensitization potential in healthy volunteers according to the fully occlusive or semi occlusive Repeated Insult Patch Test “RIPT”, on the forearm and open application on the face. Instrumental measurement of the skin erythema and transepidermal water loss through bio engineering noninvasive techniques was also taken (references 1 to 7). 2.0 Customer

ECO OIL ARGENTINA S.A 2.1 Customer Representative Ing. Eduardo Quesada 3.0 Clinical Testing Facility The study was conducted by: CLAIM José Bonifacio 717 Buenos Aires Argentina 4.0 Clinical Investigators Study Director: Silvia H. Pérez Damonte, Ph.D. Pharmacist, Specialist in Cosmetic Production MN 11332

Medical Investigator: Dermatologist Patricia Noemí López, MN 91915- MP 447405 5.0 Study Dates Study initiation: August 05, 2011

Study final evaluation: September 02, 2011

6.0 Ethics 6.1 General The test protocol followed the American Society for Testing and Materials Standards (ASTM) and the Scientific Committee on Consumer Safety guidelines (SCCS) and abided by the international standards for clinical trials involving human subjects Good Clinical Practices (ICH - GCP) & World Medical Association. It was conducted according to the Declaration of Helsinki (1964), the Tokyo (1975), Venice (1983), Hong Kong (1989) amendments, CLAIM’s Policy Manual and National standards “Guideline for Good Clinical Practices of Investigation on Human Subjects”, according to Resolution 1490/2007, published in the Official Gazette in Argentina on 14/11/2007, pág.6. 6.2 Voluntary Subjects Information and Consent Volunteers, briefed about the purpose and nature of the study, granted their written consent prior to the test. 7.0 Product subject to the test The test articles used in this study was provided by ECO-OIL ARGENTINA S.A, delivered on August 2011 and identified as follows:

Golden Jojoba Oil batch GP-452 Quantity: 5 bottles of 125 ml each

Identification: GP-452

Physical description: lotion with characteristic smell 8.0 Test Subjects 15 female subjects, between 27 and 53 years old, with normal skin biotype were selected for this test. Each subject read, understood and signed the Acceptance Form and completed the brief case history form. 9.0 Procedure The test, conducted to prove dermal sensitization (RIPT) and account for the hypoallergenicity test, comprised three stages: a 7-day Induction phase, a 14-day Rest period and a 28-day Challenge phase, (counted as from the launching day). The first day at Claim, before launching the study, the voluntary subjects underwent skin assessments, forearm skin images were captured with a video microscope and the skin erythema and transepidermal water loss measured and taken as parameters of their basal rate. Later on, 0,03 g/cm2 of the product was applied and a Finn Chambers (known as

parch) placed on top for 24 hours. The patch was removed and a form was filled in with the test daily follow-up. After five days and repeated 6-hour application patches, the subjects would apply the product themselves at their houses leaving it for 24 hours, until they returned to Claim where patches were removed and the skin response assessed while the mentioned parameters were measured again to complete the Induction phase. During the Rest period, volunteers kept the zone under study “spotted”. Once this period ended, volunteers reapplied patches dosed with the cosmetic to complete the Challenge phase and returned once again to Claim with a 24-hour patch on. The skin erythema and transepidermal water loss measurement was repeated as well as the video microscope image registered. All images would be registered in a CD, whose protocol No. is 0102-11-09S. To prove the open application clinical study, volunteers were requested to wear the patch on their faces daily, during the whole test period. Clinical Aspects: The following clinical observation scale was used: erythema, desquamation, edema. Skin assessment was held at the beginning of the study, 24-hour after IP and during the last RIP 24-hour of the test.

Clinical Observation scale

Score Description

Erythema 0 No reaction 1 Mild 2 Moderate 3 Severe Score Description

Edema 0 No reaction 1 Mild 2 Moderate 3 Severe Store Description

Desquamation 0 No reaction 1 Mild 2 Moderate 3 Severe

Instrumental Assessment: C&K’s equipment Visioscan VC 98®, Mexameter® MX18 ® and the Tewameter® were used.

10.0 Results Table 1 – Clinical Dermatological Assessment. Induction Phase (Ref 1) Individual Scores Summary of volunteers’ dermatological assessments after repeated applications and 24-hour patch covers. Registered images in CD Protocol n°: 0102-11--09S

Nº Vol Initials Age Sex Response at 24h/7days

Dermatological Assessment. Induction Phase Forearm Zone

1 BB 27 F 000 GOOD 2 AS 45 F 000 GOOD 3 MC 41 F 000 GOOD 4 AG 48 F 000 GOOD 5 PM 39 F 000 GOOD 6 CR 30 F 000 GOOD 7 SGB 36 F 000 GOOD 8 MLU 35 F 000 GOOD 9 MS 44 F 000 GOOD

10 MC 45 F 000 GOOD 11 JM 39 F 000 GOOD 12 MGS 53 F 000 GOOD 13 SGS 45 F 000 GOOD 14 CS 33 F 000 GOOD 15 VF 28 F 000 GOOD

Chart Nº 1 Values corresponding to clinical skin response in relation to time. Fifteen voluntary subjects involved (100 % of the total population)

Induction Stage t=24 h

Table 2 – Clinical Dermatological Assessment. Challenge Stage (Ref 1) Individual Scores Summary of volunteers’ skin assessments after repeated applications and a 24-hour occlusive patch. Images registered in CD Protocol n°: 0102-11—09S


Dermatological Assessment. Induction Phase Forearm Zone

1 BB 27 F 000 GOOD 2 AS 45 F 000 GOOD 3 MC 41 F 000 GOOD 4 AG 48 F 000 GOOD 5 PM 39 F 000 GOOD 6 CR 30 F 000 GOOD 7 SGB 36 F 000 GOOD 8 MLU 35 F 000 GOOD 9 MS 44 F 000 GOOD


Chart Nº 2 Values corresponding to clinical skin response in relation to time. Fifteen volunteers involved (100 % of the total population).

Challenge Stage t=24 h

Table 3 – Clinical Dermatological Assessment: Face Zone


Dermatological Assessment. Induction Phase

Face Zone 1 BB 27 F 000 GOOD 2 AS 45 F 000 GOOD 3 MC 41 F 000 GOOD 4 AG 48 F 000 GOOD 5 PM 39 F 000 GOOD 6 CR 30 F 000 GOOD 7 SGB 36 F 000 GOOD 8 MLU 35 F 000 GOOD 9 MS 44 F 000 GOOD


Chart Nº 3 Values corresponding to the clinical skin response in relation to time. Fifteen volunteers involved (100 % of the total population).

T =28 days

RESULTS:

RANDOMIZED CONTROLLED CLINICAL DERMATOLOGICAL STUDY SUBJECT TO HYPOALLERGENICITY TESTS


Graphics ERYTHEMA AND TRANSEPIDERMAL WATER LOSS

Corresponds to nº= 15

Anti Irritation Quality

The test was conducted at constant 23ºC and 52% humidity level

References TEWL-values g/h/m’’

0-10 Very healthy condition

10-15 Healthy condition

15-25 NORMAL condition

25-30 Strained skin

Above 30 Critical condition 11.0 Conclusion: According to the test conducted, the product Golden Jojoba Oil Batch GP-452 was subject to clinical and technical tolerance tests of the fully occlusive and semi occlusive Skin Patch Test, and it proved to have good skin response. To prove the Hypoallergenic Claim, the Repeated Insult Patch test, also known as RIPT, was used, and no significant changes appeared on the forearm skin, or at the erythema value, subject to repeated occlusive applications. The same results were obtained from the transepidermal water loss measurement which maintained the established parameters without altering the skin barrier and proved the product good response. The clinical skin response in the face zone of open application was also good, therefore the product was found to be good for use. Therefore: Golden Jojoba Oil Batch GP-452 has been dermatologically tested and subjected to hypoallergenicity tests.

Appendix – References

Human Maximization Test. Modificado.Cosmesi Dermatologica.17.N° 74 .2001 Comité etico-scientifico Unipro

Lazar Paul. The Clinician and Reactions to Cosmetics. Toxicology and Applied Pharmacology Supplement 3:1969

Giovacchini Robert P. Premarket Testing Procedures of a Cosmetic Manufacturer. Toxicology and Applied Pharmacology Supplement 3:1969

Griffith John F. Predective and Diagnostic Testing for Contact Sensitization. Toxicology and Applied Pharmacology Supplement 3:1969

Kligman Albert M. Evaluation of Cosmetics for Irritancy. Toxicology and Applied Pharmacology Supplement 3:1969

Idson Bernard, Primary Irritation Testing. Toxicology and Applied Pharmacology Supplement 3:1969

Kligman Albert M and Frosch . Peter J. Method for appraising the stinging capacity of topically applied substances. . J. Soc. Cosmet. Chem; 28, 197-209 (May 1977)

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