Our Marrák Hair Recovery Crème has been tested in humans by a USFDA recognized third-party clinical trials laboratory (CFR Title 21 Part 56, Subparts A, B, C, and D) and determined to be safe when used as directed. Our products passed Repeat Insult Patch Test (RIPT), Skin Patch Test, and Preservative Efficacy Test (PET). Additionally, our products have been proven stable for two years (PET). A more detailed review of the results of the specific tests conducted is provided below.
48 Hour Patch Test-Skin Irritation Evaluation (Occlusive Patch):
Parke-Davis Hypoallergenic Readi-Patch was used. Fifty healthy individuals (18-66 of age; 7 males and 43 females; and included 38 Caucasians, 9 Hispanics, and 3 Asians) participated and finished the study.
After applying the occlusive hypoallergenic patch for 48 hours, no adverse reactions of any kind were noted during the course of the study.
The test material (Marrák Hair Recovery Crème) when tested under 48 hour occlusive patching conditions as described in the protocol may be considered a NON-PRIMARY IRRITANT to the skin. This study was conducted under the supervision of well trained Dermatologist (Study Director).
This study was inspected in accordance with the Standard Operating Procedures of AMA Laboratories, Inc. To assure compliance with the study protocol, the Quality Assurance Unit completed an audit of the study records and report.
Fifty Human Subject Repeat Insult Patch Test (RIPT)- Skin Irritation/Sensitization Evaluation (Occlusive Patch):
Parke-Davis Hypoallergenic Readi-Bandages or equivalent were used. Fifty one healthy individuals (18-67 of age; 11 males and 40 females; and included 46 Caucasians, 4 Hispanics, and 1 Asian) participated and finished the study except an individual who dropped off the study.
The occlusive hypoallergenic patch is applied for 24 hours. After 24 hours the patch is removed by the volunteer at home. This procedure is repeated until a series of nine consecutive 24 hour exposures have been made for every Monday, Wednesday, and Friday for three consecutive weeks. Subjects are then given a 10-14 days rest period after which a challenge or retest dose is equivalent to any one of the original nine exposures. Reactions are scored 24 and 48 hours after application. Comparison is made between the nine inductive responses and the retest dose. At the conclusion of the study, the consulting Dermatologist reviewed this data and confirmed the stated conclusion.
After applying the repeated occlusive hypoallergenic patch, no adverse reactions of any kind were noted during the course of the study.
The test material (Marrák Hair Recovery Crème) when tested under occlusion patching conditions of Repeated Insult Patch Test (RIPT) as described in the protocol may be considered a NON-PRIMARY IRRITANT and NON-PRIMARY SENSITIZER to the skin according to the reference (Appraisal of the Safety of Chemicals in Food, Drugs, and Cosmetics, published by the Association of Food and Drug Officials of the United States, 1965 (modified)). This study was conducted under the supervision of well trained Dermatologist (Study Director).
Preservative Efficacy Testing (PET)
Accelerated Preservative Challenge Testing (APCT)
Procedure (Brief): Aliquots (samples) of Marrák Hair Recovery Crème were inoculated with separate mixed cultures of bacteria and fungi. Plate counts (to dermic survivor) were performed at 0 time and after 1, 3, 7, and 14 days after inoculation. Samples were reinoculated at both 0 time and 7 days. Results are presented as the number of surviving organisms present at each time interval per gram of product tested. Inoculum levels are ~10 million per gm for the mixed bacteria and 100,000 per gm for the mixed fungi.
Mixed bacteria: Pseud. aeruginosa (ATCC 9027); E. coli (ATCC 9027); E. coli (ATCC 8739); S. aureus (ATCC 6538).
Mixed Fungi: A. brasilienis (ATCC 16404 old niger); C. albicans (ATCC 10231); Penicillium species (ATCC 9644).
The sample of Marrák Hair Recovery Crème has passed the modified Accelerated Double Challenge Preservative Testing protocol.
The test sample demonstrated excellent activity against bacteria with the inoculum wing eliminated within 72 hours with no recovery observed at any other test point. Marginal antifungal activity was demonstrated.
This Marrák Hair Recovery Crème is considered acceptable as per the USP and PCPC (CTFA) criteria of acceptability.
In addition to PET other stability tests were conducted and revealed that Marrák Hair Recovery Crème has a shelf life of 2 years.