AMA LABORATORIES
IMAGE ANALYSIS AND INVESTIGATION INTO THE OF STEMUTONE BODY SERUM INTENDED TO REDUCE THE APPEARANCE OF FINE LINES, WRINKLES, SAGGY SKIN, SAND PAPER SKIN (CREPEY) TEXTURE AND SKIN DRYNESS
MS10.INUSE.REP.L7664.GKL
October 21, 2011
It can be demonstrated that the Adonia StemuTone Body Serum (AMA Lab No.: L-7664) proved to be effective at reducing the appearance of fine lines, wrinkles, saggy skin, sand paper skin texture and dry skin look, on the body.
Data obtained through image analysis technology demonstrated that the Adonia StemuTone Body Serum regimen progressively reduced the appearance of fine lines, wrinkles, saggy skin, sand paper skin texture and dry skin look.
After 19 minutes the average reduction of fine lines, wrinkles, saggy skin, sand paper (crepey) skin texture and dry skin was 32%. These results improved to 61% after 14 days use and 78% after 28 days.
Maximum reduction of up to 88% was observed in the test population. Moreover, obtained results are considered statistically significant.
Further, this phenomenon was documented and confirmed by the photographic record made during the course of this study.
This study was conducted to evaluate the efficacy of a product intended to reduce the appearance of fine lines, wrinkles, saggy skin, sand paper skin (crepey) texture and skin dryness. Image analysis software was used to quantify changes observed in the scientifically matched photographs.
Test samples labeled StemuTone Body Serum, were received from Adonia Organics and assigned AMA Lab No.: L-7664.
Upon arrival at AMA Laboratories, Inc., the test material was assigned a unique laboratory code number and entered into a daily log identifying the lot number, sample description, sponsor, date received and tests requested.
Samples are retained for a period of three months beyond submission of final report unless otherwise specified by the sponsor or if sample is known to be in support of governmental applications, in which case retained samples are kept two years beyond final report submission. Sample disposition is conducted in compliance with appropriate federal, state and local ordinances.
Age Range....47-59
Standards for Inclusion in the Study:
- Female subjects, between the ages of 40 and 60 experiencing fine lines, sand paper skin texture and skin dryness.
- Individuals in normal health condition with no evidence of acute or chronic diseases, not having any known allergy to cosmetic products.
- Individuals willing to report to the test facility with clean skin.
- Individuals who completed a preliminary medical history form mandated by AMA Laboratories, Inc.
- Individuals, who read, understood and signed an informed consent document relating to the specific type of study to which they are subscribing. Consent forms are kept on file and are available for examination on the premises of AMA Laboratories, Inc. only.
- Individuals willing to cooperate with the Investigator comply with protocol and complete the full course of study.
- Individuals who have abstained from using any anti-aging, moisturizing and skin lightening products, for 72 hours prior to study initiation and use only the assigned test product for the duration of the study.
- Individuals who will abstain from tanning and will avoid sun exposure to test sites for a period of 72 hours prior to study commencement and for the duration of the study.
Standards for Exclusion from the Study:
- Subjects exhibiting rashes, scratches, birth marks etc., which might interfere with the evaluation of test results.
- Female volunteers who indicate that they are pregnant or lactating.
- Individuals who are under the care of a doctor.
- Individuals with active dermal lesions, warts, nevi, and moles on the test site observed at the time of evaluation.
- Individuals with known hypersensitivity to cosmetic products.
- Individuals who were taking any antibiotics, antihistamines, retinoid, anti-inflammatory or steroid therapy for two weeks prior to or during the study period.
- Individuals who were using systemic or topical medication for two weeks prior to or during the study period.
- Individuals who are participating in another study during the period of this study or who have participated in any other study within 1 month prior to this study.
Panel selection is accomplished by advertisements in local periodicals, community bulletin boards, phone solicitation, electronic media or any combination thereof.
An informed consent was obtained from each volunteer prior to initiating the study describing reasons for the study, possible adverse effects, associated risks and potential benefits of the treatment and their limits of liability. Panelists signed and dated the informed consent document to indicate their authorization to proceed and acknowledge their understanding of the contents. Each subject was assigned a permanent identification number and completed an extensive medical history form and screening form. These forms, along with the signed consent forms, are available for inspection on the premises of AMA Laboratories, Inc., only. Reference 21 CFR Ch.1 Parts 50, Subpart B.
Reference: CFR Title 21 Part 56, Subparts A, B, C and D. The IRB of AMA Laboratories, Inc. consists of five or more individuals, chosen from within the company for technical expertise and from the local community for lay interaction. The list of IRB members is kept on file at AMA Laboratories, Inc. and is available for inspection during the hours of operation.
Healthy females between the ages of 47 and 59 were included into this study. The subjects were pre-qualified for participation on the basis of inclusion and exclusion criteria (4.1 and 4.2). In order to pre-condition the test sites and keep all topical treatments constant for all test subjects, panelists were required to abstain from using any anti-aging, moisturizing and skin lightening products for a period of 72 hours prior to study commencement and use only the assigned test material during the test period.
On the initial day of the study each woman was evaluated for the presence of the study article condition, the test area was designated and photographed. Panelists were dismissed with the instruction to apply the test product according to the following instructions:
Use twice daily, once in the morning and before bedtime. Do not apply any sunscreen or other creams/lotions on top of product.
On the evaluation days (19 minutes, Day 14 and Day 28), panelists reported to the clinic without any topical treatments, having only applied the test material. Upon arrival, panelists were allowed to equilibrate to the ambient environment for 30 minutes prior to their pictures taken.
Detailed, high resolution matched digital photographs were taken prior to the initial application during the preliminary visit to the testing facility and again after 19 minutes, 14 and 28 days of use. Photographs were taken with fixed camera background, distances, angles, settings, lighting, panelist positioning, color bars, white balance, standardized and digitally certified unretouched. Each stage in the progression of the treatment regimen was photographically documented and the test area of involvement isolated. This set of photographs thus provided a visual record of the efficacy of the product on the subjects face.
Photographs were evaluated using image analysis software which allows capturing the areas of involvement (fine lines, sand paper skin texture and dry skin look).
No adverse effects or unexpected reactions of any kind were observed on any of the subjects.
No unexpected adverse reactions were observed on any of the subjects during the course of this study.
Wrinkles Reduction Analysis source data consist of fine lines, sand paper skin texture and dry skin look quantification in relative units (px), collected at Baseline, 19 minutes, Day 14 and Day 28 evaluation. The data used in the statistical analysis reflects changes from baseline. The size of the area of involvement differed for each test panelist, therefore percent difference was calculated individually and then averaged.
All original samples, raw data sheets, technician’s notes, correspondence files, copies of final reports and remaining specimens are maintained on the premises of AMA Laboratories, Inc. in marked limited access storage files. A duplicate DVD copy of final reports is separately archived in a bank safe deposit vault.
To prevent loss of and protect intellectual property, original, certified documents issued by AMA Laboratories, Inc. can be identified by a proprietary, tamper evident security hologram affixed to all Conclusion/Signature pages on final reports. Any attempt to remove the hologram will irreversibly damage the label and leave an immediate trace, thus invalidating the document.
Only reports containing the AMA LABS, INC. hologram intact will be recognized by AMA Laboratories Inc. as a certified original.
It can be demonstrated that the Adonia StemuTone Body Serum (AMA Lab No.: L-7664) proved to be effective at reducing the appearance of fine lines, wrinkles, saggy skin, sand paper skin texture and dry skin look, on the body.
Data obtained through image analysis technology demonstrated that the Adonia StemuTone Body Serum regimen progressively reduced the appearance of fine lines, wrinkles, saggy skin, sand paper skin texture and dry skin look.
After 19 minutes the average reduction of fine lines, wrinkles, saggy skin, sand paper (crepey) skin texture and dry skin was 32%. These results improved to 61% after 14 days use and 78% after 28 days.
Maximum reduction of up to 88% was observed in the test population. Moreover, obtained results are considered statistically significant.
Further, this phenomenon was documented and confirmed by the photographic record made during the course of this study.
