An Investigation into the Efficiency of Acne Treatment Regimen
Investigation was performed by an independent lab to evaluate the efficacy and tolerance of topically applied test products in the treatment regimen of mild to moderate facial acne over a 42 day period. In addition, product effectiveness was evaluated photographically via Reverse Photo Engineering.
The Institutional Review Board of AMA Laboratories, Inc., consists of five or more individuals, chosen from within the company for technical expertise and also 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.
Standards for Inclusion in Study:
A. Male and/or female subjects 18 years of age or older with mild to moderate facial acne as confirmed by the Study Director.
B. Individuals who will complete a preliminary medical history and screening document as mandated by AMA Laboratories, Inc.
C. Individuals, who will read, understand and sign an informed consent document as required by Reference 21 CFR Ch. 1
Part 50, Subpart B. Consent forms will be kept on file and will be available for examination on the premises of AMA
Laboratories, Inc., only.
D. Individuals in general good health and free of any health problems, including neurological, dermatological, or systemic disorder
that would interfere with the results, at the discretion of the Study Director.
E. Individuals able to cooperate with the Investigator and research staff, willing to have the test material(s) applied
according to the protocol, and complete the full course of study.
F. Individuals who have abstained from using any anti-acne products for a period of 72 hours prior to study commencement
and who will use only the assigned test material during the test period.
Five panelists exhibiting mild to moderate (Grade 2-3) facial acne were inducted into this study. All participants were advised of the general nature and purpose of the study, and were required to complete medical history form and informed consent document. Subjects were mandated to adhere to all the restrictions mentioned in the inclusion/exclusion criteria.
On the initial day of the study, Study Director graded acne condition of each panelist using the Investigator's Global Assessment Scale for Acne Vulgaris recommended by FDA 2005 guidance.IGA Scale for Acne Vulgaris (Ref. 1):
0 - Clear almost with no inflammatory or non-inflammatory lesions
1 - Almost clear; rare non-inflammatory lesions with no more than one small inflammatory lesion
2 - Mild severity; greater than Grade 1; some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions)
3 - Moderate severity; greater than Grade 2; up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion
4 - Severe; greater than Grade 3; up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions
The study was conducted according to sponsor requested design wherein all subjects were instructed to apply the test products twice daily (morning and evening) to the acne affected facial areas following Steps 1, 2 and 3 for a period of 42 days as follows:
Step 1 - Redefining Cleanser:
1. Wet face with water.
2. Squeeze a few drops of Zimaxa Redefining Cleanser into the palm of your hand.
3. Apply Zimaxa Redefining Cleanser to the face, avoiding the eye area. Gently work the cleanser into a lather using fingertips or ZimaxaSponge.
4. Rinse face with lukewarm water.
5. Follow up with Zimaxa Deep Pore Exfoliator for enhanced results.
Step 2 - Deep Pore Exfoliator:
1. Zimaxa Deep Pore Exfoliator can be used in the morning and/or evening after the Zimaxa Redefining Cleanser.
2. Saturate Zimaxa Sponge or gauze pad with Zimaxa Deep Pore Exfoliator.
3. Use the pad to gently buff the areas you want to target and treat.
4. Rinse skin with warm water.
5. Follow up with Zimaxa Spot Treat to problem areas.
Step 3 - Spot Treat:
1. Apply Zimaxa Spot Treat to the affected areas 1 to 3 times daily or as needed.
2. May be used under make-up.
All study participants were provided with a brief diary to record time of test material application along with any comments related to product usage.
On each evaluation day (at baseline, days 1, 2, 3, 4, 7, 30 and 42) counts of visible inflammatory and non-inflammatory lesions associated with the acne condition were conducted.
Subjects were instructed to report any adverse reaction; which might occur during the course of the study. Clients are notified immediately in the case of an adverse reaction and a determination is made as to treatment regimen, if necessary.
Reverse Photo Engineering
Exclusively detailed, high resolution digital photographs were taken at each evaluation time point, with fixed camera background, angles, settings, lighting, panelist positioning, color bars, white balance, standardized and digitally certified unretouched. Photographs were evaluated using image analysis software which allows the evaluation parameter to be captured and quantified.
Within the limits imposed by the conduct and population size of the study described herein, the following conclusions are drawn:
M-7634, zimaxa ADVANCED CLEAR SKIN SOLUTION 1 redefining cleanser, Lot 209286 expo 04/15
M-7635, zimaxa ADVANCED CLEAR SKIN SOLUTION 2 deep pore exfoliator, Lot 1335 expo 02/15
M-7636, zimaxa ADVANCED CLEAR SKIN SOLUTION 3 spot treatment, Batch # 1679 expo 07/15
M-7637, zimaxa JUST FACE IT 2012.04.03
proved to be an effective treatment regimen in improving facial acne condition by reducing acne lesion counts as well as improving skin's overall appearance. Moreover, reduction in total Acne lesion counts is considered statistically significant at Day 2 through Day 42 evaluation time points.
The study showed that Zimaxa when taken according to directions, there was a reduction in Total Acne Lesion Counts considered statistically significant from Day 2 through Day 42 evaluation points.
Data obtained through image analysis software demonstrated that the test product regimen reduced the appearance of acne as follows: CASE 1 CASE 2 CASE 3 CASE 4