Non-Cystic Acne Clinical Trial
Official title:
A 12-week, Randomized, Double-blind, Placebo Controlled Study Evaluating the Efficacy and Safety of Clear Skin Formula on Mitigating Mild to Moderate Non-cystic Acne in Young Healthy Adults
The goal of this clinical trial is to compare Clear Skin Fomula Supplement to Placebo in healthy men and women ages 18-40 to mitigate mild to moderate non-cystic acne over the course of 12 weeks. Participants will be asked to take a daily supplement, have photos of their face taken and answer questionnaires related to their acne.
Non-cystic acne is a common disorder of sebaceous follicles most prevalent among teenagers, has a multifactorial etiology often triggered by the increase in androgen production, and yet, approximately 3% to 8% of adults 25 to 44 years of age continue to have breakouts. The pathogenesis is complex and appears to involve 4 primary features: increased stimulation of sebum gland activity, increased bacterial proliferation (especially Propionibacterium acnes), abnormal follicular hyperkeratinization and resultant obstruction of the sebaceous follicles, and the release of inflammatory mediators. These changes in non-cystic acne patients result in the formation of non-inflammatory and inflammatory lesions including superficial pustules such as comedones (popularly known as "blackheads" or "whiteheads") and papules. The areas most affected by the non-cystic acne include the pilosebaceous follicles of the head and upper trunk, where the sebaceous glands are particularly active. With the complexity of the pathogenic mechanisms leading to non-cystic acne, consensus guidelines recommend the use of combination therapy including various topical applications (retinoids, antibiotics, salicylic acid, dapsone); oral medications (antibiotics, oral contraceptives, anti-androgen agents, isotretinoin); and numerous other therapies (light therapy, steroid injection, chemical peel, comedone extraction). While the standard treatments for non-cystic acne have varying degrees of effectiveness, significant side-effects including but not limited to skin dryness, irritation, redness, and disturbance of the skin and gut microbiome can occur. Importantly, overprescribing of antibiotics has contributed to antibiotic resistance and reduction of efficacy for these medications. Use of nutritional supplements as a component of non-cystic acne treatments has increased in popularity due to credible clinical validation and acceptance by the medical community, as well as reported advantages such as better patient tolerance, minimal side-effects, widespread availability and reduced expense versus prescription and over the counter products. Specifically Vitamin A and Carotenoids (the basis of the prescription Isotretinoin), have shown to serve as substitutes when Isotretinoin is inaccessible. Since the progression of non-cystic acne produces free radicals, oxidative stress may be implicated in the origin of non-cystic acne, so that antioxidant vitamins may be valuable adjuncts in non-cystic acne treatment. Additional Vitamins and Minerals have also shown substantial improvement in non-cystic acne. Although a clinical study has not been previously conducted on VitaMedica® Clear Skin Formula, extensive clinical and patient use data support further investigation. For two decades hundreds of aesthetic and dermatology medical practices in the U.S. have utilized or recommended this VitaMedica® Clear Skin Formula as a safe and effective adjunctive therapy for their non-cystic acne patients. To date, more than 140,000 individual patients have used this dietary supplement in conjunction with their usual treatment regimens. As the causes of non-cystic acne are multifactorial, and resources to common prescription medications can be costly and frequently ineffective, finding alternative therapies is crucial. Investigators know that diet and nutrition affect all conditions of the skin, gut and brain, so it is logical to infer that vitamins and supplements, while proving successful in treating a multitude of dermatologic conditions, including hair loss, connective tissue disorders, psoriasis and other papulosquamous disorders, could also help mitigate non-cystic acne. Because of this data, two decades ago the VitaMedica® Clear Skin Formula was developed. It includes the following ingredients: Vitamin A (from Betatene® Carotenoid Blend) (7,500 IU/2,250 mcg RAE) Vitamin A (from Retinyl Palmitate) (5,000 IU/1,500 mcg RAE) Vitamin C (as Ascorbic Acid) (60 mg) Vitamin E (from d-alpha-Tocopheryl Acid Succinate) (30 IU/20 mg) Zinc (from Zinc Bisglycinate Chelate) (24 mg) Selenium (from Selenium Glycinate) (48 mcg) Chromium (from Chromium Nicotinate Glycinate Chelate) (150 mcg) MSM (Methylsulfonylmethane) (200 mg) Bromelain (200 mg) Burdock (Arctium lappa) root (50 mg) Oregon Grape (Mahonia aquifolium) root (25 mg) Dandelion (Taraxacum officinale) root (50 mg) Yellow Dock Extract (Rumex crispus) root (50 mg) Hypromellose Microcrystalline cellulose Magnesium Stearate Silicon Dioxide This is a twelve (12) week double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of VitaMedica® Clear Skin Formula in the mitigation of mild to moderate non-cystic acne in young, healthy males and females ages 18-40. After an initial screening period to determine eligibility, subjects will be randomly assigned to one of the following treatment arms: VitaMedica® Clear Skin Formula vs. Placebo for the duration of the twelve (12) week trial at Visit 2 (Day 0). Subjects will return to the study site at Visit 3 (Day 14), Visit 4 (Day 28), Visit 5 (Day 56) and Visit 6 (Day 84) for assessments. The primary efficacy endpoints are to be evaluated using the following parameters: 1. Change in inflammatory lesion counts from Baseline to Day 84. 2. Change in non-inflammatory lesion counts from Baseline to Day 84. 3. Percentage/Proportion of subjects who achieve at least a one-grade reduction in the Modified IGA Score from Baseline to Day 84. The secondary efficacy endpoints are to be evaluated using the following parameters: 1. Improvement in Non-Cystic Acne Quality of Life questionnaire scores from Baseline to Day 84. 2. Improvement in Non-Cystic Acne Self Assessment questionnaire scores from Baseline to Day 84. 3. Favorable Analysis of the Clear Skin Formula Supplement Subject Satisfaction questionnaire at Day 84. The tertiary efficacy endpoints are to be evaluated using the following parameters: 1) Improvement from Baseline to Day 84 in the VISIA photography imaging of the left, right and front views of the face to include the (1) Percentile Rating, (2) Score Rating and (3) Feature Count Rating for Wrinkles, Texture, Pores, Red Areas and Porphyrins. The tolerability and safety objectives of this study are: To determine the nature, severity and frequency of the AEs rate and the local cutaneous tolerability of VitaMedica® Clear Skin Formula compared to the placebo. The tolerability and safety endpoints to be assessed include the following: 1. The frequency of both local and systemic AEs 2. Investigator Tolerability Assessment (erythema, edema, dryness, scaling, hypopigmentation and hyperpigmentation) and Subject Tolerability Self-Assessment (itching, burning and stinging) at Baseline and at all study visits. 3. Changes from baseline to Day 84 in all safety laboratory values as summarized using descriptive statistics by treatment group. ;