A Study to Evaluate the Efficacy and Safety of Clear Skin Formula on Mitigating Mild to Moderate Non-cystic Acne

Last updated: April 3, 2025
Sponsor: Ablon Skin Institute Research Center
Overall Status: Completed

Phase

N/A

Condition

Acne

Rash

Scalp Disorders

Treatment

Placebo Capsules

VitaMedica® Clear Skin Formula capsules

Clinical Study ID

NCT05879406
VM-CSF-01[
  • Ages 18-40
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Healthy male or females of all Fitzpatrick Skin Types between 18 and 40 years ofage.

  2. Subjects must be willing to provide verbal understanding and sign an InformedConsent Form, HIPAA Form and Photography Release Form approved by the InstitutionalReview Board.

  3. Subjects must be in general good health, as determined by the Investigator.

  4. Subjects must be willing and able to attend all study visits and comply with thetest product daily instructions.

  5. Subjects must be willing to have VISIA facial photography imaging of their entireface for overall evaluation of their skin at all Visits.

  6. Subjects must be willing and able to complete and understand the various ratingquestionnaires.

  7. Subjects must have a Modifed IGA score of 2 (mild) or 3 (moderate) at the BaselineVisit.

  8. Subjects must have a facial non-cystic acne inflammatory lesion (papules andpustules) count with no less than 10 but no more than 50.

  9. Subjects must have a facial non-cystic acne non-inflammatory lesion (open and closedcomedones) count with no less than 10 but no more than 100.

  10. Females of child bearing potential (FOCBP) and females who are premenses must bewilling to practice effective contraception for the duration of the study. (Effective contraception is defined as stabilized on oral contraceptive for at least 3 months, intrauterine device, condom with spermicide, diaphragm with spermicide,implant, NuvaRing®, injection, transdermal patch or abstinence.) Females on birthcontrol pills must have taken the same type pill for at least 3 months prior toentering the study and must not change type during the study. Those who have usedbirth control pills in the past must have discontinued usage at least 3 months priorto the start of the study. Women who use birth control for non-cystic acne controlonly should be excluded.

  11. Premenses females and FOCBP must have a negative urine pregnancy test at theBaseline Visit.

  12. Subjects must be willing to comply with study instructions and return to the clinicfor required visits.

  13. If a cleanser, moisturizer or sunscreen is needed during the study, subjects must bewilling to use the cleanser, moisturizer and sunscreen provided by the Sponsor.

  14. If the subject wears makeup, they must agree to use non-comedogenic makeup.

  15. Male subjects facial area must be clean-shaven for all study visits as to notinterfere with study assessment.

Exclusion

Exclusion Criteria:

  • Use of an investigational drug or device within 30 days of enrollment orparticipation in a research study concurrent with this study. 2. Any dermatologicalconditions on the face that could interfere with clinical evaluations such as cysticacne, acne conglobata, acne fulminans, secondary acne, perioral dermatitis,clinically significant rosacea, Gram-negative folliculitis, dermatitis, eczema. 3.Any underlying disease(s) or some other dermatological condition of the face thatrequires the use of interfering topical or systemic therapy or makes evaluations andlesion count inconclusive.

  1. Subjects with more than 50 facial non-cystic acne inflammatory lesions (papulesand pustules).

  2. Subjects with more than 100 facial non-cystic acne non-inflammatory lesions (open and closed comedones) 6. Subjects with facial acne cysts. 7. Subjectswith a facial beard or mustache that could interfere with the studyassessments.

  3. Subject has a history of experiencing significant burning or stinging whenapplying any facial treatment (eg, makeup, soap, masks, washes, sunscreens,etc) to their face. 9. Female subjects who are pregnant, nursing mothers,planning a pregnancy during the course of the study, or become pregnant duringthe study. 10. If female, subject has a history of hirsutism, polycysticovarian disease or clinically significant menstrual irregularities. 11. Historyof regional enteritis, ulcerative colitis, inflammatory bowel disease,pseudomembranous colitis, chronic or recurrent diarrhea, orantibiotic-associated colitis. 12. Treatment of any type of cancer within thelast 6 months, with the exception of complete surgical excision of skin canceroutside the treatment area. 13. Subjects who have not undergone the specifiedwashout period(s) for the following topical preparations/physical treatmentsused on the face or subjects who require the concurrent use of any of thefollowing in the treatment area:

Topical astringents and abrasives on the face 1 week Non-allowed moisturizers or sunscreens on the face 1 week Non-cystic Acne surgery 1 week Antibiotics on the face 2 weeks Other topical non-cystic acne drugs on the face 2 weeks Soaps containing antimicrobials on the face 2 weeks Light (e.g. LED, PDT) therapy on the face 2 weeks Anti-inflammatory agents and corticosteroids on the face 4 weeks Retinoids, including retinol on the face 4 weeks Chemical peel/Microdermabrasion on the face 4 weeks Laser therapy on the face 4 weeks

  1. Subjects who have not undergone the specified washout period(s) for the followingsystemic medications or subjects who require the concurrent use of any of thefollowing systemic medications:

High Dose Vitamin A and Beta-carotene Supplements 2 weeks Corticosteroids (including intramuscular injections) (inhaled corticosteroids are allowed) 4 weeks Antibiotics 4 weeks Other systemic treatments 4 weeks Systemic retinoids 6 months

  1. Subject intends to use a tanning booth or sunbathe during the study. 16. Subjectswho are unable to communicate or cooperate with the investigator due to languageproblems, poor mental development, or impaired cerebral function. 17. Subjects withany underlying disease that the investigator deems uncontrolled, and poses a concernfor the subject's safety while participating in the study.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Placebo Capsules
Phase:
Study Start date:
May 31, 2023
Estimated Completion Date:
January 23, 2024

Study Description

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.

Connect with a study center

  • Ablon Skin Institute & Research Center

    Manhattan Beach, California 90266
    United States

    Site Not Available

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