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

NCT05879406 | Completed

• 1 other identifier: VM-CSF-01[
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-Cystic Acne

Outcome Measures

Primary Outcomes (3)

• Change in inflammatory lesion counts

  Papule - A small, solid elevation less than 5 mm in diameter. Most of the lesion is above the surface of the skin. Pustule - A small circumscribed elevation less than 5 mm in diameter that contains yellow-white exudate.

  Baseline to Day 84

• Change in non-inflammatory lesion counts

  Open Comedone - (Blackhead) A lesion in which the follicle opening is widely dilated with the contents protruding out onto the surface of the skin, with exposed keratin cells giving the plug a black appearance. Closed Comedone - (Whitehead) A lesion in which the follicle opening is closed, with sebum buildup, which in turn cause the skin around the follicle to thin and become elevated with a white appearance.

  Baseline to Day 84

• Percentage/Proportion of subjects who achieve at least a one-grade reduction in the Modified IGA Score

  Modified Investigator Global Assessment (IGA) Scale for Non-Cystic Acne The Investigator will use the Modified Investigator Global Assessment (IGA) Scale to assess the severity of a subjects' non-cystic acne. The Modified IGA Scale is a static evaluation of global severity representing clinically meaningful graduations of non-cystic acne. The Modified IGA should be performed prior to the lesion count. The Modified IGA will be performed at visits: Baseline, Day 14, Day 28, Day 56,Day 84 or Early Termination. Subjects are eligible for enrollment if they have facial non-cystic acne with a global severity grade of a 2 (mild) or a 3 (moderate) on the Modified IGA scale at Baseline.

  Baseline to Day 84

Secondary Outcomes (3)

• Change in Non-Cystic Acne Quality of Life questionnaire scores

  Baseline to Day 84

• Change in Non-Cystic Acne Self Assessment questionnaire scores

  Baseline to Day 84

• Change in Analysis of the Clear Skin Formula Supplement Subject Satisfaction questionnaire

  Day 84/End of Study

Other Outcomes (6)

• Change 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.

  Baseline to Day 84

• The frequency of both local and systemic AEs

  Baseline, Day 14, Day 28, Day 56 and Day 84 or End of Study (up to 12 weeks)

• Investigator Tolerability Assessment (erythema, edema, dryness, scaling, hypopigmentation and hyperpigmentation)

  Baseline, Day 14, Day 28, Day 56 and Day 84 or End of Study (up to 12 weeks)

Study Arms (2)

VitaMedica® Clear Skin Formula capsules

ACTIVE COMPARATOR

Storage Instructions: Store in a cool, dry place. Contents: 60 Capsules Directions for Use: As a dietary supplement, take two capsules with food. Caution: Do not take if safety seal on bottle is broken. KEEP OUT OF REACH OF CHILDREN.

Dietary Supplement: VitaMedica® Clear Skin Formula capsules

Placebo Capsules

PLACEBO COMPARATOR

Storage Instructions: Store in a cool, dry place. Contents: 60 Capsules Directions for Use: As a dietary supplement, take two capsules with food. Caution: Do not take if safety seal on bottle is broken. KEEP OUT OF REACH OF CHILDREN.

Other: Placebo Capsules

Interventions

VitaMedica® Clear Skin Formula capsules DIETARY_SUPPLEMENT

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 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

VitaMedica® Clear Skin Formula capsules

Placebo Capsules OTHER

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 Ingredients: Magnesium Stearate (VEG) (NON-GMO) Silica (As Silicon Dioxide) Micro Cellulose (MCG) (NON-GMO)

Placebo Capsules

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or females of all Fitzpatrick Skin Types between 18 and 40 years of age.
• Subjects must be willing to provide verbal understanding and sign an Informed Consent Form, HIPAA Form and Photography Release Form approved by the Institutional Review Board.
• Subjects must be in general good health, as determined by the Investigator.
• Subjects must be willing and able to attend all study visits and comply with the test product daily instructions.
• Subjects must be willing to have VISIA facial photography imaging of their entire face for overall evaluation of their skin at all Visits.
• Subjects must be willing and able to complete and understand the various rating questionnaires.
• Subjects must have a Modifed IGA score of 2 (mild) or 3 (moderate) at the Baseline Visit.
• Subjects must have a facial non-cystic acne inflammatory lesion (papules and pustules) count with no less than 10 but no more than 50.
• Subjects must have a facial non-cystic acne non-inflammatory lesion (open and closed comedones) count with no less than 10 but no more than 100.
• Females of child bearing potential (FOCBP) and females who are premenses must be willing 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 birth control pills must have taken the same type pill for at least 3 months prior to entering the study and must not change type during the study. Those who have used birth control pills in the past must have discontinued usage at least 3 months prior to the start of the study. Women who use birth control for non-cystic acne control only should be excluded.
• Premenses females and FOCBP must have a negative urine pregnancy test at the Baseline Visit.
• Subjects must be willing to comply with study instructions and return to the clinic for required visits.
• If a cleanser, moisturizer or sunscreen is needed during the study, subjects must be willing to use the cleanser, moisturizer and sunscreen provided by the Sponsor.
• If the subject wears makeup, they must agree to use non-comedogenic makeup.
• Male subjects facial area must be clean-shaven for all study visits as to not interfere with study assessment.

You may not qualify if:

• Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study. 2. Any dermatological conditions on the face that could interfere with clinical evaluations such as cystic acne, 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 that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive.
• \. Subjects with more than 50 facial non-cystic acne inflammatory lesions (papules and pustules).
• \. Subjects with more than 100 facial non-cystic acne non-inflammatory lesions (open and closed comedones) 6. Subjects with facial acne cysts. 7. Subjects with a facial beard or mustache that could interfere with the study assessments.
• \. Subject has a history of experiencing significant burning or stinging when applying 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 during the study. 10. If female, subject has a history of hirsutism, polycystic ovarian disease or clinically significant menstrual irregularities. 11. History of regional enteritis, ulcerative colitis, inflammatory bowel disease, pseudomembranous colitis, chronic or recurrent diarrhea, or antibiotic-associated colitis. 12. Treatment of any type of cancer within the last 6 months, with the exception of complete surgical excision of skin cancer outside the treatment area. 13. Subjects who have not undergone the specified washout period(s) for the following topical preparations/physical treatments used on the face or subjects who require the concurrent use of any of the following 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
• \. Subjects who have not undergone the specified washout period(s) for the following systemic medications or subjects who require the concurrent use of any of the following 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
• \. Subject intends to use a tanning booth or sunbathe during the study. 16. Subjects who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function. 17. Subjects with any underlying disease that the investigator deems uncontrolled, and poses a concern for the subject's safety while participating in the study.

Sponsors & Collaborators

• Ablon Skin Institute Research Center: lead
• Grove Acquisition Subsidiary dba VitaMedica: collaborator

Study Sites (1)

Ablon Skin Institute & Research Center

Manhattan Beach, California, 90266, United States

Location

Related Publications (1)

• Ablon G. A 12-week, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of a Nutraceutical Supplement for Mild to Moderate Non-cystic Acne in Young Adults. J Clin Aesthet Dermatol. 2024 Nov;17(11):24-30.

  PMID: 39758223 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Randomized, double-blind, placebo controlled study evaluating the efficacy and safety
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo controlled study evaluating the efficacy and safety

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 30, 2023
• Study Start: May 31, 2023
• Primary Completion: January 23, 2024
• Study Completion: January 23, 2024
• Last Updated: April 6, 2025

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)