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Dietary Supplement

Clear Skin Formula for Acne

N/A

Recruiting

Research Sponsored by Ablon Skin Institute Research Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Subjects with more than 100 facial non-cystic acne non-inflammatory lesions (open and closed comedones)

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, day 14, day 28, day 56 and day 84 or end of study (up to 12 weeks)

Summary

This trial tests a supplement to reduce mild to moderate acne over 12 weeks in 18-40 yo men & women, with photos & questionnaires.

Who is the study for?

Healthy men and women aged 18-40 with mild to moderate non-cystic acne can join this study. They must have a certain number of facial acne lesions, agree to use specific skincare products provided by the sponsor, and for females, practice effective contraception. People using certain medications or treatments, those with other skin conditions or severe health issues, pregnant or nursing women, and individuals unable to follow the study protocol are excluded.

What is being tested?

The trial is testing VitaMedica® Clear Skin Formula capsules against placebo capsules over 12 weeks in participants with non-cystic acne. It aims to see if the supplement helps reduce acne symptoms better than a placebo. Participants will take daily supplements, have their faces photographed regularly, and answer questionnaires about their skin condition.

What are the potential side effects?

While not explicitly listed in the information provided, potential side effects may include digestive discomforts such as upset stomach or diarrhea since it's an oral supplement. Allergic reactions could occur but are likely rare given that it's designed for sensitive skin conditions like acne.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have between 10 and 50 non-cystic pimples on my face.

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I have between 10 and 100 non-inflammatory acne spots on my face.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have over 100 non-painful acne bumps on my face.

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I haven't used certain skin treatments on my face for the required time before starting this trial.

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I haven't taken high-dose vitamin A, steroids, antibiotics, or other systemic treatments recently.

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I haven't used any experimental drugs or devices in the last 30 days.

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I am not pregnant, nursing, planning to become pregnant, or become pregnant during the study.

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I do not have severe skin conditions on my face that could affect study assessments.

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I have more than 50 non-cystic pimples on my face.

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I have a history of chronic bowel conditions or severe diarrhea.

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I can communicate and cooperate with my doctor without issues.

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I haven't had cancer treatment in the last 6 months, except for skin cancer surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, day 14, day 28, day 56 and day 84 or end of study (up to 12 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, day 14, day 28, day 56 and day 84 or end of study (up to 12 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 14, day 28, day 56 and day 84 or end of study (up to 12 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in inflammatory lesion counts

Change in non-inflammatory lesion counts

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

Secondary study objectives

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

Change in Non-Cystic Acne Quality of Life questionnaire scores

Change in Non-Cystic Acne Self Assessment questionnaire scores

Other study objectives

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.

Changes in Clinical laboratory analyses of Complete Blood Count without Differential and with Platelets

Changes in Clinical laboratory analyses of Complete Metabolic Panel

+3 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: VitaMedica® Clear Skin Formula capsulesActive Control1 Intervention

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.

Group II: Placebo CapsulesPlacebo Group1 Intervention

0 / 12Eligibility criteria met