Status:
COMPLETED
A Study to Compare FCD105 Foam to Minocycline 3% Foam, Adapalene 0.3% Foam and Vehicle Foam.
Lead Sponsor:
Vyne Therapeutics Inc.
Conditions:
Acne Vulgaris
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief Summary
A study comparing FCD105 to 3% minocycline foam, 0.3% adapalene foam and vehicle foam in patients ≥ 12 years old for the treatment of moderate-to-severe acne.
Eligibility Criteria
Inclusion
- Has facial acne vulgaris with all of the following:
- 20 to 50 inflammatory lesions (papules and/or pustules) on the face.
- 25 to 100 non-inflammatory lesions (open and closed comedones) on the face.
- IGA score of moderate (3) to severe (4).
- No more than two active nodules on the face.
- Willing to use only the supplied non-medicated cleanser and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study
Exclusion
- Female who is pregnant or lactating, or is planning a pregnancy during the study.
- Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any dermatological condition of the face that could interfere with the clinical evaluations.
- Facial hair (eg, beard, mustache, etc.) that could interfere with the clinical evaluations.
- Sunburn on the face.
- Severe systemic disease as assessed by the Investigator that might interfere with the conduct of the study or the interpretation of the results.
- Subjects who have a documented history of any of the following:
- Allergy to tetracycline-class antibiotics or to any ingredient in the study drug.
- Pseudomembranous colitis or antibiotic-associated colitis.
- Hepatitis or clinically significant liver damage or clinically significant renal impairment.
- Known or suspected premalignant or malignant disease (excluding successfully treated skin cancers).
- Subjects who have used the following medications:
- Within 1 week prior to randomization:
- Medicated facial cleansers on the face.
- Topical acne treatments on the face (other than those listed below).
- Within 4 weeks prior to randomization:
- Topical retinoids on the face.
- Topical anti-inflammatories and/or corticosteroids on the face.
- Topical corticosteroids on body areas other than the face for more than 15 consecutive days and on more than 10% of the body surface area. In body folds, such as axillary and inguinal regions, only mild topical steroids are allowed for short term use (≤15 consecutive days).
- Systemic antibiotics.
- Systemic acne treatments.
- Within 12 weeks prior to randomization:
- Systemic retinoids.
- Systemic corticosteroids (Note: Intranasal and inhaled corticosteroids may be used throughout the study if the subject is on a stable dose).
- Use of sauna during the 2 weeks prior to randomization.
- Epilation of the face within 2 weeks prior to randomization.
- Folliculitis on the face.
- Documented history of depression that is not, in the opinion of the Investigator, currently adequately controlled with medication
Key Trial Info
Start Date :
September 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2020
Estimated Enrollment :
446 Patients enrolled
Trial Details
Trial ID
NCT04104685
Start Date
September 18 2019
End Date
March 3 2020
Last Update
February 5 2021
Active Locations (35)
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1
Foamix Institution #134
Bryant, Arkansas, United States, 72022
2
Foamix Institution #121
Rogers, Arkansas, United States, 72758
3
Foamix Institution #106
Encino, California, United States, 91436
4
Foamix Institution #103
Fremont, California, United States, 94538