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A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne

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Vyne Therapeutics

Status and phase

Completed
Phase 3

Conditions

Acne Vulgaris

Treatments

Drug: FMX-101, 4% minocycline foam
Drug: Vehicle Foam

Study type

Interventional

Funder types

Industry

Identifiers

NCT02815267
FX2014-04

Details and patient eligibility

About

This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne vulgaris.

Enrollment

466 patients

Sex

All

Ages

9+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Has facial acne vulgaris with:

    • 20 to 50 inflammatory lesions (papules, pustules, and nodules);
    • 25 to 100 noninflammatory lesions (open and closed comedones);
    • no more than 2 nodules on the face; and
    • IGA score of moderate (3) to severe (4)
  • Willing to use only the supplied non-medicated cleanser (Cetaphil Gentle Skin 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 criteria

  • Acne conglobata, acne fulminans, secondary acne (chloracne, drug induced acne) or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations
  • Sunburn on the face
  • Severe systemic disease, which might interfere with the conduct of the study or the interpretation of the results.
  • Abnormal baseline laboratory values that are considered clinically significant
  • Allergy to tetracycline-class antibiotics or to any ingredient in the study drug
  • Pseudomembranous colitis or antibiotic-associated colitis

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

466 participants in 2 patient groups, including a placebo group

FMX-101, 4% minocycline foam
Experimental group
Description:
Subjects will apply the assigned FMX-101, 4% minocycline foam topically once daily for 12 weeks as directed
Treatment:
Drug: FMX-101, 4% minocycline foam
Vehicle foam
Placebo Comparator group
Description:
Subjects will apply the assigned vehicle foam topically once daily for 12 weeks as directed
Treatment:
Drug: Vehicle Foam

Trial documents
2

Trial contacts and locations

31

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Data sourced from clinicaltrials.gov

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