To Evaluate the Efficacy and Safety of Minocycline Hydrochloride Foam in the Treatment of Moderate-to-severe Acne Vulgaris

Cutia Therapeutics

Status and phase

Completed

Phase 3

Conditions

Acne Vulgaris

Treatments

Drug: FMX101

Study type

Interventional

Funder types

Industry

Identifiers

NCT04960930

CU-10201-301

Details and patient eligibility

About

This is a randomized, multicenter, double-blind, vehicle-controlled, 2-arm study to evaluate the safety and efficacy in 12 weeks of FMX101 minocycline foam, 4%, compared to vehicle, in the treatment of subjects with moderate to severe facial acne vulgaris.

Full description

Qualified subjects will be randomized to receive 1 of the following 2 treatments:

FMX101 4% minocycline foam
Vehicle foam

Subjects with qualifying lesion counts and Investigator's Global Assessments (IGA) of acne severity scores and will be assigned to 1 of 2 treatments according to the randomization schedule. Subjects will apply the assigned study drug topically once daily for 12 weeks as directed. Subjects will be advised to apply the study drug at approximately the same time each day, preferably in the evening at bedtime. Both the Investigator and subject will be blinded to the study drug identity.

Subjects will return for visits at Weeks 1, 2, 4, 6, 8, and 12. At the discretion of the clinic staff, for the convenience of subjects or clinic staff, visits can be scheduled to occur 2 days before or after the nominal schedule date for the Weeks 1, 2, 4, 8 and 12 visits. Efficacy evaluations (acne lesion counts and IGAs) will be performed at each visit during the study.

Enrollment

372 patients

Sex

All

Ages

9+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Has completed and signed an appropriately administered Informed Consent Form (ICF) prior to any study-related procedures. Subjects less than 18 years of age (or as required by state law) must sign an Assent Form for the study and a parent or legal guardian must sign the ICF.
Has facial acne vulgaris with:
- 20 to 50 inflammatory lesions (papules, pustules, and nodules)
- 25 to 100 non-inflammatory lesions (open and closed comedones)
- No more than 2 nodules on the face
- 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.