Acne Vulgaris
Conditions
Brief summary
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.
Detailed 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.
Interventions
DRUGFMX101
topically once daily
Sponsors
Cutia Therapeutics (Shanghai) Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Drug: FMX101 FMX101, 4% minocycline foam Drug: Vehicle Foam Vehicle Foam
Eligibility
Sex/Gender
ALL
Age
9 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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. 2. 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) 3. 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
1. 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. 2. Sunburn on the face.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ILC | Week12 | The efficacy assessments will inflammation lesion counts at week12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| nILC | week 12 | The efficacy assessments will non-inflammation lesion counts at baseline and week12 |
| ILC week4 | week 4 | The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 4 |
| Investigator Global Assessment (IGA) | week 12 | Severity of acne vulgaris assessed by Investigator Global Assessment (IGA) IGA Scale for Acne Vulgaris for study is 0-5, score 0 is clear and normal, and score 5 is very severe. |
| Investigator Global Assessment (IGA) week4 | Week 4 | IGA Treatment Success at Week 4 IGA Scale for Acne Vulgaris for study is 0-5, score 0 is clear and normal, and score 5 is very severe. |
| Investigator Global Assessment (IGA) week8 | Week 8 | IGA Treatment Success at Week 8 IGA Scale for Acne Vulgaris for study is 0-5, score 0 is clear and normal, and score 5 is very severe. |
| ILC week8 | week 8 | The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 8 |
Countries
China
Outcome results
None listed