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

Vyne Therapeutics Inc.495 enrolled

Overview

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.

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. The first 12 weeks of the study involves randomized, double-blind treatment with active FMX-101, 4% or matching vehicle. Subjects who successfully complete the 12-week double blind portion of the study will be offered the opportunity to continue in the trial for up to an additional 40 weeks (for a total of 1 year) and receive open-label treatment with FMX-101, 4%.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

495

Conditions

Acne Vulgaris

Interventions

FMX-101, 4% minocycline foamDRUG

FMX-101, 4% minocycline foam applied topically once daily for 12 weeks

Vehicle FoamDRUG

Vehicle foam applied topically once daily for 12 weeks

Eligibility

Sex: ALLMin age: 9 Years

Medical Language ↔ Plain English

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 * 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

Locations (36)

Outcomes

Primary Outcomes

Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12

To evaluate the efficacy in the treatment of acne compared to vehicle of topical FMX101 4% administered daily for 12 weeks. Changes from Baseline are calculated as Baseline value minus post-Baseline value, so that decreases appear as positive values. Inflammatory lesion count included: papules, pustules, and nodules.

Time frame: Baseline and Week 12

Percentage of Participants Achieving Investigator's Global Assessments (IGA) Treatment Success at Week 12

The IGA scale for acne vulgaris, was used by the investigators to assess the severity of a participant's acne vulgaris. The scale ranges from 0 (Clear): normal, clear skin with no evidence of acne vulgaris to 5 (Very Severe): highly inflammatory lesions predominate, variable number of comedones, many papules/pustules and many nodulocystic lesions. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (score of clear) or 1 (almost clear), and at least a 2-grade improvement (decrease) from Baseline.

Time frame: Baseline and Week 12

Secondary Outcomes

Percent Change From Baseline in the Non-inflammatory Lesion Count at Week 12

To evaluate the efficacy in the treatment of acne compared to vehicle of topical FMX101 4% administered daily for 12 weeks. Percent change from baseline is calculated as the baseline value minus the post-baseline value divided by the baseline value, expressed as a percentage. Non-inflammatory lesions included: open comedones (blackhead) and closed comedones (whitehead).

Time frame: Baseline and Week 12

Absolute Change From Baseline in the Inflammatory Lesion Count at Week 6 and Week 9

Data from ClinicalTrials.gov

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