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

Phase 3

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: FMX-101, 4% minocycline foam; Drug: Vehicle Foam

• Registration Number: NCT02815267
• Lead Sponsor: Vyne Therapeutics Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-24
• Study First Submitted QC: 2016-06-23
• Study First Posted: 2016-06-28
• Primary Completion: 2017-10-13
• Study Completion: 2017-10-13
• Disposition First Submitted: 2018-11-01
• Disposition First Submitted QC: 2018-11-01
• Disposition First Posted: 2018-11-05
• Results First Submitted: 2020-09-01
• Results First Submitted QC: 2020-09-01
• Results First Posted: 2020-09-22
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-13
• Last Update Posted: 2022-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 466

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FMX-101, 4% minocycline foam	FMX-101, 4% minocycline foam	Subjects will apply the assigned FMX-101, 4% minocycline foam topically once daily for 12 weeks as directed
Vehicle foam	Vehicle Foam	Subjects will apply the assigned vehicle foam topically once daily for 12 weeks as directed

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Investigator's Global Assessments (IGA) Treatment Success at Week 12	Baseline and 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.
Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12	Baseline and 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.

Secondary Outcome Measures

Name	Time	Method
Absolute Change From Baseline in the Inflammatory Lesion Count at Week 6 and Week 9	Baseline, at Week 6 and at Week 9	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.
Percent Change From Baseline in the Non-inflammatory Lesion Count at Week 12	Baseline and 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).
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and and Treatment-emergent Serious Adverse Events (TESAEs)	Double blind: Screening Day until Week 12; Open-label: Week 16 until Week 52	To evaluate the safety compared to vehicle of topical FMX101 4% administered daily for 12 weeks and to evaluate the long-term safety of topical FMX101 4% administered daily for up to an additional 40 weeks. TEAEs of the double-blind phase were defined as AEs starting on or after date of first application of investigational product (IP), but before the date of the first application of the open-label phase, and AEs starting on or after the first application of the open-label phase are considered as TEAEs of the open-label phase.
Percentage of Participants Achieving IGA Treatment Success at Week 6 and Week 9	Baseline, at Week 6 and at Week 9	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.