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

• Registration Number: NCT02815280
• 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

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 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: 2020-10-21
• Results First Submitted QC: 2020-11-20
• Results First Posted: 2020-11-24
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-13
• Last Update Posted: 2022-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 495

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle Foam	Vehicle Foam	Vehicle foam applied topically once daily for 12 weeks
FMX-101, 4% minocycline foam	FMX-101, 4% minocycline foam	FMX-101, 4% minocycline foam applied topically once daily for 12 weeks

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
Percentage of Participants Achieving IGA Treatment Success at Week 6 and Week 9	Baseline, Week 6 and 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.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)	Double blind: From Baseline 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.
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).
Absolute Change From Baseline in the Inflammatory Lesion Count at Week 6 and Week 9	Baseline, Week 6 and 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.