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

Acne Vulgaris Clinical Trial

Official title:

A Randomized, Double-Blind Study to Compare the Efficacy, Safety and Long-Term Safety of Topical Administration of FMX-101 for 1 Year in the Treatment of Moderate-to-Severe Acne Vulgaris, Study FX2014-04

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02815267
• Other study ID #: FX2014-04
• Status: Completed
• Phase: Phase 3
• Start date: May 2016
• Est. completion date: October 13, 2017

Study information

• Verified date: January 2022
• Source: Vyne Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 466
• Est. completion date: October 13, 2017
• Est. primary completion date: October 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• FMX-101, 4% minocycline foam
FMX-101, 4% minocycline foam applied topically once daily for 12 weeks
• Vehicle Foam
Vehicle foam applied topically once daily for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vyne Therapeutics Inc.

Countries where clinical trial is conducted

United States,  Dominican Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and Week 12
Primary	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.	Baseline and Week 12
Secondary	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).	Baseline and Week 12
Secondary	Absolute Change From Baseline in the Inflammatory Lesion Count at 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.	Baseline, at Week 6 and at Week 9
Secondary	Percentage of Participants Achieving IGA Treatment Success at 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.	Baseline, at Week 6 and at Week 9
Secondary	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and and Treatment-emergent Serious Adverse Events (TESAEs)	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.	Double blind: Screening Day until Week 12; Open-label: Week 16 until Week 52