A Study Comparing Two Topicals in the Treatment of Acne Vulgaris

Phase 1

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: FMX101 vehicle; Other: Hydro-alcohol solution

• Registration Number: NCT03743038
• Lead Sponsor: Vyne Therapeutics Inc.

Brief Summary

A Randomized, Evaluator-Blinded, Bilateral Comparison Study to Evaluate the Safety and Efficacy of Two Topicals in the Treatment of Subjects With Acne Vulgaris (Study FX2018-23).

Detailed Description

A Randomized, Evaluator-Blinded, Bilateral Comparison Study to Evaluate the Safety and Efficacy of Two Topicals in the Treatment of Subjects With Acne Vulgaris. Eligible subjects will be randomized (1:1) to treatment with Test Article A to one side of the face versus Test Article B on the contralateral side.

Study Timeline

• Study First Submitted: 2018-11-10
• Study First Submitted QC: 2018-11-14
• Study First Posted: 2018-11-15
• Study Start: 2018-11-20
• Primary Completion: 2019-02-11
• Study Completion: 2019-02-11
• Results First Submitted: 2021-01-07
• Results First Submitted QC: 2021-02-04
• Results First Posted: 2021-02-23
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-11
• Last Update Posted: 2021-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Has facial acne vulgaris with:

  16 inflammatory lesions (papules, pustules) The inflammatory lesion count on the right and left side of the face should be similar IGA score of moderate (3) on both the right and left side of the face

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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.
• More than two facial nodules/cysts
• Sunburn on the face

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FMX101 vehicle	FMX101 vehicle	FMX101 hydrophobic oil based vehicle (Test Article A) topically applied daily for six weeks on one side of the face (in a split-face model)
Hydro-alcohol solution base	Hydro-alcohol solution	Hydro-alcohol solution based vehicle (Test Article B) topically applied daily for six weeks on the contralateral side of the face (in a split-face model)

Primary Outcome Measures

Name	Time	Method
Number of Participants With 0 to 4 Investigator's Global Assessment Score at Week 6	At Week 6	Severity of acne vulgaris was assessed by Investigator Global Assessment (IGA). The IGA score is a static evaluation of the overall severity or "average" degree of severity of a participant's disease by the Blinded Evaluator taking into account all of the participant's facial acne lesions as the participant appears on the day of the evaluation. Overall severity of acne was assessed using a five-point scale where 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Low score represented best outcome and higher score value indicated worst outcome.
Number of Participants Achieving Investigator's Global Assessments Treatment Success at Week 6	At Week 6	Severity of acne vulgaris was assessed by IGA. The IGA score is a static evaluation of the overall severity or "average" degree of severity of a participant's disease by the Blinded Evaluator taking into account all of the participant's facial acne lesions as the participant appears on the day of the evaluation. Overall severity of acne was assessed using a five-point scale where 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. The IGA treatment "success" was defined as at least a two-point improvement in IGA score relative to Baseline.
Percentage Change From Baseline to Week 6 in Inflammatory Lesion Count	Day 1/ Baseline and Week 6	The ILC included papules (raised inflammatory lesions with no visible purulent material) and pustules (raised inflammatory lesions with visible purulent material).
Absolute Change From Baseline to Week 6 in Inflammatory Lesion Count	Day 1/ Baseline and Week 6	Inflammatory lesion count (ILC) included papules (raised inflammatory lesions with no visible purulent material) and pustules (raised inflammatory lesions with visible purulent material).
Absolute Change From Baseline to Week 6 in Non-Inflammatory Lesion Count	Day 1/ Baseline and Week 6	The non-inflammatory lesion count (NILC) included open and closed comedones.
Percentage Change From Baseline to Week 6 in Non-Inflammatory Lesion Count	Day 1/ Baseline and Week 6	The NILC included open and closed comedones.
Change in Sebum Percentage Relative to Baseline Versus Weeks 2, 4, 6 and 7	Day 1/Baseline and Weeks 2, 4, 6 and 7	Sebum measurement was conducted on the right and left side of the face. The sebum measurement represented the sebum score of saturation of the film and had a range of 0 to 99, where 99 equated to very oily skin.
Change in Transepidermal Water Loss Relative to Baseline Versus Weeks 2, 4, 6 and 7	Day 1/Baseline and Weeks 2, 4, 6 and 7	Transepidermal Water Loss (TEWL) was conducted on the right and left side of the face.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)	Day 1 until Week 7 (End of Study) and Unscheduled Visit	An adverse event is any untoward medical occurrence associated with the use of a drug in participants, whether or not considered drug related.
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline	Day 1 until Week 7 (End of Study) or Unscheduled Visit	The local skin reactions (LSRs) included erythema, edema, scaling/dryness, burning/stinging, pruritus, erosion, and pain) were assessed. Erythema, edema, scaling/dryness, and erosion were assessed by the investigator and burning/stinging, pain, and pruritus were assessed by the participant. Assessments was made using a 4-point ordinal scale where 0=absent, 1=mild (slight, barely perceptible), 2=moderate (distinct presence), and 3=severe (marked, intense). Here, lower point represented no reaction and higher points represented severe reactions.The LSRs were assessed both before and 15 minutes following test article application.

Trial Locations

Locations (1)

Site #01; 🇺🇸 San Diego, California, United States