A Study Comparing Two Topicals in the Treatment of Acne Vulgaris

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Evaluator-Blinded, Bilateral Comparison Study of Two Topicals in the Treatment of Subjects With Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: FMX101 vehicle
* Other: Hydro-alcohol solution


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FMX101 vehicle<br>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) | Drug: FMX101 vehicle<br>* FMX101 vehicle - hydrophobic oil based vehicle (Test Article A)<br>* Other names: Test Article A;|
| Experimental: Hydro-alcohol solution base<br>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) | Other: Hydro-alcohol solution<br>* Hydro-alcohol solution based vehicle (Test Article B)<br>* Other names: Test Article B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With 0 to 4 Investigator's Global Assessment Score 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. | At Week 6 | 
| Number of Participants Achieving Investigator's Global Assessments Treatment Success 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. | At Week 6 | 
| Absolute Change From Baseline to Week 6 in Inflammatory Lesion Count | Inflammatory lesion count (ILC) included papules (raised inflammatory lesions with no visible purulent material) and pustules (raised inflammatory lesions with visible purulent material). | Day 1/ Baseline and Week 6 | 
| Percentage Change From Baseline to Week 6 in Inflammatory Lesion Count | The ILC included papules (raised inflammatory lesions with no visible purulent material) and pustules (raised inflammatory lesions with visible purulent material). | Day 1/ Baseline and Week 6 | 
| Absolute Change From Baseline to Week 6 in Non-Inflammatory Lesion Count | The non-inflammatory lesion count (NILC) included open and closed comedones. | Day 1/ Baseline and Week 6 | 
| Percentage Change From Baseline to Week 6 in Non-Inflammatory Lesion Count | The NILC included open and closed comedones. | Day 1/ Baseline and Week 6 | 
| Change in Sebum Percentage Relative to Baseline Versus 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. | Day 1/Baseline and Weeks 2, 4, 6 and 7 | 
| Change in Transepidermal Water Loss Relative to Baseline Versus Weeks 2, 4, 6 and 7 | Transepidermal Water Loss (TEWL) was conducted on the right and left side of the face. | Day 1/Baseline and Weeks 2, 4, 6 and 7 | 
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | An adverse event is any untoward medical occurrence associated with the use of a drug in participants, whether or not considered drug related. | Day 1 until Week 7 (End of Study) and Unscheduled Visit | 
| Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline | 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. | Day 1 until Week 7 (End of Study) or Unscheduled Visit |