Clinical trial NCT03743038: A Study Comparing Two Topicals in the Treatment of Acne Vulgaris
Official title: A Randomized, Evaluator-Blinded, Bilateral Comparison Study of Two Topicals in the Treatment of Subjects With Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acne Vulgaris
Lead sponsor: Vyne Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2018-11-15
Enrollment: 12
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With 0 to 4 Investigator's Global Assessment Score at Week 6
timeFrame: At Week 6
measure: Number of Participants Achieving Investigator's Global Assessments Treatment Success at Week 6
timeFrame: At Week 6
measure: Absolute Change From Baseline to Week 6 in Inflammatory Lesion Count
timeFrame: Day 1/ Baseline and Week 6
measure: Percentage Change From Baseline to Week 6 in Inflammatory Lesion Count
timeFrame: Day 1/ Baseline and Week 6
measure: Absolute Change From Baseline to Week 6 in Non-Inflammatory Lesion Count
timeFrame: Day 1/ Baseline and Week 6
measure: Percentage Change From Baseline to Week 6 in Non-Inflammatory Lesion Count
timeFrame: Day 1/ Baseline and Week 6
measure: Change in Sebum Percentage Relative to Baseline Versus Weeks 2, 4, 6 and 7
timeFrame: Day 1/Baseline and Weeks 2, 4, 6 and 7
measure: Change in Transepidermal Water Loss Relative to Baseline Versus Weeks 2, 4, 6 and 7
timeFrame: Day 1/Baseline and Weeks 2, 4, 6 and 7
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
timeFrame: Day 1 until Week 7 (End of Study) and Unscheduled Visit
measure: Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline
timeFrame: Day 1 until Week 7 (End of Study) or Unscheduled Visit
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Site #01
state: California
Study officials:
References: