A Study Comparing Two Topicals in the Treatment of Acne Vulgaris

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

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).

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: FMX101 vehicle; Other: Hydro-alcohol solution

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Site #01

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 40 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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)	Drug: FMX101 vehicle; FMX101 vehicle - hydrophobic oil based vehicle (Test Article A); Other Names: Test Article A
EXPERIMENTAL: Hydro-alcohol solution base; 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; Hydro-alcohol solution based vehicle (Test Article B); Other Names: Test Article B

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vyne Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 20, 2018
• Primary Completion (ACTUAL): February 11, 2019
• Study Completion (ACTUAL): February 11, 2019

Study Registration Dates

• First Submitted: November 10, 2018
• First Submitted That Met QC Criteria: November 14, 2018
• First Posted (ACTUAL): November 15, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2021
• Last Update Submitted That Met QC Criteria: March 11, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Anti-Infective Agents; Anti-Bacterial Agents; Minocycline
• Other Study ID Numbers: FX2018-23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No