Back to resultsA Study Comparing Two Topicals in the Treatment of Acne Vulgaris
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
FMX101 vehicle
Hydro-alcohol solution
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris
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
Sites / Locations
- Site #01
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
FMX101 vehicle
Hydro-alcohol solution base
Arm Description
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 based vehicle (Test Article B) topically applied daily for six weeks on the contralateral side of the face (in a split-face model)
Outcomes
Primary Outcome Measures
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.
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.
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).
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).
Absolute Change From Baseline to Week 6 in Non-Inflammatory Lesion Count
The non-inflammatory lesion count (NILC) included open and closed comedones.
Percentage Change From Baseline to Week 6 in Non-Inflammatory Lesion Count
The NILC included open and closed comedones.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03743038
First Posted
November 10, 2018
Last Updated
March 11, 2021
Sponsor
Vyne Therapeutics Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03743038
Brief Title
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
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 20, 2018 (Actual)
Primary Completion Date
February 11, 2019 (Actual)
Study Completion Date
February 11, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vyne Therapeutics Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FMX101 vehicle
Arm Type
Experimental
Arm Description
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)
Arm Title
Hydro-alcohol solution base
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
FMX101 vehicle
Other Intervention Name(s)
Test Article A
Intervention Description
FMX101 vehicle - hydrophobic oil based vehicle (Test Article A)
Intervention Type
Other
Intervention Name(s)
Hydro-alcohol solution
Other Intervention Name(s)
Test Article B
Intervention Description
Hydro-alcohol solution based vehicle (Test Article B)
Primary Outcome Measure Information:
Title
Number of Participants With 0 to 4 Investigator's Global Assessment Score at Week 6
Description
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.
Time Frame
At Week 6
Title
Number of Participants Achieving Investigator's Global Assessments Treatment Success at Week 6
Description
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.
Time Frame
At Week 6
Title
Absolute Change From Baseline to Week 6 in Inflammatory Lesion Count
Description
Inflammatory lesion count (ILC) included papules (raised inflammatory lesions with no visible purulent material) and pustules (raised inflammatory lesions with visible purulent material).
Time Frame
Day 1/ Baseline and Week 6
Title
Percentage Change From Baseline to Week 6 in Inflammatory Lesion Count
Description
The ILC included papules (raised inflammatory lesions with no visible purulent material) and pustules (raised inflammatory lesions with visible purulent material).
Time Frame
Day 1/ Baseline and Week 6
Title
Absolute Change From Baseline to Week 6 in Non-Inflammatory Lesion Count
Description
The non-inflammatory lesion count (NILC) included open and closed comedones.
Time Frame
Day 1/ Baseline and Week 6
Title
Percentage Change From Baseline to Week 6 in Non-Inflammatory Lesion Count
Description
The NILC included open and closed comedones.
Time Frame
Day 1/ Baseline and Week 6
Title
Change in Sebum Percentage Relative to Baseline Versus Weeks 2, 4, 6 and 7
Description
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.
Time Frame
Day 1/Baseline and Weeks 2, 4, 6 and 7
Title
Change in Transepidermal Water Loss Relative to Baseline Versus Weeks 2, 4, 6 and 7
Description
Transepidermal Water Loss (TEWL) was conducted on the right and left side of the face.
Time Frame
Day 1/Baseline and Weeks 2, 4, 6 and 7
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Description
An adverse event is any untoward medical occurrence associated with the use of a drug in participants, whether or not considered drug related.
Time Frame
Day 1 until Week 7 (End of Study) and Unscheduled Visit
Title
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline
Description
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.
Time Frame
Day 1 until Week 7 (End of Study) or Unscheduled Visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Site #01
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study Comparing Two Topicals in the Treatment of Acne Vulgaris
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