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A Study Comparing Two Topicals in the Treatment of Acne Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03743038
Recruitment Status : Completed
First Posted : November 15, 2018
Results First Posted : February 23, 2021
Last Update Posted : April 6, 2021
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: FMX101 vehicle Other: Hydro-alcohol solution Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Evaluator-Blinded, Bilateral Comparison Study of Two Topicals in the Treatment of Subjects With Acne Vulgaris
Actual Study Start Date : November 20, 2018
Actual Primary Completion Date : February 11, 2019
Actual Study Completion Date : February 11, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

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 Name: 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 Name: Test Article B




Primary Outcome Measures :
  1. Number of Participants With 0 to 4 Investigator's Global Assessment Score at Week 6 [ Time Frame: 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.

  2. Number of Participants Achieving Investigator's Global Assessments Treatment Success at Week 6 [ Time Frame: 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.

  3. Absolute Change From Baseline to Week 6 in Inflammatory Lesion Count [ Time Frame: 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).

  4. Percentage Change From Baseline to Week 6 in Inflammatory Lesion Count [ Time Frame: 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).

  5. Absolute Change From Baseline to Week 6 in Non-Inflammatory Lesion Count [ Time Frame: Day 1/ Baseline and Week 6 ]
    The non-inflammatory lesion count (NILC) included open and closed comedones.

  6. Percentage Change From Baseline to Week 6 in Non-Inflammatory Lesion Count [ Time Frame: Day 1/ Baseline and Week 6 ]
    The NILC included open and closed comedones.

  7. Change in Sebum Percentage Relative to Baseline Versus Weeks 2, 4, 6 and 7 [ Time Frame: 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.

  8. Change in Transepidermal Water Loss Relative to Baseline Versus Weeks 2, 4, 6 and 7 [ Time Frame: 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.

  9. Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) [ Time Frame: 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.

  10. Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline [ Time Frame: 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.



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Ages Eligible for Study:   12 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03743038


Locations
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United States, California
Site #01
San Diego, California, United States, 92123
Sponsors and Collaborators
Vyne Therapeutics Inc.
  Study Documents (Full-Text)

Documents provided by Vyne Therapeutics Inc.:
Study Protocol  [PDF] November 13, 2018
Statistical Analysis Plan  [PDF] February 7, 2019

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Responsible Party: Vyne Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT03743038    
Other Study ID Numbers: FX2018-23
First Posted: November 15, 2018    Key Record Dates
Results First Posted: February 23, 2021
Last Update Posted: April 6, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents