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A Study Comparing Two Topicals in the Treatment of Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT03743038
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
Foamix Ltd.

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 treatent with Test Article A to one side of the face versus Test Article B on the contralateral side.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 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 19, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : May 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. IGA Assessment [ Time Frame: 6 weeks ]
    Severity of acne vulgaris assessed by investigator Global Assessment (IGA) Treatment A> Treatment B, Treatment A= Treatment B, Treatment A< Treatment B

  2. Inflammatory Lesion Count [ Time Frame: 6 weeks ]
    The absolute change from baseline in the inflammatory lesion count at week 6

  3. Non-inflammatory Lesion Count [ Time Frame: 6 weeks ]
    The absolute change from baseline in the non inflammatory lesion count at week 6

  4. Sebum assessment [ Time Frame: 2, 4, 6 and 7 weeks ]
    Sebum assessment relative to Baseline versus Weeks 2, 4, 6, and 7, within subject Treatment A versus Treatment B

  5. Inflammatory Lesion Count [ Time Frame: 6 weeks ]
    The percent change from baseline in the inflammatory lesion count at week 6

  6. Non-inflammatory Lesion Count [ Time Frame: 6 weeks ]
    The percent change from baseline in the non inflammatory lesion count at week 6

  7. Trans Epidermal Water Loss (TEWL) assessment [ Time Frame: 2, 4, 6 and 7 weeks ]
    TEWL assessment relative to Baseline versus Weeks 2, 4, 6, and 7,



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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


Contacts
Contact: Therapeutics Inc. 858.571.1800 clinicalresearch@therapeuticsinc.com

Locations
United States, California
Site #01 Recruiting
San Diego, California, United States, 92123
Sponsors and Collaborators
Foamix Ltd.

Responsible Party: Foamix Ltd.
ClinicalTrials.gov Identifier: NCT03743038     History of Changes
Other Study ID Numbers: FX2018-23
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Pharmaceutical Solutions
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs