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A Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 in the Treatment of Moderate-to-Severe Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT03271021
Recruitment Status : Completed
First Posted : September 1, 2017
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
Foamix Ltd.

Brief Summary:
A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 for 12 Weeks in the Treatment of Moderate-to-Severe Acne Vulgaris (Study FX2017-22)

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: FMX101 Drug: Vehicle Foam Phase 3

Detailed Description:

This is a randomized, multicenter, double-blind, vehicle-controlled, 2 arm study to evaluate the safety and efficacy over 12 weeks of FMX101 topical foam containing 4% minocycline compared to vehicle in the treatment of subjects with moderate-to-severe facial acne vulgaris. Qualified subjects will be randomized to receive 1 of the following 2 treatments:

  • FMX101 4% minocycline foam
  • Vehicle foam

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1507 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 for 12 Weeks in the Treatment of Moderate-to-Severe Acne Vulgaris (Study FX2017-22)
Actual Study Start Date : July 17, 2017
Actual Primary Completion Date : September 4, 2018
Actual Study Completion Date : September 4, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
Drug Information available for: Minocycline

Arm Intervention/treatment
Experimental: FMX101, 4% minocycline foam
FMX101, 4% minocycline foam applied topically once daily for 12 weeks
Drug: FMX101
FMX101, 4% minocycline foam

Placebo Comparator: Vehicle foam
Vehicle foam applied topically once daily for 12 weeks
Drug: Vehicle Foam
Vehicle Foam




Primary Outcome Measures :
  1. The absolute change from Baseline in the inflammatory lesion count at Week 12. [ Time Frame: 12 weeks ]
  2. Severity of acne vulgaris assessed by Investigator Global Assessment (IGA) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Absolute Change from baseline in the inflammatory lesion count [ Time Frame: 6 weeks ]
  2. Absolute Change from baseline in IGA evaluation [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Has facial acne vulgaris with:

    1. 20 to 50 inflammatory lesions (papules, pustules, and nodules)
    2. 25 to 100 non-inflammatory lesions (open and closed comedones)
    3. No more than 2 nodules on the face
    4. IGA score of moderate (3) to severe (4)
  2. Willing to use only the supplied non-medicated cleanser (Cetaphil Gentle Skin Cleanser) and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study.

Exclusion Criteria:

  1. 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.
  2. 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): NCT03271021


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Sponsors and Collaborators
Foamix Ltd.

Additional Information:
Responsible Party: Foamix Ltd.
ClinicalTrials.gov Identifier: NCT03271021     History of Changes
Other Study ID Numbers: FX2017-22
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 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
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents