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Trial record 1 of 1 for:    NCT03142451
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A Study (Study 1) to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam in the Treatment of Facial Papulopustular Rosacea

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ClinicalTrials.gov Identifier: NCT03142451
Recruitment Status : Completed
First Posted : May 5, 2017
Results First Posted : December 17, 2020
Last Update Posted : January 29, 2021
Sponsor:
Collaborator:
Premier Research Group plc
Information provided by (Responsible Party):
Vyne Therapeutics Inc.

Brief Summary:
The primary objectives of this study are to determine the efficacy and safety of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea.

Condition or disease Intervention/treatment Phase
Facial Papulopustular Rosacea Drug: FMX103 minocycline foam 1.5% 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 of FMX103 topical foam containing 1.5% minocycline compared to vehicle, in the treatment of participants with moderate-to-severe facial papulopustular rosacea. Qualified participants will be randomized in a 2:1 ratio (active:vehicle) to receive 1 of the following 2 treatments:

  • FMX103 minocycline foam 1.5%
  • Vehicle foam

Participants will be assigned to 1 of 2 treatments according to the randomization schedule. Participants will apply (or have applied) the study drug topically once daily for 12 weeks as directed. Participants will be advised to use the study drug at approximately the same time each day. Both the Investigator and participant will be blinded to the study drug identity. Participants will return for visits at Weeks 1, 4, 6, 8, 10, and 12. Efficacy evaluations (inflammatory lesion counts and Investigator's Global Assessment [IGA] score) will be performed at Weeks 4, 8, and 12 during the study.

Note: Originally the two studies FX2016-11 and FX2016-12 were combinedly presented in the protocol registration form under one NCT number (NCT03142451), and later separated since results were analyzed separately.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 751 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: This is a double-blind study, with limited access to the randomization code. The randomization code will be held in confidence until after the study database is locked and a memo documenting the database lock has been issued. Every effort will be made to retain the integrity of the blind. When issued to the sites, the study drug will be identical in appearance for all participants, regardless of treatment assignment.
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Double-blind, Vehicle-controlled Study to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam Compared to Vehicle in the Treatment of Facial Papulopustular Rosacea (FX2016-11)
Actual Study Start Date : June 2, 2017
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : September 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Rosacea
MedlinePlus related topics: Rosacea

Arm Intervention/treatment
Experimental: FMX103 1.5%
Participants will apply the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.
Drug: FMX103 minocycline foam 1.5%
Dosage form description: Foam containing minocycline HCl 1.5%. Once daily application of a sufficient amount of foam to cover the entire face. Estimated maximum is 0.5 g of drug product containing 7.5 mg (1.5% active) of minocycline. Participants will apply a small amount of the drug as a thin layer over all areas of the face. Participants should apply the drug at approximately the same time each day, about 1 hour before bedtime.

Placebo Comparator: Vehicle foam
Participants will apply the assigned vehicle foam topically once daily for 12 weeks as directed.
Drug: Vehicle foam
Dosage form description: Foam containing minocycline vehicle foam. Once daily application of a sufficient amount of foam to cover the entire face. Estimated maximum is 0.5 g of drug product containing 0.0 mg (vehicle) of minocycline. Participants will apply a small amount of the drug as a thin layer over all areas of the face. Participants should apply the drug at approximately the same time each day, about 1 hour before bedtime.




Primary Outcome Measures :
  1. The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Count at Week 12 [ Time Frame: Baseline and Week 12 ]

    To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. Lesion counts included the number of papules, pustules, and nodules.

    Change from Baseline was calculated as the value at Baseline minus the post-Baseline value. Thus, a positive change reflects a reduction in lesion count.


  2. Percentage of Participants Achieving Investigator Global Assessments (IGA) Treatment Success at Week 12 [ Time Frame: Week 12 ]
    To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. The Investigator assessed the global severity of rosacea using the IGA scale. The scale ranges from 0 (Clear): No inflammatory papules or pustules to 4 (Severe): Many inflammatory papules or pustules, and up to 2 nodules. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (clear) or 1 (almost clear), and at least a 2-step improvement (decrease) from Day 0/Baseline.


Secondary Outcome Measures :
  1. Percentage of Participants Achieving IGA Treatment Success of at Least 2 Grades at Week 12 [ Time Frame: Week 12 ]

    To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. The Investigator assessed the global severity of rosacea using the IGA scale. The scale ranges from 0 (Clear): No inflammatory papules or pustules to 4 (Severe): Many inflammatory papules or pustules, and up to 2 nodules. Higher scores indicated severe outcome. Treatment success was defined as a 2-grade improvement (decrease) in score at Week 12 compared to Day 0/Baseline.

    Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.


  2. The Percent Change From Day 0/Baseline in Inflammatory Lesion Count at Week 12 [ Time Frame: Baseline and Week 12 ]

    To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. Lesion counts included the number of papules, pustules, and nodules.

    Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.


  3. The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Counts at Week 4 and Week 8 [ Time Frame: Baseline, Week 4 and Week 8 ]
    To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. Lesion counts included the number of papules, pustules, and nodules. The change from Baseline was calculated as the value at Baseline minus the post-Baseline value. Thus, a positive change reflects a reduction in lesion count.

  4. Percentage of Participants Achieving IGA Treatment Success at Week 4 and Week 8 [ Time Frame: Week 4 and Week 8 ]
    To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. The Investigator assessed the global severity of rosacea using the IGA scale. The scale ranges from 0 (Clear): No inflammatory papules or pustules to 4 (Severe): Many inflammatory papules or pustules, and up to 2 nodules. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (clear) or 1 (almost clear), and at least a 2-grade improvement (decrease) from Day 0/Baseline.

  5. Number of Participants With Adverse Events (AEs) [ Time Frame: From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit]) ]
    To evaluate the tolerability and safety of topical minocycline foam applied once daily for 12 weeks. A treatment-emergent adverse events (TEAE) was defined as any AE with an onset date on or after the first application of study drug, and before to the last application of study drug plus 3 days, having been absent pre-treatment or worsening relative to the pre-treatment state.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Moderate-to-severe rosacea (as per the IGA score) on the proposed facial treatment area consisting of:

    1. At least 15 and not more than 75 facial papules and pustules, excluding lesions involving the eyes and scalp;
    2. No more than 2 nodules on the face.
  2. Presence of or history of erythema and/or flushing on the face.

Exclusion Criteria:

  1. Presence of any skin condition and/or Excessive facial hair, on the face that would interfere with the diagnosis or assessment of rosacea.
  2. Moderate or severe rhinophyma, dense telangiectasia (score 3, severe), or plaque-like facial edema.
  3. History of hypersensitivity or allergy to minocycline, any other tetracycline, or of any other component of the formulation.
  4. Active ocular rosacea (eg, conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.

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): NCT03142451


Locations
Show Show 54 study locations
Sponsors and Collaborators
Vyne Therapeutics Inc.
Premier Research Group plc
  Study Documents (Full-Text)

Documents provided by Vyne Therapeutics Inc.:
Study Protocol  [PDF] May 12, 2017
Statistical Analysis Plan  [PDF] July 31, 2018

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Responsible Party: Vyne Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT03142451    
Other Study ID Numbers: FX2016-11
First Posted: May 5, 2017    Key Record Dates
Results First Posted: December 17, 2020
Last Update Posted: January 29, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Vyne Therapeutics Inc.:
Topical Minocycline Foam
2-Arm study
Inflammatory lesion counts
Investigator's Global Assessment score
Additional relevant MeSH terms:
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Rosacea
Facies
Disease Attributes
Pathologic Processes
Skin Diseases
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents