A Study (Study 2) to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam in the Treatment of Facial Papulopustular Rosacea

Browse trials for

• Rosacea 225
• Facies 218

Keywords

• Topical Minocycline Foam
• 2-Arm study
• Inflammatory lesion counts
• Investigator's Global Assessment score

Rosacea

225 studies on the registry are indexed under Rosacea; 19 are open to participants now.

This study's enrollment of 771 is above the median of 61 across 195 interventional studies indexed under Rosacea.

Lead sponsor

Vyne Therapeutics Inc. is the lead sponsor of 32 studies on the registry; none are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 13 (59%) have results posted.

Study arms

• 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%

• Placebo comparator
  Vehicle foam

  Participants will apply the assigned vehicle foam topically once daily for 12 weeks as directed.

  Drug: Vehicle foam

Interventions

• DrugFMX103 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.

• DrugVehicle 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 outcomes

1. The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Count at 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.

   Time frame: Baseline and Week 12

2. Percentage of Participants Achieving Investigator Global Assessments (IGA) Treatment Success at 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.

   Time frame: Week 12

Secondary outcomes

1. Percentage of Participants Achieving IGA Treatment Success of at Least 2 Grades at 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.

   Time frame: Week 12

2. The Percent Change From Day 0/Baseline in Inflammatory Lesion Count at 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.

   Time frame: Baseline and Week 12

3. The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Counts at 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. 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.

   Time frame: Baseline, Week 4 and Week 8

4. Percentage of Participants Achieving IGA Treatment Success at 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.

   Time frame: Week 4 and Week 8

5. Number of Participants With Adverse Events (AEs)

   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.

   Time frame: From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])

Baseline characteristics

Study documents

• Study protocol · May 12, 2017
• Statistical analysis plan · Jul 9, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No