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

• Status: Completed
• Trial end date: 2018-09-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Foamix Ltd.; Vyne Therapeutics Inc.
• Collaborator: Premier Research Group plc
• Treatments: Minocycline

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.