Overview

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.