Overview

This trial is active, not recruiting.

Conditions rosacea, papulopustular rosacea
Treatments fmx-103 1.5%, fmx-103 3%, vehicle foam (0%)
Phase phase 2
Sponsor Foamix Ltd.
Start date September 2015
End date September 2016
Trial size 233 participants
Trial identifier NCT02601963, Study FX2015-10

Summary

The purpose of this study is to see if the study drug, FMX-103, is safe to give and if it helps people with moderate-to-severe papulopustular rosacea.

The investigational product is FMX-103 minocycline foam. Two concentrations of the investigational product, 1.5% and 3%, will be studied along with vehicle. The foam will be applied once daily to the face for the 12-week treatment duration of the study.

Approximately 210 patients will participate in this study.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
The investigational product is FMX-103 minocycline foam. Two concentrations of the investigational product, 1.5% and 3%, will be studied along with vehicle. The foam will be applied once daily to the face for the 12-week treatment duration of the study.
fmx-103 1.5% Minocycline foam 1.5%
The investigational product is FMX-103 minocycline foam. Two concentrations of the investigational product, 1.5% and 3%, will be studied compared to vehicle in patients with moderate-to-severe papulopustular rosacea. The foam will be applied once daily to the face for the 12-week treatment duration of the study.
(Experimental)
The investigational product is FMX-103 minocycline foam. Two concentrations of the investigational product, 1.5% and 3%, will be studied along with vehicle. The foam will be applied once daily to the face for the 12-week treatment duration of the study.
fmx-103 3% Minocycline foam 3%
The investigational product is FMX-103 minocycline foam. Two concentrations of the investigational product, 1.5% and 3%, will be studied compared to vehicle in patients with moderate-to-severe papulopustular rosacea. The foam will be applied once daily to the face for the 12-week treatment duration of the study.
(Placebo Comparator)
The investigational product is FMX-103 minocycline foam. Two concentrations of the investigational product, 1.5% and 3%, will be studied along with vehicle. The foam will be applied once daily to the face for the 12-week treatment duration of the study.
vehicle foam (0%) Placebo
The investigational product is FMX-103 minocycline foam. Two concentrations of the investigational product, 1.5% and 3%, will be studied compared to vehicle in patients with moderate-to-severe papulopustular rosacea. The foam will be applied once daily to the face for the 12-week treatment duration of the study.

Primary Outcomes

Measure
the absolute change in inflammatory lesion count at Week 12 compared to Baseline.
time frame: Baseline to Week 12

Secondary Outcomes

Measure
The dichotomized Investigator's Global Assessment (IGA) score at Week 12 compared to Baseline
time frame: Baseline to Week 12
Percent change in inflammatory lesion count at Week 12 compared to Baseline
time frame: Baseline to Week 12
The dichotomized modified Investigator's Global Assessment (mIGA) score at Week 12 compared to Baseline.
time frame: Baseline to Week 12

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Participants age is 18 years or older. 2. Participants have a moderate-to-severe rosacea excluding lesions involving the eyes and scalp. 3. Subject must have diagnosed rosacea for at least 6 months prior to screening. Exclusion Criteria: 1. History of hypersensitivity or allergy to minocycline, any other tetracycline or any other component of the formulation such as Soybean oil or Coconut oil. 2. Women of child bearing potential who are pregnant, lactating (in the last 3 months) or planning to become pregnant during the study period. 3. Moderate or severe rhinophyma, dense telangiectasis (score 3, severe), or plaque- like facial edema. 4. Rosacea conglobata or fulminans, corticosteroid-induced rosacea or isolated pustulosis of the chin, facial erythrosis of known origin other than rosacea (e.g., known carcinoid syndrome). 5. Ocular rosacea (e.g., conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical ophthalmic or systemic antibiotics, papulopustular rosacea that requires medically indicated systemic treatment. 6. Bacterial folliculitis.

Additional Information

Official title A Randomized, Multicenter, Double-blind, Vehicle-controlled Study to Evaluate the Safety and Efficacy of Two Different Doses of a Topical Minocycline Foam Compared to Vehicle in the Treatment of Papulopustular Rosacea - Study FX2015-10
Principal investigator Ulrich Mrowietz, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Foamix Ltd..