Safety and Efficacy Study of a Topical Minocycline Foam in Patients With Papulopustular Rosacea

Rosacea Clinical Trial

— EMIRA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02601963
• Other study ID #: Study FX2015-10
• Status: Completed
• Phase: Phase 2
• First received: October 19, 2015
• Last updated: February 14, 2017
• Start date: September 2015
• Est. completion date: August 2016

Study information

• Verified date: February 2017
• Source: Foamix Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Papulopustular Rosacea
• Rosacea

Intervention

Drug:
• FMX-103 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.
• FMX-103 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.
• Vehicle foam (0%)
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Foamix Ltd.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the absolute change in inflammatory lesion count at Week 12 compared to Baseline.		Baseline to Week 12
Secondary	The dichotomized Investigator's Global Assessment (IGA) score at Week 12 compared to Baseline		Baseline to Week 12
Secondary	Percent change in inflammatory lesion count at Week 12 compared to Baseline		Baseline to Week 12
Secondary	The dichotomized modified Investigator's Global Assessment (mIGA) score at Week 12 compared to Baseline.		Baseline to Week 12