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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02601963
Other study ID # Study FX2015-10
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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