Rosacea Clinical Trial
— EMIRAOfficial 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
Verified date | February 2017 |
Source | Foamix Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Foamix Ltd. |
Germany,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05597462 -
Impact of DFD-29 on Microbial Flora of Healthy, Adult Human Subjects When Administered Over 16 Weeks
|
Phase 1 | |
Completed |
NCT02249065 -
Mirvaso in Use Study
|
Phase 4 | |
Completed |
NCT02292797 -
Assessment of the Rosacea Prevalence in the General Population
|
N/A | |
Completed |
NCT01659853 -
Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea
|
Phase 3 | |
Completed |
NCT01426269 -
Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea® vs Placebo
|
Phase 4 | |
Completed |
NCT00991198 -
The Role of Topically Dissolved Oxygen (TDO) to Ameliorate Signs of Photodamage
|
Phase 2 | |
Terminated |
NCT04336163 -
Skin Imaging to Inform Laser Treatments
|
N/A | |
Recruiting |
NCT04108897 -
Analysis of the Microbiome in Rosacea
|
Early Phase 1 | |
Completed |
NCT03872050 -
Deep Phenotyping of Rosacea and Migraine
|
||
Active, not recruiting |
NCT06033352 -
Potassium-titanyl Phosphate (KTP) Laser vs KTP Laser and Ivermectin Cream for Facial Rosacea
|
Phase 2 | |
Completed |
NCT03263273 -
Study to Evaluate the Safety and Efficacy of Topical Minocycline Gel in Patients With Papulopustular Rosacea
|
Phase 2 | |
Completed |
NCT04508660 -
CGB-400 for the Reduction of Facial Redness
|
Phase 1 | |
Completed |
NCT04508205 -
CGB-400 for the Reduction of Facial Redness and Bumps and Blemishes
|
Phase 1 | |
Completed |
NCT05094700 -
A Study of a Polymeric Surfactant Technology Cleanser in Sensitive Skin Participants
|
N/A | |
Active, not recruiting |
NCT03211585 -
EVALUATION OF THE EFFECT OF THE PERFECTA V-BEAM LASER ON ROSACEA
|
N/A | |
Completed |
NCT02576860 -
Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle
|
Phase 3 | |
Completed |
NCT02576847 -
Study to Evaluate the Long-term Safety of a Once-Daily Omiganan Topical Gel
|
Phase 3 | |
Completed |
NCT02637232 -
Mirvaso® Utilisation and Patient Satisfaction Evaluation (MUSE)
|
||
Completed |
NCT02583009 -
A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Rosacea
|
Phase 2 | |
Completed |
NCT01993446 -
A Safety and Efficacy Study of DRM02 in Subjects With Rosacea
|
Phase 2 |