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| Sponsor: | Foamix Ltd. |
|---|---|
| Information provided by (Responsible Party): | Foamix Ltd. |
| ClinicalTrials.gov Identifier: | NCT01134991 |
Purpose
Acne rosacea is a chronic acneiform disorder affecting both the skin and the eye. It is a syndrome of undetermined etiology characterized by both vascular and papulopustular components involving the face and occasionally the neck and upper trunk.
This is a pilot phase II study to evaluate the tolerability and safety and to monitor the clinical efficacy of Topical Minocycline Foam FXFM244 in moderate to severe Rosacea patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Rosacea |
Drug: Topical Minocycline Foam FXFM244 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Pilot, Randomized, Double Blind, Placebo Controlled, Parallel Group, Dose Range Finding Study, to Evaluate the Tolerability and Safety of FXFM244 Antibiotic Foam and to Monitor Its Clinical Effect in Moderate to Severe Rosacea Patients |
| Estimated Enrollment: | 45 |
| Study Start Date: | June 2010 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Topical Minocycline Foam FXFM244 Placebo |
Drug: Topical Minocycline Foam FXFM244
FXFM244 - 1%, FXFM244 - 4% or Placebo to be applied twice daily during 12 weeks
|
| Experimental: Topical Minocycline Foam FXFM244, 1% |
Drug: Topical Minocycline Foam FXFM244
FXFM244 - 1%, FXFM244 - 4% or Placebo to be applied twice daily during 12 weeks
|
| Experimental: Topical Minocycline Foam FXFM244, 4% |
Drug: Topical Minocycline Foam FXFM244
FXFM244 - 1%, FXFM244 - 4% or Placebo to be applied twice daily during 12 weeks
|
A Pilot, Randomized, Double Blind, Placebo Controlled, Parallel Group, Dose Range Finding Study. The study will involve three treatment groups. Eligible patients will be randomized to receive either FXFM244 - 1%, FXFM244 - 4% or Placebo, in a blinded fashion. Patients will be treated twice daily for 12 weeks. Following the screening period and baseline visit, study subjects will return at Weeks 3, 6, 9 and 12. A follow up visit will take place at week 16. At each visit, patients will be evaluated via lesion count, global assessment tolerability and safety.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with clinical diagnosis of moderate to severe facial rosacea as determined by:
Exclusion Criteria:
Concomitant medication:
Contacts and Locations| Israel | |
| Sourasky Medical Center | Recruiting |
| Tel-Aviv, Israel | |
| Contact: Eli Sprecher, MD +972-3-6974479 | |
| Contact: Dvora Yashar +972-3-6974998 | |
| Principal Investigator: Eli Sprecher, MD | |
More Information
| Responsible Party: | Foamix Ltd. |
| ClinicalTrials.gov Identifier: | NCT01134991 History of Changes |
| Other Study ID Numbers: | 0041-10LND /FX2010-02 |
| Study First Received: | May 26, 2010 |
| Last Updated: | April 25, 2012 |
| Health Authority: | Israel: Institutional Review Board - Laniado Hospital |
|
rosacea topical minocycline foam phase II |
|
Rosacea Skin Diseases Minocycline Anti-Bacterial Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |