Phase 3 Papulopustular Rosacea Study
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Purpose
The purpose of this study is to demonstrate that CD5024 1% cream is more effective than its vehicle when applied once daily, at bed time, during a 12 week period in subjects with Papulopustular Rosacea (PPR) and continues to be safe up to 12 months.
| Condition | Intervention | Phase |
|---|---|---|
|
Papulopustular Rosacea (PPR) |
Drug: CD5024 Drug: Azelaic acid 15% Gel |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase 3 Randomized, Double Blind, 12 Week Vehicle Controlled, Parallel Group Study Assessing the Efficacy and Safety of CD5024 1 % Cream Versus Vehicle Cream in Subjects With Papulopustular Rosacea, Followed by a 40 Week Investigator Blinded Extension Comparing the Long Term Safety of CD5024 1% Cream Versus Azelaic Acid 15 % Gel. |
- Success Rate [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
The percentage of stubjects who achieve "Clear" (Score 0) or "Almost Clear" (Score 1) at Week 12 based on the Investigator Global Assessment (IGA) Score. Evaluation of papulopustular rosacea will be performed by the investigator based on the following 5 point scale.
Clear= 0 No inflammatory lesions present, no erythema Almost Clear= 1 Very few small papules/pustules, very mild erythema present Mild 2= Few small papules/pustules, mild erythema Moderate 3= Several small or large papules/pustules, moderate erythema Severe 4= Numerous small and/or large papules/pustules, severe erythema
- Absolute change in inflammatory lesion count [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]Inflammatory lesion counts will be conducted at each visit by the Investigator or study coordinator.
| Estimated Enrollment: | 681 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CD5024
CD5024 1% Cream
|
Drug: CD5024
CD5024 1% Cream, once daily
|
|
Placebo Comparator: CD5024 Vehicle
CD5024 Vehicle Cream
|
Drug: Azelaic acid 15% Gel
Topical Gel applied twice daily
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- The subject has papulopustular rosacea with an Investigator Global Assessment (IGA) score rated 3 (moderate) or 4 (severe),
- The subject has at least 15 but not more than 70 inflammatory lesions (papules and pustules) on the face.
Exclusion Criteria:
- The subject has particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other facial dermatoses that may be confounded with papulopustular rosacea, such as peri oral dermatitis, facial keratosis pilaris, seborrheic dermatitis, and acne,
- The subject has rosacea with more than two nodules on the face.
Contacts and Locations
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No publications provided
| Responsible Party: | Galderma |
| ClinicalTrials.gov Identifier: | NCT01493687 History of Changes |
| Other Study ID Numbers: | RD.06.SPR.18170 |
| Study First Received: | December 14, 2011 |
| Last Updated: | December 14, 2012 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Additional relevant MeSH terms:
|
Rosacea Skin Diseases Azelaic acid Dermatologic Agents |
Therapeutic Uses Pharmacologic Actions Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 18, 2013