Phase 3 Papulopustular Rosacea Study
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|ClinicalTrials.gov Identifier: NCT01493687|
Recruitment Status : Completed
First Posted : December 16, 2011
Results First Posted : January 16, 2015
Last Update Posted : February 18, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Papulopustular Rosacea (PPR)||Drug: CD5024 Drug: Azelaic acid 15% Gel||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||683 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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.|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||August 2013|
CD5024 1% Cream
CD5024 1% Cream, once daily
Placebo Comparator: CD5024 Vehicle
CD5024 Vehicle Cream
Drug: Azelaic acid 15% Gel
Topical Gel applied twice daily
- Success Rate [ Time Frame: Week 12 ]
Percentage of subjects who achieve "Clear" (Score 0) or "Almost Clear" (Score 1) at Week 12 (ITT-LOCF) 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 ]Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).
- Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF) [ Time Frame: Baseline to Week 12 ]Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01493687
|Study Director:||Michael Graeber, M.D.||Galderma R&D, LLC|
|Responsible Party:||Galderma R&D|
|Other Study ID Numbers:||
|First Posted:||December 16, 2011 Key Record Dates|
|Results First Posted:||January 16, 2015|
|Last Update Posted:||February 18, 2021|
|Last Verified:||January 2015|