Phase 3 Papulopustular Rosacea Study - Full Text View

Sponsor:	Galderma
Information provided by (Responsible Party):	Galderma
ClinicalTrials.gov Identifier:	NCT01493687

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.

Resource links provided by NLM:

MedlinePlus related topics: Rosacea

Drug Information available for: Azelaic acid

U.S. FDA Resources

Further study details as provided by Galderma:

Primary Outcome Measures:

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01493687

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Sponsors and Collaborators

Galderma

More Information

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:	April 17, 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 May 23, 2012