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Completed

NCT Number: NCT01493687

Phase 3 Papulopustular Rosacea Study

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.

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Key information

Conditions

Papulopustular Rosacea (PPR) Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Stratica Medical Inc, Edmonton, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CD5024

Drug

CD5024 1% Cream, once daily

Azelaic acid 15% Gel

Drug

Topical Gel applied twice daily

Primary outcomes

  1. 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)

  2. 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).

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 16, 2011
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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