Phase 3 Papulopustular Rosacea Study

• CD5024 (Drug): CD5024 1% Cream, once daily
• Azelaic acid 15% Gel (Drug): Topical Gel applied twice daily

Primary outcomes

• Success Rate [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 [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

• Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF) [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).

Sex: All, ages: 18 Years to any

Inclusion Criteria:

1. The subject has papulopustular rosacea with an Investigator Global Assessment (IGA) score rated 3 (moderate) or 4 (severe),
2. The subject has at least 15 but not more than 70 inflammatory lesions (papules and pustules) on the face.

Exclusion Criteria:

1. 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,
2. The subject has rosacea with more than two nodules on the face.

Participant flow

Outcome results

• Success Rate (Primary), Number, Percentage of participants: CD5024 1% Cream 38.4; CD5024 Vehicle Cream 11.6 (p <0.001)
• Absolute Change in Inflammatory Lesion Count (Primary), Mean, Lesion count change: CD5024 1% Cream -20.5 +/- 15.95; CD5024 Vehicle Cream -12.0 +/- 13.55 (p <0.001)
• Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF) (Secondary), Mean, Percentage of change in lesion counts: CD5024 1% Cream -64.9 +/- 39.91; CD5024 Vehicle Cream -41.6 +/- 38.83 (p <0.001)

Adverse events

Time frame: Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.

Serious adverse events by term

Other adverse events by term

• Michael Graeber, M.D., Study director, Galderma R&D, LLC