Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea

Galderma

Status and phase: Completed; Phase 3

Conditions: Erythema; Rosacea

Treatments: Drug: CD07805/47 gel 0.5%/CD07805/47 Vehicle; Drug: azelaic acid gel 15%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01659853

US10219

Details and patient eligibility

About

The purpose of this study is to compare the efficacy and assess the safety of CD07805/47 gel 0.5% applied topically once daily versus azelaic acid gel 15% applied topically twice daily in subjects with moderate to severe facial erythema of rosacea.

Full description

Adult subjects with moderate to severe facial erythema of rosacea who meet inclusion/exclusion criteria will be randomized at Baseline/Visit 1 in a 1:1 ratio to receive either CD07805/47 gel 0.5% once daily or azelaic acid gel 15% twice daily for 15 days. Following an appropriate washout period, subjects will then switch treatments and use the second investigational product as instructed for 15 days (according to the subject's randomization scheme). Subjects will re-qualify based upon inclusion/exclusion prior to Period 2 treatment.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject is male or female aged 18 years or older.
2. Subject has a clinical diagnosis of facial rosacea.
3. Subject has a clinician's assessment score of moderate to severe erythema prior to enrollment.
4. Subject has a self assessment score of moderate to severe redness prior to enrollment.
5. Subjects with none to mild facial inflammatory lesions of rosacea prior to enrollment.

Exclusion criteria

1. Female subjects who are pregnant, nursing or planning a pregnancy during the study.
2. Subjects with a condition or who are in a situation, which in the Investigator's opinion may put a subject at risk, may confound study results, or may interfere with a subject's participation in the study.
3. Subjects with conditions causing facial erythema which would confound the assessment of treatment.
4. Subjects who are taking or have recently taken medications known to have interactions with α2-adrenergic agonists.
5. Subjects with known allergies or sensitivities to one of the components of the investigational products.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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70 participants in 1 patient group

Overall Study

Experimental group

Description:

In this crossover study of CD07805/47 gel 0.5%/CD07805/47 Vehicle and azelaic acid gel 15%, 70 subjects were randomly assigned to treatment sequence. During Period 1 (15 days), 35 subjects received topical CD07805/47 gel 0.5% in the morning and topical CD07805/47 gel vehicle in the evening, and 35 received topical azelaic acid gel twice daily according to FDA approved prescribing information. Subjects crossed over to the other treatment in Period 2 (15 days).

Treatment:

Drug: azelaic acid gel 15%

Drug: CD07805/47 gel 0.5%/CD07805/47 Vehicle