Overview

This trial is active, not recruiting.

Condition rosacea
Treatments brimonidine 0.33% gel (br), cd07805/47 (br) placebo gel, ivermectin 1% cream (ivm), cd5024 (ivm) placebo cream
Phase phase 4
Sponsor Galderma
Start date December 2015
End date June 2016
Trial size 188 participants
Trial identifier NCT02616250, RD.03.SPR.105069

Summary

The main objective of this study is to evaluate the efficacy of Ivermectin 1% cream (IVM) associated with Brimonidine 0.33% gel (Br) compared with the association of their respective vehicles in the treatment of moderate to severe rosacea.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Half group will receive once-daily Br 0.33% gel in the morning and once-daily IVM 1% cream in the evening for 12 weeks. Half group will receive once-daily Br vehicle gel in the morning for the first 4 weeks and once-daily Br 0.33% gel in the morning for the following 8 weeks and once-daily IVM 1% cream in the evening for 12 weeks.
brimonidine 0.33% gel (br)
cd07805/47 (br) placebo gel
ivermectin 1% cream (ivm)
(Placebo Comparator)
Subjects will receive once-daily Br vehicle gel in the morning and once-daily IVM vehicle cream in the evening for 12 weeks.
cd07805/47 (br) placebo gel
cd5024 (ivm) placebo cream

Primary Outcomes

Measure
Efficacy variable: Percentage of patients across the 5 scores of the global rosacea severity grading scale called Investigator's Global Assessment (IGA).
time frame: week 12

Eligibility Criteria

Male or female participants at least 18 years old.

Main Inclusion Criteria: 1. Male or female subjects age 18 years or older; 2. Subjects with a minimum of 15 but not more than 70 inflammatory lesions (papules and pustules) of rosacea on the face; 3. Subjects with moderate or severe diffuse persistent facial erythema of rosacea (scored 3 or 4 according to Clinician's Erythema Assessment [CEA]); 4. Subjects with moderate or severe papulopustular rosacea (scored 3 or 4 according to the Investigator's Global Assessment [IGA]); 5. Female subjects of childbearing potential with a negative urine pregnancy test (UPT); 6. Female subjects of childbearing potential must practice a highly effective method of contraception during the study; 7. Females subjects of non-childbearing potential; Main Exclusion Criteria: 1. Subjects with particular forms of rosacea or other concomitant facial dermatoses that may be confounded with rosacea; 2. Subjects with more than 2 nodules of rosacea on the face; 3. Subjects with any uncontrolled chronic or serious disease or medical condition that may either interfere with the interpretation of the clinical trial results, or with optimal participation in the study or would present a significant risk to the subject; 4. Subjects with known or suspected allergies or sensitivities to any component of the investigational and non-investigational products, including the active ingredients brimonidine or salts of brimonidine like brimonidine tartrate and ivermectin;

Additional Information

Official title Efficacy and Safety of Ivermectin 1% Topical Cream Associated With Brimonidine 0.33% Topical Gel in the Treatment of Moderate to Severe Rosacea
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Galderma.