MirvasO Soolantra Association In the Treatment of Moderate to Severe rosaCea.

Phase 4

Completed

• Conditions: Rosacea
• Interventions: Drug: Brimonidine 0.33% gel (Br); Other: CD07805/47 (Br) placebo gel; Other: CD5024 (IVM) placebo cream; Drug: Ivermectin 1% cream (IVM)

• Registration Number: NCT02616250
• Lead Sponsor: Galderma R&D

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-24
• Study First Submitted QC: 2015-11-25
• Study First Posted: 2015-11-26
• Study Start: 2015-12
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Results First Submitted: 2017-09-19
• Results First Submitted QC: 2017-09-19
• Results First Posted: 2017-10-19
• Status Verified: 2018-02
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brimonidine 0.33% gel / CD07805/47 (Br) + Ivermectin 1% cream	CD07805/47 (Br) placebo gel	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.
CD07805/47 (Br) placebo gel + CD5024 (IVM) placebo cream	CD07805/47 (Br) placebo gel	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	CD5024 (IVM) placebo cream	Subjects will receive once-daily Br vehicle gel in the morning and once-daily IVM vehicle cream in the evening for 12 weeks.
Brimonidine 0.33% gel / CD07805/47 (Br) + Ivermectin 1% cream	Ivermectin 1% cream (IVM)	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 / CD07805/47 (Br) + Ivermectin 1% cream	Brimonidine 0.33% gel (Br)	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.

Primary Outcome Measures

Name	Time	Method
Efficacy Variable: Percentage of Patients Defined as Success on the Global Rosacea Severity Grading Scale Called Investigator's Global Assessment (IGA):	week 12/Hour 3	Percentage of patients defined as success as per scores of IGA; ie: clear (score=0) or almost clear (score=1)