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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Rosacea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Brimonidine 0.33% gel / CD07805/47 (Br) + Ivermectin 1% cream

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.

Group Type EXPERIMENTAL

Brimonidine 0.33% gel (Br)

Intervention Type DRUG

CD07805/47 (Br) placebo gel

Intervention Type OTHER

Ivermectin 1% cream (IVM)

Intervention Type DRUG

CD07805/47 (Br) placebo gel + 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.

Group Type PLACEBO_COMPARATOR

CD07805/47 (Br) placebo gel

Intervention Type OTHER

CD5024 (IVM) placebo cream

Intervention Type OTHER

Interventions

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Brimonidine 0.33% gel (Br)

Intervention Type DRUG

CD07805/47 (Br) placebo gel

Intervention Type OTHER

Ivermectin 1% cream (IVM)

Intervention Type DRUG

CD5024 (IVM) placebo cream

Intervention Type OTHER

Eligibility Criteria

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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;

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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No