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

Galderma

Status and phase: Completed; Phase 4

Conditions: Rosacea

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02616250

RD.03.SPR.105069

Details and patient eligibility

About

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.

Enrollment: 190 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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190 participants in 2 patient groups, including a placebo group

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

Experimental group

Description:

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.

Treatment:

Other: CD07805/47 (Br) placebo gel

Drug: Ivermectin 1% cream (IVM)

Drug: Brimonidine 0.33% gel (Br)

CD07805/47 (Br) placebo gel + CD5024 (IVM) placebo cream

Placebo Comparator group

Description:

Subjects will receive once-daily Br vehicle gel in the morning and once-daily IVM vehicle cream in the evening for 12 weeks.

Treatment:

Other: CD5024 (IVM) placebo cream

Other: CD07805/47 (Br) placebo gel