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

• ClinicalTrials.gov Identifier: NCT02616250
• Recruitment Status: Completed
• First Posted: November 26, 2015
• Results First Posted: October 19, 2017
• Last Update Posted: February 18, 2021
• Sponsor: Galderma R&D
• Information provided by (Responsible Party): Galderma R&D

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Rosacea	Drug: Brimonidine 0.33% gel (Br); Other: CD07805/47 (Br) placebo gel; Drug: Ivermectin 1% cream (IVM); Other: CD5024 (IVM) placebo cream	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 190 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: December 2015
• Actual Primary Completion Date: September 2016
• Actual Study Completion Date: September 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: Brimonidine 0.33% gel (Br); Other: CD07805/47 (Br) placebo gel; Drug: Ivermectin 1% cream (IVM)
Placebo Comparator: 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.	Other: CD07805/47 (Br) placebo gel; Other: CD5024 (IVM) placebo cream

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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;

Contacts and Locations

Locations

United States, Arkansas

Fort Smith, Arkansas, United States

Rogers, Arkansas, United States

United States, California

Sacramento, California, United States

United States, Florida

Orlando, Florida, United States

United States, Nebraska

Omaha, Nebraska, United States

United States, New York

New York, New York, United States

United States, Texas

Pflugerville, Texas, United States

Canada, British Columbia

Surrey, British Columbia, Canada

Canada, Ontario

Markham, Ontario, Canada

Peterborough, Ontario, Canada

Richmond Hill, Ontario, Canada

Waterloo, Ontario, Canada

Windsor, Ontario, Canada

Sponsors and Collaborators

Galderma R&D

More Information

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT02616250
• Other Study ID Numbers: RD.03.SPR.105069
• First Posted: November 26, 2015
• Results First Posted: October 19, 2017
• Last Update Posted: February 18, 2021
• Last Verified: February 2018

Additional relevant MeSH terms:

Rosacea; Skin Diseases; Ivermectin; Brimonidine Tartrate; Antiparasitic Agents; Anti-Infective Agents; Antihypertensive Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs