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

Efficacy and Safety of Ivermectin 1% Topical Cream Associated With Brimonidine 0.33% Topical Gel in the Treatment of Moderate to Severe Rosacea

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 190
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Surrey, British Columbia, Canada
  • Ontario
    • Markham, Ontario, Canada
    • Peterborough, Ontario, Canada
    • Richmond Hill, Ontario, Canada
    • Waterloo, Ontario, Canada
    • Windsor, Ontario, Canada
• United States
  • Arkansas
    • Fort Smith, Arkansas, United States
    • Rogers, Arkansas, United States
  • California
    • Sacramento, California, United States
  • Florida
    • Orlando, Florida, United States
  • Nebraska
    • Omaha, Nebraska, United States
  • New York
    • New York, New York, United States
  • Texas
    • Pflugerville, Texas, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: November 24, 2015
• First Submitted That Met QC Criteria: November 25, 2015
• First Posted (Estimate): November 26, 2015

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Rosacea; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Anti-Infective Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Antiparasitic Agents; Brimonidine Tartrate; Ivermectin
• Other Study ID Numbers: RD.03.SPR.105069