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Completed

NCT Number: NCT02616250

MirvasO Soolantra Association 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.

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Key information

Conditions

Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Surrey, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main Inclusion Criteria:

  • Male or female subjects age 18 years or older;
  • Subjects with a minimum of 15 but not more than 70 inflammatory lesions (papules and pustules) of rosacea on the face;
  • Subjects with moderate or severe diffuse persistent facial erythema of rosacea (scored 3 or 4 according to Clinician's Erythema Assessment [CEA]);
  • Subjects with moderate or severe papulopustular rosacea (scored 3 or 4 according to the Investigator's Global Assessment [IGA]);
  • Female subjects of childbearing potential with a negative urine pregnancy test (UPT);
  • Female subjects of childbearing potential must practice a highly effective method of contraception during the study;
  • Females subjects of non-childbearing potential;

Main Exclusion Criteria:

  • Subjects with particular forms of rosacea or other concomitant facial dermatoses that may be confounded with rosacea;
  • Subjects with more than 2 nodules of rosacea on the face;
  • 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;
  • 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;

Treatment and study plan

Brimonidine 0.33% gel (Br)

Drug

CD07805/47 (Br) placebo gel

Other

Ivermectin 1% cream (IVM)

Drug

CD5024 (IVM) placebo cream

Other

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

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

Acronym: MOSAIC

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 26, 2015
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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