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

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ClinicalTrials.gov Identifier: NCT02616250
Recruitment Status : Completed
First Posted : November 26, 2015
Results First Posted : October 19, 2017
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
Galderma

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea

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



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)



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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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02616250


Locations
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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

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Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT02616250     History of Changes
Other Study ID Numbers: RD.03.SPR.105069
First Posted: November 26, 2015    Key Record Dates
Results First Posted: October 19, 2017
Last Update Posted: March 12, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Brimonidine Tartrate
Rosacea
Skin Diseases
Ivermectin
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
Antiparasitic Agents
Anti-Infective Agents