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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

Tracking Information
First Submitted Date  ICMJE November 24, 2015
First Posted Date  ICMJE November 26, 2015
Results First Submitted Date  ICMJE September 19, 2017
Results First Posted Date  ICMJE October 19, 2017
Last Update Posted Date March 12, 2018
Study Start Date  ICMJE December 2015
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2017)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: November 25, 2015)
Efficacy variable: Percentage of patients across the 5 scores of the global rosacea severity grading scale called Investigator's Global Assessment (IGA). [ Time Frame: week 12 ]
Percentage of patients across scores of IGA.
Change History Complete list of historical versions of study NCT02616250 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MirvasO Soolantra Association In the Treatment of Moderate to Severe rosaCea.
Official Title  ICMJE Efficacy and Safety of Ivermectin 1% Topical Cream Associated With Brimonidine 0.33% Topical Gel in the Treatment of Moderate to Severe Rosacea
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rosacea
Intervention  ICMJE
  • Drug: Brimonidine 0.33% gel (Br)
  • Other: CD07805/47 (Br) placebo gel
  • Drug: Ivermectin 1% cream (IVM)
  • Other: CD5024 (IVM) placebo cream
Study Arms  ICMJE
  • 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.

    Interventions:
    • 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.
    Interventions:
    • Other: CD07805/47 (Br) placebo gel
    • Other: CD5024 (IVM) placebo cream
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 13, 2018)
190
Original Estimated Enrollment  ICMJE
 (submitted: November 25, 2015)
188
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02616250
Other Study ID Numbers  ICMJE RD.03.SPR.105069
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Galderma
Study Sponsor  ICMJE Galderma
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Galderma
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP