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

Rosacea Clinical Trial

— MOSAIC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02616250
• Other study ID #: RD.03.SPR.105069
• Status: Completed
• Phase: Phase 4
• Start date: December 2015
• Est. completion date: September 2016

Study information

• Verified date: February 2018
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Rosacea

Intervention

Drug:
• Brimonidine 0.33% gel (Br)

Other:
• CD07805/47 (Br) placebo gel

Drug:
• Ivermectin 1% cream (IVM)

Other:
• CD5024 (IVM) placebo cream

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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