Phase 4 N=190 Randomized Quadruple-blind Treatment

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

Rosacea

Bottom Line

View on ClinicalTrials.gov: NCT02616250 ↗

Enrolled (actual)

190

Serious AEs

3.2%

Results posted

Oct 2017

Primary outcome: Primary: Efficacy Variable: Percentage of Patients Defined as Success on the Global Rosacea Severity Grading Scale Called Investigator's Global Assessment (IGA): — 53; 35 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Brimonidine 0.33% gel (Br) (Drug); CD07805/47 (Br) placebo gel (Other); Ivermectin 1% cream (IVM) (Drug); CD5024 (IVM) placebo cream (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Galderma R&D
Primary completion: Sep 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Efficacy Variable: Percentage of Patients Defined as Success on the Global Rosacea Severity Grading Scale Called Investigator's Global Assessment (IGA):	53; 35	—

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.

Eligibility Criteria

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;

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02616250). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.