Overview

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

Status:
Completed

Trial end date:
2016-09-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Galderma
Galderma R&D

Treatments:

Brimonidine Tartrate
Ivermectin

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;