Topical 0.5% Ivermectin Cream for Treatment of Demodicidosis

Condition(s) targeted: Demodicidosis; Rosacea

Intervention: ivermectin cream 0.5% (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Rabin Medical Center

Official(s) and/or principal investigator(s):
Rina Segal, MD, Principal Investigator, Affiliation: Rabin Medical Center

Overall contact:
Rina Segal, MD, Phone: 972505206134, Email: rinas3@clalit.org.il

The purpose of this study is to determine whether 0. 5% ivermectin cream is effective in the treatment of demodicidosis (including papulopustular rosacea)

Official title: a Randomised, Double Blind, Placebo Controlled, Half- Face Study to Evaluate the Effect of Topical Ivermectin Cream 0.5% on Demodicidosis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: A decrease in mite density in skin surface biopsy after treatment with topical ivermectin (≤5 mites/cm2 for skin lesions).

Secondary outcome:

Clinical improvement

A comparable dermoscopic improvement in the demodicidosis features

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- subjects with clinical and laboratory diagnosis of demodicidosis with symmetrical

facial eruption who are willing to comply with study requirements Exclusion Criteria:

- known hypersensitivity to ivermectin.

- pregnancy

- immunodeficiency such as HIV or immunosuppressive therapy

- concomitant use of systemic antibiotics or steroids

Rina Segal, MD, Phone: 972505206134, Email: rinas3@clalit.org.il

RabinMC, Dermatology dept., Petah-Tiqva, Israel; Recruiting
Rina Segal, MD, Phone: 972505206134
Rina Segal, MD, Principal Investigator

Starting date: February 2014
Last updated: January 10, 2015