Topical 0.5% Ivermectin Cream for Treatment of Demodicidosis

Phase 3

• Conditions: Rosacea; Demodicidosis
• Interventions: Drug: ivermectin cream 0.5%

• Registration Number: NCT02036229
• Lead Sponsor: Rabin Medical Center

Brief Summary

The purpose of this study is to determine whether 0.5% ivermectin cream is effective in the treatment of demodicidosis (including papulopustular rosacea)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-02
• Study First Submitted QC: 2014-01-12
• Study First Posted: 2014-01-14
• Study Start: 2014-02
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-10
• Last Update Posted: 2015-01-13
• Primary Completion: 2015-12
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.5% ivermectin cream	ivermectin cream 0.5%	Each participant will be treated with topical ivermectin cream 0.5% qd for one half of the face for 1 month. In the second month all patients will be treated with ivermectin cream for the entire skin involvement.
vehicle cream	ivermectin cream 0.5%	Each participant will be treated with a vehicle cream qd for the other half of the face for 1 month. In the second month all patients will be treated with ivermectin cream for the entire skin involvement.

Primary Outcome Measures

Name	Time	Method
A decrease in mite density in skin surface biopsy after treatment with topical ivermectin (≤5 mites/cm2 for skin lesions).	5 months

Secondary Outcome Measures

Name	Time	Method
A comparable dermoscopic improvement in the demodicidosis features	5 months	dermoscopic demodicidosis features: * number of demodex tails; * demodex follicular openings; * reticular dilated vessels.
Clinical improvement	5 months	Clinical improvement will be assessed by objective evaluation of erythema, dryness, scaling, roughness, and/or papules/pustules in skin lesions and subjective evaluation of itch and dryness.

Trial Locations

Locations (1)

RabinMC, Dermatology dept.; 🇮🇱 Petah-Tiqva, Israel