Topical 0.5% Ivermectin Cream for Treatment of Demodicidosis

Rosacea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02036229
• Other study ID #: topical ivermectin, demodex
• Status: Recruiting
• Phase: Phase 3
• First received: January 2, 2014
• Last updated: January 10, 2015
• Start date: February 2014
• Est. completion date: June 2016

Study information

• Verified date: January 2015
• Source: Rabin Medical Center
• Contact: Rina Segal, MD
• Phone: 972505206134
• Email: rinas3[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Demodicidosis
• Rosacea

Intervention

Drug:
• ivermectin cream 0.5%
Each participant will be treated with topical ivermectin cream 0.5% qd for one half of the face and 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.

Locations

Country	Name	City	State
Israel	RabinMC, Dermatology dept.	Petah-Tiqva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A decrease in mite density in skin surface biopsy after treatment with topical ivermectin (=5 mites/cm2 for skin lesions).		5 months	No
Secondary	Clinical improvement	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.	5 months	No
Secondary	A comparable dermoscopic improvement in the demodicidosis features	dermoscopic demodicidosis features: number of demodex tails; demodex follicular openings; reticular dilated vessels.	5 months	No