a Randomised, Double Blind, Placebo Controlled, Half- Face Study to Evaluate the Effect of Topical Ivermectin Cream 0.5% on Demodicidosis
Overview
- Phase
- Phase 3
- Intervention
- ivermectin cream 0.5%
- Conditions
- Demodicidosis
- Sponsor
- Rabin Medical Center
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- A decrease in mite density in skin surface biopsy after treatment with topical ivermectin (≤5 mites/cm2 for skin lesions).
- Last Updated
- 11 years ago
Overview
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)
Investigators
Rina Segal
MD
Rabin Medical Center
Eligibility 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
Arms & Interventions
0.5% ivermectin cream
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.
Intervention: ivermectin cream 0.5%
vehicle cream
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.
Intervention: ivermectin cream 0.5%
Outcomes
Primary Outcomes
A decrease in mite density in skin surface biopsy after treatment with topical ivermectin (≤5 mites/cm2 for skin lesions).
Time Frame: 5 months
Secondary Outcomes
- A comparable dermoscopic improvement in the demodicidosis features(5 months)
- Clinical improvement(5 months)