Topical 0.5% Ivermectin Cream for Treatment of Demodicidosis

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

Conditions
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Demodicidosis, Rosacea

Intervention / Treatment
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* Drug: ivermectin cream 0.5%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.5% ivermectin cream<br>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. | Drug: ivermectin cream 0.5%<br>* 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.<br>|
| Placebo Comparator: vehicle cream<br>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. | Drug: ivermectin cream 0.5%<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| A comparable dermoscopic improvement in the demodicidosis features | dermoscopic demodicidosis features: number of demodex tails demodex follicular openings reticular dilated vessels. | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rosacea, demodex, demodicidosis, ivermectin