Topical 0.5% Ivermectin Cream for Treatment of Demodicidosis

Clalit Health Services

Status and phase: Unknown; Phase 3

Conditions: Demodicidosis; Rosacea

Treatments: Drug: ivermectin cream 0.5%

Study type: Interventional

Funder types: Other

Identifiers

NCT02036229

topical ivermectin, demodex

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

0.5% ivermectin cream

Experimental group

Description:

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.

Treatment:

Drug: ivermectin cream 0.5%

vehicle cream

Placebo Comparator group

Description:

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.

Treatment:

Drug: ivermectin cream 0.5%