Topical 0.5% Ivermectin Cream for Treatment of Demodicidosis

NCT ID: NCT02036229

Last Updated: 2015-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2016-06-30

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)

Conditions

Demodicidosis; Rosacea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

ivermectin cream 0.5%

Intervention Type: DRUG

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.

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.

Group Type: PLACEBO_COMPARATOR

ivermectin cream 0.5%

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Rina Segal

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rina Segal, MD

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center

Locations

RabinMC, Dermatology dept.

Petah Tikva, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Rina Segal, MD

Role: CONTACT

rinas3@clalit.org.il

972505206134

Facility Contacts

Rina Segal, MD

Role: primary

972505206134

Other Identifiers

topical ivermectin, demodex

Identifier Type: -

Identifier Source: org_study_id