Topical 0.5% Ivermectin Cream for Treatment of Demodicidosis

January 10, 2015 updated by: Rina Segal, Rabin Medical Center

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petah-Tiqva, Israel
        • Recruiting
        • RabinMC, Dermatology dept.
        • Contact:
          • Rina Segal, MD
          • Phone Number: 972505206134
        • Principal Investigator:
          • Rina Segal, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Placebo Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
A decrease in mite density in skin surface biopsy after treatment with topical ivermectin (≤5 mites/cm2 for skin lesions).
Time Frame: 5 months
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical improvement
Time Frame: 5 months
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
Time Frame: 5 months

dermoscopic demodicidosis features:

  • number of demodex tails
  • demodex follicular openings
  • reticular dilated vessels.
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Investigators

  • Principal Investigator: Rina Segal, MD, Rabin Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

January 2, 2014

First Submitted That Met QC Criteria

January 12, 2014

First Posted (Estimate)

January 14, 2014

Study Record Updates

Last Update Posted (Estimate)

January 13, 2015

Last Update Submitted That Met QC Criteria

January 10, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • topical ivermectin, demodex

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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