Topical 0.5% Ivermectin Cream for Treatment of Demodicidosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2015 by Rabin Medical Center.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Rina Segal, Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT02036229
First received: January 2, 2014
Last updated: January 10, 2015
Last verified: January 2015
  Purpose
The purpose of this study is to determine whether 0.5% ivermectin cream is effective in the treatment of demodicidosis (including papulopustular rosacea)

Condition Intervention Phase
Demodicidosis
Rosacea
Drug: ivermectin cream 0.5%
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: a Randomised, Double Blind, Placebo Controlled, Half- Face Study to Evaluate the Effect of Topical Ivermectin Cream 0.5% on Demodicidosis

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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.


Estimated Enrollment: 50
Study Start Date: February 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02036229

Locations
Israel
RabinMC, Dermatology dept.
Petah-Tiqva, Israel
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Rina Segal, MD Rabin Medical Center
  More Information

Responsible Party: Rina Segal, MD, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02036229     History of Changes
Other Study ID Numbers: topical ivermectin, demodex 
Study First Received: January 2, 2014
Last Updated: January 10, 2015

Keywords provided by Rabin Medical Center:
demodex
demodicidosis
rosacea
ivermectin

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Ivermectin
Antiparasitic Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on January 19, 2017