Topical 0.5% Ivermectin Cream for Treatment of Demodicidosis

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Rabin Medical Center
Sponsor:
Information provided by (Responsible Party):
Rina Segal, Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT02036229
First received: January 2, 2014
Last updated: January 12, 2014
Last verified: January 2014
  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
Demodex
Demodicidosis
Topical Ivermectin
Drug: ivermectin cream 0.5%
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical improvement [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    dermoscopic demodicidosis features:

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


Estimated Enrollment: 50
Study Start Date: February 2014
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
Genders Eligible for Study:   Both
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

Contacts
Contact: Rina Segal, MD 972505206134 rinas3@clalit.org.il

Locations
Israel
RabinMC, Dermatology dept. Not yet recruiting
Petah-Tiqva, Israel
Contact: Rina Segal, MD    972505206134      
Principal Investigator: Rina Segal, MD         
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Rina Segal, MD Rabin Medical Center
  More Information

No publications provided

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 12, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:
demodex
demodicidosis
rosacea
ivermectin

Additional relevant MeSH terms:
Ivermectin
Anti-Infective Agents
Antiparasitic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014