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Trial record 6 of 106 for:    IVERMECTIN

Topical 0.5% Ivermectin Cream for Treatment of Demodicidosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02036229
Recruitment Status : Unknown
Verified January 2015 by Rina Segal, Rabin Medical Center.
Recruitment status was:  Recruiting
First Posted : January 14, 2014
Last Update Posted : January 13, 2015
Sponsor:
Information provided by (Responsible Party):
Rina Segal, Rabin Medical Center

Tracking Information
First Submitted Date  ICMJE January 2, 2014
First Posted Date  ICMJE January 14, 2014
Last Update Posted Date January 13, 2015
Study Start Date  ICMJE February 2014
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2014)
A decrease in mite density in skin surface biopsy after treatment with topical ivermectin (≤5 mites/cm2 for skin lesions). [ Time Frame: 5 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02036229 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2014)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Topical 0.5% Ivermectin Cream for Treatment of Demodicidosis
Official Title  ICMJE a Randomised, Double Blind, Placebo Controlled, Half- Face Study to Evaluate the Effect of Topical Ivermectin Cream 0.5% on Demodicidosis
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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Demodicidosis
  • Rosacea
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: ivermectin cream 0.5%
  • 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.
    Intervention: Drug: ivermectin cream 0.5%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 12, 2014)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2016
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02036229
Other Study ID Numbers  ICMJE topical ivermectin, demodex
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rina Segal, Rabin Medical Center
Study Sponsor  ICMJE Rabin Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rina Segal, MD Rabin Medical Center
PRS Account Rabin Medical Center
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP