Back to resultsTopical 0.5% Ivermectin Cream for Treatment of Demodicidosis
Primary Purpose
Demodicidosis, Rosacea
Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
ivermectin cream 0.5%
Sponsored by
About this trial
This is an interventional treatment trial for Demodicidosis focused on measuring demodex, demodicidosis, rosacea, ivermectin
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
Sites / Locations
- RabinMC, Dermatology dept.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
0.5% ivermectin cream
vehicle cream
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
A decrease in mite density in skin surface biopsy after treatment with topical ivermectin (≤5 mites/cm2 for skin lesions).
Secondary Outcome Measures
Clinical improvement
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
dermoscopic demodicidosis features:
number of demodex tails
demodex follicular openings
reticular dilated vessels.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02036229
Brief Title
Topical 0.5% Ivermectin Cream for Treatment of Demodicidosis
Official Title
a Randomised, Double Blind, Placebo Controlled, Half- Face Study to Evaluate the Effect of Topical Ivermectin Cream 0.5% on Demodicidosis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
June 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Demodicidosis, Rosacea
Keywords
demodex, demodicidosis, rosacea, ivermectin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
0.5% ivermectin cream
Arm Type
Experimental
Arm Description
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.
Arm Title
vehicle cream
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
ivermectin cream 0.5%
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Clinical improvement
Description
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.
Time Frame
5 months
Title
A comparable dermoscopic improvement in the demodicidosis features
Description
dermoscopic demodicidosis features:
number of demodex tails
demodex follicular openings
reticular dilated vessels.
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rina Segal, MD
Phone
972505206134
Email
rinas3@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rina Segal, MD
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
RabinMC, Dermatology dept.
City
Petah-Tiqva
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rina Segal, MD
Phone
972505206134
First Name & Middle Initial & Last Name & Degree
Rina Segal, MD
12. IPD Sharing Statement
Learn more about this trial
Topical 0.5% Ivermectin Cream for Treatment of Demodicidosis
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