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Trial record 1 of 1 for:
"Demodicidosis"
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 Rina Segal, Rabin Medical Center.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Rabin Medical Center
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
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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 (Participant, Care Provider, 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 Rina Segal, 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
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. | 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
| 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 Rina Segal, 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 July 13, 2017