Efficacy of Ivermectin in the Treatment of Plane Warts
A Prospective Randomized Controlled Clinical Trial to Evaluate the Efficacy of Oral and Topical Ivermectin in the Treatment of Plane Warts
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Asyut, Egypt
- Department of Dermatology , Al-Azhar university hospital
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria: • Clinical and dermoscopic diagnosis of the plane warts.
- No prior treatment for warts in the last 4 weeks.
- Patients of both sex (male - female)
- Age more than 5 years or weight more than 15 kg.
Exclusion Criteria:
• Patients with other types of warts (e.g., common, plantar, genital).
- History of hypersensitivity or allergy to ivermectin or its components.
- Patients who have received systemic immunosuppressive therapy within the last 3 months.
- Presence of chronic skin conditions that may interfere with evaluation (e.g., eczema, psoriasis).
- Patients with immunodeficiency disorders (e.g., HIV, organ transplant recipients).
- Pregnant or lactating females.
- Patients currently on systemic antiviral or immunomodulatory treatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Group1 : topical ivermectin
Patients will receive topical ivermectin cream applied twice daily to plane warts for 3 months
|
An antiparasitic medication evaluated for its immunomodulatory and antiviral efficacy in clearing plane warts.
it will be administered to patients according to their assigned group protocol.
|
|
Experimental: Group 2 : oral ivermectin
Patients will receive oral ivermectin once weekly for 3 months
|
An antiparasitic medication evaluated for its immunomodulatory and antiviral efficacy in clearing plane warts.
it will be administered to patients according to their assigned group protocol.
|
|
Placebo Comparator: control group 1
|
Patients in the control group will receive placebo,they will undergo standard clinical observation and follow up to monitor the natural course of the plane warts.
|
|
Placebo Comparator: control group 2
|
Patients in the control group will receive placebo,they will undergo standard clinical observation and follow up to monitor the natural course of the plane warts.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
percentage of patients achieving complete clearance of plane warts
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- AZHAR-DERM-2025-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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