Treatment of Plane Warts With Topical and Oral Retinoids

Phase 4

Completed

• Conditions: Plane Warts
• Interventions: Drug: Topical tretinoin 0.05%; Drug: Topical tretinoin 0.05% + oral isotretinoin (0.5 mg/kg/day)

• Registration Number: NCT07012811
• Lead Sponsor: Tishreen University

Brief Summary

The aim of this study was to compare the effectiveness and safety of topical tretinoin cream 0.05% alone against combination with oral isotretinoin (0.5 mg/kg/day) for treatment of plane warts.

Detailed Description

This study included 39 patients divided into two groups. Treatment was given for three months duration. Patients were followed-up for further three months to assess the recurrence rate. Combination treatment led to a faster resolution and a higher percentage of complete response. It presents a promising effective alternative option for treatment of plane warts.

Study Timeline

• Study Start: 2024-02-12
• Primary Completion: 2025-03-30
• Study Completion: 2025-03-30
• Study First Submitted: 2025-05-29
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-08
• Last Update Submitted: 2025-06-08
• Study First Posted: 2025-06-10
• Last Update Posted: 2025-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Patients above 12 years diagnosed with plane warts.
• Patients who had not received any treatment for warts in the last month.

Exclusion Criteria

• Pregnancy and lactation.
• Abnormal lipid profile.
• Significant hepatic or renal dysfunction.
• Depression.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Topical tretinoin 0.05%	Patients apply tretinoin cream 0.05% once daily at night for 3 months
Group B	Topical tretinoin 0.05% + oral isotretinoin (0.5 mg/kg/day)	Patients apply tretinoin cream 0.05% and receive oral isotretinoin capsule in the dose of 0.5 mg/kg/day for 3 months

Primary Outcome Measures

Name	Time	Method
Response Rate, as Measured by the Reduction in Number of Lesions at Week 4	Week 4	The response is assessed according to the decrease in number of lesions as followed: complete response (total clearance of warts), partial response (decease in the number of lesion ≥ 50%), no response (decrease in the number of lesion \<50% or no clearance).
Response Rate, as Measured by the Reduction in Number of Lesions at Week 8	Week 8	The response is assessed according to the decrease in number of lesions as followed: complete response (total clearance of warts), partial response (decease in the number of lesion ≥ 50%), no response (decrease in the number of lesion \<50% or no clearance).
Response Rate, as Measured by the Reduction in Number of Lesions at Week 12	Week 12	The response is assessed according to the decrease in number of lesions as followed: complete response (total clearance of warts), partial response (decease in the number of lesion ≥ 50%), no response (decrease in the number of lesion \<50% or no clearance).

Secondary Outcome Measures

Name	Time	Method
Safety, as Measured by the Number of Patients With at Least one Adverse Effect	week 12	The adverse effects are defined as unwanted effects related directly to the drug
Recurrence Rate, as Measured by the Number of Patients who Have Recurrent Lesions After 12 Weeks of Termination of Therapy	12 weeks after termination of therapy	The recurrence is defined as reappearance of lesions at the same locations after complete response

Trial Locations

Locations (1)

Tishreen University- Faculty of Medicine; 🇸🇾 Latakia, Syrian Arab Republic