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Completed

NCT Number: NCT07012811

Treatment of Plane Warts With Topical and Oral Retinoids

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.

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Key information

Conditions

Plane Warts

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tishreen University- Faculty of Medicine

Latakia, Latakia Governorate, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Topical tretinoin 0.05%

Drug

Topical tretinoin cream 0.05% applied once daily at night

Topical tretinoin 0.05% + oral isotretinoin (0.5 mg/kg/day)

Drug

Topical tretinoin cream 0.05% once daily at night + oral isotretinoin capsule in the dose of 0.5 mg/kg/day

Primary outcomes

  1. Response Rate, as Measured by the Reduction in Number of Lesions at Week 4

    Time frame: 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).

  2. Response Rate, as Measured by the Reduction in Number of Lesions at Week 8

    Time frame: 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).

  3. Response Rate, as Measured by the Reduction in Number of Lesions at Week 12

    Time frame: 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 outcomes

  1. Safety, as Measured by the Number of Patients With at Least one Adverse Effect

    Time frame: week 12

    The adverse effects are defined as unwanted effects related directly to the drug

  2. Recurrence Rate, as Measured by the Number of Patients who Have Recurrent Lesions After 12 Weeks of Termination of Therapy

    Time frame: 12 weeks after termination of therapy

    The recurrence is defined as reappearance of lesions at the same locations after complete response

Sponsors and collaborators

Lead sponsor

Latakia University

Other

Registry information

Official study title

Evaluation of Topical Tretinoin 0.05% Alone Versus Combination With Oral Isotretinoin (0.5 mg/kg/Day) in the Treatment of Plane Warts

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 10, 2025
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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