Treatment of Plane Warts With Topical and Oral Retinoids

NCT07012811 | Completed Phase 4

• 1 other identifier: TishreenU - Plane Warts
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Plane Warts

Keywords

Human papillomavirus; Tretinoin; Isotretinoin

Outcome Measures

Primary Outcomes (3)

• Response Rate, as Measured by the Reduction in Number of Lesions at 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).

  Week 4

• Response Rate, as Measured by the Reduction in Number of Lesions at 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).

  Week 8

• Response Rate, as Measured by the Reduction in Number of Lesions at 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).

  Week 12

Secondary Outcomes (2)

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

  week 12

• 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

Study Arms (2)

Group A

ACTIVE COMPARATOR

Patients apply tretinoin cream 0.05% once daily at night for 3 months

Drug: Topical tretinoin 0.05%

Group B

EXPERIMENTAL

Patients apply tretinoin cream 0.05% and receive oral isotretinoin capsule in the dose of 0.5 mg/kg/day for 3 months

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

Interventions

Topical tretinoin 0.05% DRUG

Topical tretinoin cream 0.05% applied once daily at night

Group A

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

Group B

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tishreen University: lead

Study Sites (1)

Tishreen University- Faculty of Medicine

Latakia, Latakia Governorate, Syria

Location

Related Publications (6)

• Singh R, Pandey SS: Efficacy of topical 5% 5-fluorouracil and 0.05% tretinoin and electrosurgery in the treatment of plane warts: a randomized controlled comparative trial. Nepal J Dermatol Venereol & Leprol. 2021, 19(1):55-9

  BACKGROUND

• Randhawa NK, Kumar S, Agarwal US, Agarwal P, Bansal A, Meena S: To evaluate efficacy and safety of low dose oral isotretinoin (20 mg/day) alone versus combination of low dose oral isotretinoin (20 mg/day) plus topical tretinoin (0.1%) in gel formulation in the treatment of verruca plana. J Clin Exp Dermatol Res. 2023, 14:635.

  BACKGROUND

• Nooruldeen AD, Saeed MY: Efficacy and safety of oral isotretinoin in treatment of plane warts. Bali Med J. 2021, 10(3): 1076-7080

  BACKGROUND

• Dong ZY, He MJ, Hu Y, Wang F, Ran DL, Fu DS, He Q, Yang RP, Zhang JA. Unveiling the Mechanism of Retinoic Acid Therapy for Cutaneous Warts: Insights from Multi-Omics Integration. Clin Cosmet Investig Dermatol. 2024 Dec 18;17:2923-2932. doi: 10.2147/CCID.S504391. eCollection 2024.

  PMID: 39712939 BACKGROUND

• Kaur GJ, Brar BK, Kumar S, Brar SK, Singh B. Evaluation of the efficacy and safety of oral isotretinoin versus topical isotretinoin in the treatment of plane warts: a randomized open trial. Int J Dermatol. 2017 Dec;56(12):1352-1358. doi: 10.1111/ijd.13727. Epub 2017 Sep 13.

  PMID: 28901534 BACKGROUND

• Sterling JC, Gibbs S, Haque Hussain SS, Mohd Mustapa MF, Handfield-Jones SE. British Association of Dermatologists' guidelines for the management of cutaneous warts 2014. Br J Dermatol. 2014 Oct;171(4):696-712. doi: 10.1111/bjd.13310. Epub 2014 Oct 1. No abstract available.

  PMID: 25273231 BACKGROUND

MeSH Terms

Interventions

Tretinoin; Isotretinoin

Intervention Hierarchy (Ancestors)

Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Officials

• Zeina M Habib, MD

  Tishreen University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 10, 2025
• Study Start: February 12, 2024
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Beginning 2 months and ending 5 months following publication
• Access Criteria: researchers who provide a methodological proposal

Locations

SY (1)