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CompletedNCT07012811Updated Jun 10, 2025

Treatment of Plane Warts With Topical and Oral Retinoids

A Phase 4 interventional study of Topical tretinoin 0.05% and Topical tretinoin 0.05% + oral isotretinoin (0.5 mg/kg/day) in Plane Warts, sponsored by Tishreen University. Completed at 1 site in Syrian Arab Republic. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2025-06-10.

Sponsored by Tishreen University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
39
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Plane Warts

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Keywords

  • Human papillomavirus
  • Tretinoin
  • Isotretinoin
03

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Pregnancy and lactation.
  • Abnormal lipid profile.
  • Significant hepatic or renal dysfunction.
  • Depression.
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
39 participants (actual)

Study arms

  • Active comparator
    Group A

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

    Drug: Topical tretinoin 0.05%

  • Experimental
    Group B

    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

  • DrugTopical tretinoin 0.05%

    Topical tretinoin cream 0.05% applied once daily at night

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

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

05

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Week 4

  2. 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).

    Time frame: Week 8

  3. 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).

    Time frame: Week 12

Secondary outcomes

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

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

    Time frame: week 12

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

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

    Time frame: 12 weeks after termination of therapy

06

Study locations

1 site
  • Tishreen University- Faculty of Medicine
    Latakia, Syrian Arab Republic
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References and documents

Publications

  • 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
  • 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.
  • Nooruldeen AD, Saeed MY: Efficacy and safety of oral isotretinoin in treatment of plane warts. Bali Med J. 2021, 10(3): 1076-7080
  • 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. PubMed 39712939 ↗
  • 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. PubMed 28901534 ↗
  • 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. PubMed 25273231 ↗

Individual participant data

Plan to share: Yes — Individual participant data that underlie the results of this study after deidentification

Supporting information: Study protocol, Sap, Csr

08

Registry details

Key details

Study ID
NCT07012811
Lead sponsor
Tishreen University
Responsible party
Sponsor
First posted
Jun 10, 2025
Start date
Feb 12, 2024
Primary completion
Mar 30, 2025
Completion
Mar 30, 2025
Last update
Jun 10, 2025

Study contacts

Zeina M Habib, MD
principal investigator · Tishreen University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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