Clinical trial NCT07012811: Treatment of Plane Warts With Topical and Oral Retinoids
Official title: Evaluation of Topical Tretinoin 0.05% Alone Versus Combination With Oral Isotretinoin (0.5 mg/kg/Day) in the Treatment of Plane Warts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Plane Warts
Keywords: Human papillomavirus
Tretinoin
Isotretinoin
Lead sponsor: Tishreen University
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 39
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Response Rate, as Measured by the Reduction in Number of Lesions at Week 4
timeFrame: Week 4
measure: Response Rate, as Measured by the Reduction in Number of Lesions at Week 8
timeFrame: Week 8
measure: Response Rate, as Measured by the Reduction in Number of Lesions at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Safety, as Measured by the Number of Patients With at Least one Adverse Effect
timeFrame: week 12
measure: Recurrence Rate, as Measured by the Number of Patients who Have Recurrent Lesions After 12 Weeks of Termination of Therapy
timeFrame: 12 weeks after termination of therapy
Other outcomes:
Locations:
city: Latakia
country: Syrian Arab Republic
facility: Tishreen University- Faculty of Medicine
Study officials:
affiliation: Tishreen University Hospital
name: Zeina M Habib, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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.
citation: Nooruldeen AD, Saeed MY: Efficacy and safety of oral isotretinoin in treatment of plane warts. Bali Med J. 2021, 10(3): 1076-7080
citation: 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.
citation: 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.
citation: 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.