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Investigating the effect of ((WartOver)) ointment in the treatment of skin warts

Evaluation of the efficacy and safety of ((WartOver)) topical ointment for the treatment of cutaneous warts: a randomized triple-blind clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200509047352N2
Enrollment
60
Registered
2023-01-27
Start date
2023-02-04
Completion date
Unknown
Last updated
2023-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous Warts. Viral warts

Interventions

Intervention 1: Intervention group: Wart Over ointment consists of 10% methanol extract of palm and Isopropyl cera alba (White wax), White petrolatum, Myristate, Propylene glycol palmitostearate and O

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Over 18 years of age The participant is able to understand the conditions and instructions of the clinical trial The presence of up to 5 skin warts with an area of up to 1 cm Presence of the lesion at least 4 weeks in the baseline visit At least 4 weeks have passed since other treatments such as cryotherapy and... Willing to sign an informed consent to participate in this study

Exclusion criteria

Exclusion criteria: Pregnancy and lactation history of skin malignancy and premalignancy (eg, actinic keratosis) immunodeficiency (eg, due to chemotherapy, glucocorticoids, systemic steroids, genetic immunodeficiency, transplant status, AIDS, etc.) lesions in the genital area eyelid involvement complicated infection receipt of any human papillomavirus (HPV) vaccine within 6 months of enrollment any current skin disease or systemic disease (eg, psoriasis, atopic dermatitis, eczema, sun damage) or condition that, in the opinion of the researcher, participating in the study may expose the participant to unnecessary risk or interfere with the conduct of the study or evaluations, such as sunburn, excessive hair, open wounds.

Design outcomes

Primary

MeasureTime frame
Number of patients with complete removal of target cutaneous wart dusing 12 weeks (or less) after treatment. Timepoint: Before initial of treatment and then every month after starting to use wart-over ointment (with palm extract) or placebo until the skin wart is completely removed, the lesion is photographed. The treatment lasts up to 12 weeks. Method of measurement: Reduction of the wart area or its complete removal will be evaluated by the digital lesion photos which are taken before the start of the treatment and then at each visit (monthly) and for a maximum period of 12 weeks, by Image-j software.

Secondary

MeasureTime frame
The percentage of skin wart area change during maximum 12 weeks. Timepoint: Before initial of treatment and then every month after starting to use wart-over ointment (with palm extract) or placebo until the skin wart is completely removed, the lesion is photographed. The treatment lasts up to 12 weeks. Method of measurement: Reduction of the wart area or its complete removal will be evaluated by the digital lesion photos which are taken before the start of the treatment and then at each visit (monthly) and for a maximum period of 12 weeks, by Image-j software.;Investigating of patients' satisfaction with the treatment. Timepoint: At the beginning of the study and before the start of the intervention and then the end of the treatment period if the wart is completely removed or the end of the 12th week if the area of the wart is reduced. Method of measurement: Give score with using a five-point scale (one = very dissatisfied, five = very satisfied).;Investigating the treatment period required for the complete clearance of cutaneous warts with "WartOver" topical ointment. Timepoint: The Assessment of treatment period required for the complete clearance of cutaneous warts with "WartOver" topical ointment would be conducted in the group receiving ((WartOver)) topical ointment after the completion of treatment (in the 12th week or in the last visit in which the researcher determines complete clearance). Method of measurement: In participants who will achieve partial or complete clearance of cutaneous warts with the use of ointment, the duration of treatment will be recorded and reported.;Investigating the recurrence of cutaneous warts in case of complete removal. Timepoint: One and three months after the complete removal of the cutaneous wart and discontinuing treatment. Method of measurement: Face-to-face visit and examination of the treated area.;Investigation of side effect. Timepoint: Side effect investigation during the use of the ointment for a maximum of 12 weeks.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAzin Ayatollahi

Tehran University of Medical Sciences

a-ayatollahi@sina.tums.ac.ir+98 21 8896 0880

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026