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IRCT20200509047352N2 IRCT 2023-01-27 Tehran University of Medical Sciences 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 2023-02-04 anticipated 60 Complete https://irct.ir/trial/65827 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization by Minimization will be used to allocate participants to one of the two treatment or vehicle arms. For this purpose, we will use MinimPy version 2.0 software. In this software, the minimization and reduction of the differences between the two arms are accomplished by specifying covariates that are likely to play a role in the prognosis of the disease and by using the marginal imbalance calculation by the software. covariates include age, gender, duration of cutaneous warts, number of warts in each patient, history of treatment, location, and type of warts, Blinding description: None of the participants, researchers, trial administrators, other health care personnel (doctors, nurses, etc.) who are responsible for the care of the patients, data collectors, and outcomes evaluators will be aware of the allocation of patients to the two groups under study. To apply blinding in this trial, the similarities between the interventions in the two study treatment groups are predicted. Therefore, the placebo will be produced in similar packages, with similar physical properties (in terms of color, smell, appearance, etc.). The amount of consumption and the number of times of consumption were the same in both products. The only difference between these two products would be the code A or B inserted on the respective package and box by the designated pharmacist. Others will be unaware of the nature of these two products and the codes mentioned in them. Due to the real-time allocation of participants in MinimPy software, as well as the presence of a random component in the allocation algorithm of this software, in addition to obtaining two arms that are as similar as possible, Allocation Concealment would also implement properly. In this way, in addition to blinding the participants and personnel of the clinical study (in order to prevent performance bias), it is possible to ensure the blinding of the result evaluation (in order to prevent detection bias) and to conduct the study in a triple-blind manner. At the end of the analyses of the results, codes will be broken and the nature of both groups would be determined. 2-3 Cutaneous Warts. 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 Oleyl alcohol, which is manufactured by Aram Aras Pishdad Azma pharmaceutical company for the treatment of skin warts. The ointment should be used at least 2 times a day on the target site until the wart is completely removed or for a maximum of 12 weeks. Intervention 2: Control group: placebo ointment does not contain palm methanolic extract, but other compounds such as Isopropyl cera alba (White wax), White petrolatum, Myristate, Propylene glycol palmitostearate, and Oleyl alcohol are presence in the formulation. Placebo is manufatured by Aram Aras Pishdad Azma pharmaceutical company for the clinical trial of skin warts and it is completely similar to the drug in terms of color and smell. The ointment should be used at least 2 times a day on the target site until the wart is completely removed or for a maximum of 12 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to confidentiality
public Azin Ayatollahi
The Center for Research and Training in Skin Diseases and Leprosy, No. 415, Naderi St., Taleghani Ave., Tehran, Iran
Tehran Iran (Islamic Republic of) 1416613675 +98 21 8896 0880 a-ayatollahi@sina.tums.ac.ir Tehran University of Medical Sciences scientific Azin Ayatollahi
The Center for Research and Training in Skin Diseases and Leprosy, No. 415, Naderi St., Taleghani Ave., Tehran, Iran
Tehran Iran (Islamic Republic of) 1416613675 +98 21 8896 0880 a-ayatollahi@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) 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 18 years 65 years Both 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. B07 Viral warts Treatment - Drugs Placebo 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 Oleyl alcohol, which is manufactured by Aram Aras Pishdad Azma pharmaceutical company for the treatment of skin warts. The ointment should be used at least 2 times a day on the target site until the wart is completely removed or for a maximum of 12 weeks. Control group: placebo ointment does not contain palm methanolic extract, but other compounds such as Isopropyl cera alba (White wax), White petrolatum, Myristate, Propylene glycol palmitostearate, and Oleyl alcohol are presence in the formulation. Placebo is manufatured by Aram Aras Pishdad Azma pharmaceutical company for the clinical trial of skin warts and it is completely similar to the drug in terms of color and smell. The ointment should be used at least 2 times a day on the target site until the wart is completely removed or for a maximum of 12 weeks. 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. 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. Method of measurement: In case of occurrence, side effects are recorded in the case report form in each visit (monthly) and also patients can report adverse effects anytime according to the contact number provided to them. Aram pishdad aras azma Ltd. Approved 2022-08-30 Research Ethics Committees of School of Medicine- Tehran University of Medical Sciences Office of Research Vice-Chancellor, Faculty of Medicine Building No. 1, Tehran University of Medical Sciences, Porsina St.,Qods St., Enqelab St., Tehran Tehran Tehran Iran (Islamic Republic of)