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IRCT20251112067973N1 IRCT 2026-06-29 Tehran University of Medical Sciences Efficacy and safety of vaginal probiotic suppository plus cryotherapy in comparison with cryotherapy monotherapy in improving genital warts Efficacy and safety of vaginal probiotic suppository plus cryotherapy in comparison with cryotherapy monotherapy in improving genital warts 2026-08-02 anticipated 20 Recruiting https://irct.ir/trial/87426 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be performed using a block randomization method with a block size of 4 and a 1:1 allocation ratio. The allocation sequence will be generated by an independent statistician, separate from the treatment team, using Excel software. Participants will be assigned to groups via sequentially numbered, sealed envelopes (SNOSE), which will be opened only after definitive enrollment of each patient by the responsible investigator. This ensures that allocation concealment is maintained and that the assignment process is independent of enrollment. 1-2 Genital wart. Intervention 1: Intervention group:Patients in this group will receive 4 sessions of cryotherapy every three weeks. Each session will be performed by a board-certified dermatologist using a liquid nitrogen spray device (Model C-609, Azin Co., Iran). Liquid nitrogen at −196°C will be applied as a direct spray for 2 seconds per lesion per session. In addition, patients will receive 3 consecutive 10-day courses (one per month) of Provage vaginal probiotic suppositories (Gostaresh Milad Pharmed Co., Iran). Each 500 mg capsule contains Lactobacillus rhamnosus and Lactobacillus gasseri (>500 million CFU per strain). The suppository is self-administered vaginally each night before sleep using an applicator; patients remain supine for 10 minutes after insertion to facilitate absorption. Use is suspended during menstrual bleeding. Intervention 2: Patients in this group will receive 4 sessions of cryotherapy every three weeks, performed by the same board-certified dermatologist using the same device and protocol as described above. No additional pharmacological intervention will be administered. Yes - There is a plan to make this available What will be shared: IPD collected for the primary outcome measure are to be shared When: Starting after publication To whom: Data is available upon request Conditions: Requests are reviewed on a case-by-case (individual) basis. Where to obtain: Via email address: Yektaghanemd@gmail.com How to obtain: Submit your request online via email. They must reply within 10 working days (usually 3–20 days in practice). Receive the file digitally or (rarely) in physical form. Most simple requests take 1–3 weeks. Comments:
public Yekta Ghane
Autoimmune Bullous Diseases Research Center, Razi Hospital, Razi Alley, Vahdat-e Eslami St., below Vahdat-e Eslami Sq., Tehran, Iran
Tehran Iran (Islamic Republic of) 1199663911 +98 21 5557 5141 Yektaghanemd@gmail.com Tehran University of Medical Sciences scientific Yekta Ghane
Autoimmune Bullous Diseases Research Center, Razi Hospital, Razi Alley, Vahdat-e Eslami St., below Vahdat-e Eslami Sq., Tehran, Iran
Tehran Iran (Islamic Republic of) 1199663911 +98 21 5557 5141 Yektaghanemd@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) 20 women with genital warts 18 years 50 years Female History of immunodeficiency Pregnancy and/or Breastfeeding High-grade HPV Precancerous and Cancerous Lesions No history of intercourse A63.0 Anogenital (venereal) warts Treatment - Other Treatment - Other Intervention group:Patients in this group will receive 4 sessions of cryotherapy every three weeks. Each session will be performed by a board-certified dermatologist using a liquid nitrogen spray device (Model C-609, Azin Co., Iran). Liquid nitrogen at −196°C will be applied as a direct spray for 2 seconds per lesion per session. In addition, patients will receive 3 consecutive 10-day courses (one per month) of Provage vaginal probiotic suppositories (Gostaresh Milad Pharmed Co., Iran). Each 500 mg capsule contains Lactobacillus rhamnosus and Lactobacillus gasseri (>500 million CFU per strain). The suppository is self-administered vaginally each night before sleep using an applicator; patients remain supine for 10 minutes after insertion to facilitate absorption. Use is suspended during menstrual bleeding. Patients in this group will receive 4 sessions of cryotherapy every three weeks, performed by the same board-certified dermatologist using the same device and protocol as described above. No additional pharmacological intervention will be administered. Total number and the size of the lesions. Timepoint: Every 3 weeks. Method of measurement: Counting the lesions and ruler. Tehran University of Medical Sciences Approved 2025-05-11 Ethics committee of Immunology, Asthma and Allergy Research Institute Tehran University of Medical Sciences, Poursina St, Qods St, Enqelab St, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)