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IRCT20241115063720N2 IRCT 2026-09-29 Tehran University of Medical Sciences Evaluating the efficacy of mesobotox injection in improving skin lesions in patients with hidradenitis suppurativa Evaluating the effect of mesobotox injection on one side of the body compared to the contralateral side in patients with hidradenitis suppurativa receiving biologic therapy 2026-09-21 anticipated 30 Complete https://irct.ir/trial/91351 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this split-body trial, the allocation of the intervention side (right or left side of the body) to receive mesobotox or placebo is performed using block randomization generated by statistical software. Allocation concealment is ensured using sequentially numbered, opaque, sealed envelopes (SNOSE). Syringes containing mesobotox and normal saline with identical appearance and volume are prepared and coded by an independent person not involved in patient outcome assessment, Blinding description: In this split-body trial, the study is conducted in a single-blind manner where only the participant (patient) is blinded to the intervention side. Clinical lesion evaluations and outcome assessments are performed by the investigator physician, and no placebo is administered on the control side. 2 Hidradenitis Suppurativa. Intervention 1: Intervention group: Intradermal injection of botulinum toxin type A (mesobotox technique) into lesions and affected anatomical areas of hidradenitis suppurativa. Injections are administered intradermally in a single session using a fine needle. Intervention 2: No injection or placebo is administered on the contralateral control side, and the patient only receives routine standard care and follow-up clinical assessments for comparison. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the confidentiality of patients’ medical data
public Toomaj Shahverdi
Razi Skin Hospital, Razi Alley, Vahdat-e Eslami Square, Vahdat-e Eslami St., Tehran, Iran
Tehran Iran (Islamic Republic of) 1199663911 +98 21 5563 0553 drtoomjshahverdi@gmail.com Tehran University of Medical Sciences scientific Toomaj Shahverdi
Vahdate e Eslami Street
Tehran Iran (Islamic Republic of) 1199663911 +98 21 5563 0553 drtoomajshahverdi@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Age 18 years and older Definite diagnosis of moderate-to-severe hidradenitis suppurativa (Hurley stage II or III) Presence of bilateral and relatively symmetrical active inflammatory lesions Receiving a stable dose of biologic therapy for at least 12 weeks prior to study Informed consent to participate in the study no limit no limit Male Known hypersensitivity to botulinum toxin or any of its components Underlying neuromuscular disorders such as myasthenia gravis or Lambert-Eaton syndrome Pregnancy or lactation Active acute cutaneous infection or cellulitis at the injection sites Patient unwillingness to continue participation at any stage of the study L73.2 Hidradenitis suppurativa Treatment - Drugs Treatment - Drugs Intervention group: Intradermal injection of botulinum toxin type A (mesobotox technique) into lesions and affected anatomical areas of hidradenitis suppurativa. Injections are administered intradermally in a single session using a fine needle No injection or placebo is administered on the contralateral control side, and the patient only receives routine standard care and follow-up clinical assessments for comparison. Clinical response defined by Hidradenitis Suppurativa Clinical Response (HiSCR), which is at least a 50% reduction in total inflammatory nodule and abscess count with no increase in abscess or draining tunnel count. Timepoint: Before the intervention and 8 weeks later. Method of measurement: Clinical physical examination by a dermatologist to count inflammatory nodules, abscesses, and draining tunnels/fistulas, followed by calculation and evaluation of Hidradenitis Suppurativa Clinical Response (HiSCR) achievement. Tehran University of Medical Sciences Approved 2026-04-25 Ethics committee of Tehran University of Medical Sciences Tehran University of Medical Sciences, Central Building, Corner of Poursina St., Qods St., Enghelab Ave., Tehran Tehran Tehran Iran (Islamic Republic of)