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
To assess the efficacy and safety of intradermal botulinum toxin injection in hidradenitis suppurativa compared to non-interventional control in a split-body design
Design
Randomized, single-blind, within-person controlled, split-body clinical trial, phase 2/3, conducted on 20 patients with hidradenitis suppurativa. Random allocation of the intervention side is performed using block randomization with allocation concealment using sealed envelopes.
Settings and conduct
This study is conducted at the dermatology clinic of Razi Hospital. Eligible patients are enrolled after obtaining written informed consent. In each patient, one side is randomly assigned to receive intradermal mesobotox injection, while the contralateral side serves as a non-interventional control. Patients are blinded to the allocated intervention side. Clinical outcomes including treatment response, pain intensity and quality of life are evaluated at baseline, 8 weeks post-intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age ≥18; bilateral symmetrical hidradenitis suppurativa; written informed consent. Exclusion criteria: Toxin hypersensitivity; neuromuscular disorders; pregnancy/lactation; prior botulinum toxin or surgery in the area (<6 months); severe active infection needing urgent drainage
Intervention groups
Intervention group: Intradermal injection of mesobotox into hidradenitis suppurativa lesions and affected areas. Control group: No intervention or injection is administered on the contralateral side.
Main outcome variables
At least a 50% reduction in the total inflammatory nodule and abscess count, with no increase in the number of abscesses or draining fistulas. Time points: Baseline 8, weeks post-intervention assessed by clinical examination.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241115063720N2
Registration date:2026-09-29, 1405/07/07
Registration timing:registered_while_recruiting
Last update:2026-09-29, 1405/07/07
Update count:0
Registration date
2026-09-29, 1405/07/07
Registrant information
Name
Toomaj Shahverdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 4230 2523
Email address
drtoomajshahverdi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-09-21, 1405/06/30
Expected recruitment end date
2026-10-12, 1405/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Evaluating the efficacy of mesobotox injection in improving skin lesions in patients with hidradenitis suppurativa
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
No age limit
Gender
Male
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Central Building, Corner of Poursina St., Qods St., Enghelab Ave., Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۵۳۷۶۱
Approval date
2026-04-25, 1405/02/05
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1405.059
Health conditions studied
1
Description of health condition studied
Hidradenitis Suppurativa
ICD-10 code
L73.2
ICD-10 code description
Hidradenitis suppurativa
Primary outcomes
1
Description
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.
Secondary outcomes
empty
Intervention groups
1
Description
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
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Toomaj Shahverdi
Street address
Vahdate e Eslami Street
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0553
Email
drtoomajshahverdi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ramin Kordi
Street address
Vice-Chancellor for Research and Technology, Tehran University of Medical Sciences, Central Building, Corner of Poursina St., Qods St., Enghelab Ave., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۵۳۷۶۱
Phone
+98 21 8163 3000
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?