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Investigation of the effect of Masport on Excessive Underarm Sweating

A Double blind, Randomized, Comparative study of the Efficacy and Safety of Botulinum Toxin type A Masport with commercial brand Dysport in the treatment of Primary Axillary Hyperhidrosis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220620055230N1
Enrollment
15
Registered
2022-09-26
Start date
2022-09-06
Completion date
Unknown
Last updated
2022-11-21

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

Conditions

Primary Axillary Hyperhydrosis. Primary focal hyperhidrosis, axilla

Interventions

Intervention 1: Intervention group:All 15 participants in this study will be injected with 165 IU botulinum toxin type A Masport (each vial contains 500 IU of botulinum toxin type A that will be dilut

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Adults aged between 18 to 65 years who have a sweating rate of 50 mg per minute or higher.

Exclusion criteria

Exclusion criteria: secondary Hyperhidrosis due to systemic problems. Pregnancy Lactation people who have taken Aminoglycosides in the last three weeks. people who have had botulinum toxin injection in the past year. people with Neuromuscellar diseases

Design outcomes

Primary

MeasureTime frame
The score of sweating rate in the questionnaire of "Hyperhidrosis disease severity scale" by patients. Timepoint: scoring of the amount of sweating will be done on day 0 (before the stat of the study), 14, 90 and 180 days after botulinum toxin injection. Method of measurement: The questionnaire "Hyperhidrosis disease severity scale".;Sweating rate based on Gravimetry test. Timepoint: measurement of the sweating will be done on day 0 (before the stat of the study), 14, 90 and 180 days after botulinum toxin injection. Method of measurement: Using a digital scale.;Occurrence of the side effects, The time of onset and duration of the complication. Timepoint: Patients will be able to report occurrence of the side effects throughout the study, but they will be asked specifically on 14th, 90th and 180th after Botulinum Toxin injection. Method of measurement: Statements of patients.

Countries

Iran (Islamic Republic of)

Contacts

Public Contactkamand Hedayat

Pasture Institute of Iran

kamandhedayat@yahoo.com+98 21 6695 3311

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026