FindTrial
Sign In

Unicentric Comparing Study of Suction Curettage With Standard BOTOX Injection in the Treatment of Patients With Essential Axillar Hyperhidrosis: Comparing of Efficacy, Duration of Effectiveness, and Adverse Events.

Unicentric Comparing Study of Suction Curettage With Standard BOTOX Injection in the Treatment of Patients With Essential Axillar Hyperhidrosis: Comparing of Efficacy, Duration of Effectiveness, and Adverse Events.

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00669474
Enrollment
25
Registered
2008-04-30
Start date
2009-06-30
Completion date
2011-08-31
Last updated
2015-06-04

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

Conditions

Essential Axillary Hyperhidrosis

Brief summary

Part 1: patients with essential hyperhidrosis are treated one time with suction curettage in both axillae. Part 2: patients with axillary hyperhidrosis receive one treatment with suction curettage in one axilla, and at the same time one treatment with BOTOX injections in the other axilla.

Interventions

PROCEDURESuction curettage

Suction curettage

DRUGTreatment with Botox

Treatment with Botox

Sponsors

Allergan
CollaboratorINDUSTRY
University Hospital, Ghent
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* 18 to 75 years * Persistent bilateral primary axillary hyperhidrosis * Hidrosis interferes with daily activities of patient * Gravimetrically minimal 50 mg spontaneous sweat production in each axilla, measured during 5 minutes in room temperature in calm condition * signed informed consent * patient can and shall continue the trial until the end, and will follow the instructions correcly * women in reproductive period had a pregnancy test

Exclusion criteria

* Medical condition that can be dangerous by treatment with BOTOX, including myastenia gravis, Lambert-Eaton syndrome, ALS, and each other disease that can interfere with the neuromuscular function * Secundary hyperhidrosis (for example secundary on hyperthyroid problems, lymfoma, malaria) * Known allergy against study medication, his components, local anesthesia or iodium * Use of aminoglycosids, curare-like products, or other products which can interfere with the neuromuscular function during the study * Use of therapy for hyperhidrosis with Aluminium chlorid during the study * Infection or skin disease in the area to treat * Participation in an other therapeutic study on the same time * Botuline toxine treatment in the last 4 months * Women who can or who want to become pregnant * Women in reproductive period who don't use the appropriate contraception * Patients in a situation of which the researchers decide it can be dangerous, or can interfere with the study

Design outcomes

Primary

MeasureTime frame
Effectiviness and duration of effect of both treatments1 year

Secondary

MeasureTime frame
Adverse events of both treatments1 year

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026