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.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Essential Axillary Hyperhidrosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Suction curettage

Group Type OTHER

Suction curettage

Intervention Type PROCEDURE

Suction curettage

2

Treatment with Botox

Group Type ACTIVE_COMPARATOR

Treatment with Botox

Intervention Type DRUG

Treatment with Botox

Interventions

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Suction curettage

Intervention Type PROCEDURE

Treatment with Botox

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No