Botulinum Toxin Treatment in Craniofacial, Inguinal, Palmar, Plantar and Truncal Hyperhidrosis

March 2, 2018 updated by: Carl Swartling

Botulinum Toxin Treatment in Craniofacial, Inguinal, Palmar, Plantar and Truncal Hyperhidrosis, a Randomized, Double Blind, Placebo Controlled Study

Hyperhidrosis is defined as excessive sweating and affects about 2.8 % of the population.

It has been shown to have a deleterious effect on the quality of life measured using the Dermatology Life Quality Index (DLQI) which is one of the most widely used dermatology-specific quality of life instruments. This is comparable to the effect on quality of life in patients with severe psoriasis of the skin as well as to nodulocystic acne patients before treatment with oral isotretinoin.

The clinical effect of Botulinum Toxin (Btx) A has been established in three randomized controlled trials (RCT) in axillary hyperhidrosis. One RCT has indicated a positive effect in palmar hyperhidrosis. Although there is increasing evidence that Btx A and B have a similar effect on hyperhidrosis of other parts of the body (ie hyperhidrosis of the face, trunk, groin and feet) which is reported in case-reports and open studies there is still a great need for more controlled studies. This is why we will carry out this randomized, double-blind, placebo-controlled study to investigate the clinical effect and safety of Btx A in palmar, plantar and inguinal (groins/buttocks) hyperhidrosis and the clinical effect and safety of Btx B in craniofacial and truncal hyperhidrosis, respectively. Besides using the DLQI instrument we will also study Btx A/B to elucidate the impact of this treatment on quality of life using a generic instrument, the effect on anxiety and depressive symptoms, sweating, and patients´global assessment of therapy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

588

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, SE-11251
        • Recruiting
        • Carl Swartling
        • Contact:
        • Principal Investigator:
          • Carl Swartling, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed consent received from patient
  • Informed consent received from patient´s parents (when patient < 18 years)
  • Hyperhidrosis of the head, trunk, groins/buttocks, hands or feet
  • Age > 16 years
  • Patients must be previously untreated with Btx A/B

  • If female, patient is post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control (i.e. a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom*) throughout the study. If male with a female partner of childbearing potential, willing to use an acceptable method of birth control for the study duration of the study, for both female and male, acceptable birth control must be used for at least 3 months after the last dose of study medication.

    * A condom alone is not considered an acceptable method for birth control. Two barrier methods only are not considered an acceptable method of birth control.

  • Patients must have DLQI-score ≥ 10 and HDSS-score ≥ 3

Exclusion Criteria:

  • Contraindication to Btx
  • Use of aminoglycosides, tetracyclines , spectinomycin, lincomycin, polymyxin or muscle relaxants
  • Pregnancy or lactation
  • Patients unwilling to meet the requirements of the protocol
  • Other medical or social reasons for exclusion at the discretion of the Investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Palmar hyperhidrosis, Botox (onabotulinumtoxinA)
Solution for injection, individual dosing, maximum dose 400 units, single treatment session.
Drug: Botox (onabotulinumtoxinA)
Placebo Comparator: Palmar hyperhidrosis, NaCl
Solution for injection, individual dosing, injection volume corresponding to active comparator, single treatment session.
Drug: NaCl (placebo)
Active Comparator: Plantar hyperhidrosis, Botox (onabotulinumtoxinA)
Solution for injection, individual dosing, maximum dose 400 units, single treatment session.
Drug: Botox (onabotulinumtoxinA)
Placebo Comparator: Plantar hyperhidrosis, NaCl
Solution for injection, individual dosing, injection volume corresponding to active comparator, single treatment session.
Drug: NaCl (placebo)
Active Comparator: Inguinal (groins/buttocks) hyperhidrosis, Botox (ona...)
Solution for injection, individual dosing, maximum dose 400 units, single treatment session.
Drug: Botox (onabotulinumtoxinA)
Placebo Comparator: Inguinal (groins/buttocks) hyperhidrosis, NaCl
Solution for injection, individual dosing, injection volume corresponding to active comparator, single treatment session.
Drug: NaCl (placebo)
Active Comparator: Craniofacial hyperhidrosis, NeuroBloc/Myobloc (rima...)
Solution for injection, individual dosing, maximum dose 2500 units, single treatment session.
Drug: NeuroBloc/Myobloc (rimabotulinumtoxinB)
Placebo Comparator: Craniofacial hyperhidrosis, NaCl
Solution for injection, individual dosing, injection volume corresponding to active comparator, single treatment session.
Drug: NaCl (placebo)
Active Comparator: Truncal hyperhidrosis, NeuroBloc/Myobloc (rimabotulinumtoxinB)
Solution for injection, individual dosing, maximum dose 5000 units, single treatment session.
Drug: NeuroBloc/Myobloc (rimabotulinumtoxinB)
Placebo Comparator: Truncal hyperhidrosis, NaCl
Solution for injection, individual dosing, injection volume corresponding to active comparator, single treatment session.
Drug: NaCl (placebo)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DLQI (Dermatology Life Quality Index)
Time Frame: 3±1 weeks after treatment
The primary endpoint is scores on DLQI-values at follow-up in the Btx A/B treatment groups when compared to the placebo groups.
3±1 weeks after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AE (Adverse Events)
Time Frame: Up to 12 weeks
Safety by recording of reported adverse events (AE) by the patient at the clinic visits
Up to 12 weeks
Gravimetry
Time Frame: Before treatment and 3±1 weeks after treatment
The amount of sweat is measured gravimetrically.
Before treatment and 3±1 weeks after treatment
HDSS (Hyperhidrosis Disease Severity Scale)
Time Frame: Before treatment and 3±1 weeks after treatment
Before treatment and 3±1 weeks after treatment
Health outcome (EQ-5D)
Time Frame: Before treatment and 3±1 weeks after treatment
Before treatment and 3±1 weeks after treatment
LSAS-SR (Liebowitz Social Anxiety Scale-Self Report)
Time Frame: Before treatment and 3±1 weeks after treatment
Before treatment and 3±1 weeks after treatment
MADRS-S (Montgomery-Asberg Depression Rating Scale-Self report)
Time Frame: Before treatment and 3±1 weeks after treatment
Before treatment and 3±1 weeks after treatment
Global Assessment of Therapy
Time Frame: 3±1 weeks after treatment
The patient will be asked at the follow-up visit (3±1 weeks after treatment) to give his/her subjective opinion and rate the effect of the treatment using a scale ranging from 1-5.
3±1 weeks after treatment
DLQI (Dermatology Life Quality Index)
Time Frame: Before treatment
Before treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carl Swartling

Investigators

  • Principal Investigator: Carl Swartling, MD, PhD, Hidrosis Clinic, Warfvinges väg 35, Stockholm, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

August 16, 2013

First Submitted That Met QC Criteria

August 28, 2013

First Posted (Estimate)

August 29, 2013

Study Record Updates

Last Update Posted (Actual)

March 5, 2018

Last Update Submitted That Met QC Criteria

March 2, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BTXHH11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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