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

Primary Purpose

Hyperhidrosis

Status
Unknown status
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Botox (onabotulinumtoxinA)
NeuroBloc/Myobloc (rimabotulinumtoxinB)
NaCl (placebo)
Sponsored by
Carl Swartling
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperhidrosis focused on measuring Palmar hyperhidrosis., Plantar hyperhidrosis., Inguinal (groins and buttocks) hyperhidrosis., Craniofacial hyperhidrosis., Truncal hyperhidrosis.

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Carl SwartlingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

Palmar hyperhidrosis, Botox (onabotulinumtoxinA)

Palmar hyperhidrosis, NaCl

Plantar hyperhidrosis, Botox (onabotulinumtoxinA)

Plantar hyperhidrosis, NaCl

Inguinal (groins/buttocks) hyperhidrosis, Botox (ona...)

Inguinal (groins/buttocks) hyperhidrosis, NaCl

Craniofacial hyperhidrosis, NeuroBloc/Myobloc (rima...)

Craniofacial hyperhidrosis, NaCl

Truncal hyperhidrosis, NeuroBloc/Myobloc (rimabotulinumtoxinB)

Truncal hyperhidrosis, NaCl

Arm Description

Solution for injection, individual dosing, maximum dose 400 units, single treatment session.

Solution for injection, individual dosing, injection volume corresponding to active comparator, single treatment session.

Solution for injection, individual dosing, maximum dose 400 units, single treatment session.

Solution for injection, individual dosing, injection volume corresponding to active comparator, single treatment session.

Solution for injection, individual dosing, maximum dose 400 units, single treatment session.

Solution for injection, individual dosing, injection volume corresponding to active comparator, single treatment session.

Solution for injection, individual dosing, maximum dose 2500 units, single treatment session.

Solution for injection, individual dosing, injection volume corresponding to active comparator, single treatment session.

Solution for injection, individual dosing, maximum dose 5000 units, single treatment session.

Solution for injection, individual dosing, injection volume corresponding to active comparator, single treatment session.

Outcomes

Primary Outcome Measures

DLQI (Dermatology Life Quality Index)
The primary endpoint is scores on DLQI-values at follow-up in the Btx A/B treatment groups when compared to the placebo groups.

Secondary Outcome Measures

AE (Adverse Events)
Safety by recording of reported adverse events (AE) by the patient at the clinic visits
Gravimetry
The amount of sweat is measured gravimetrically.
HDSS (Hyperhidrosis Disease Severity Scale)
Health outcome (EQ-5D)
LSAS-SR (Liebowitz Social Anxiety Scale-Self Report)
MADRS-S (Montgomery-Asberg Depression Rating Scale-Self report)
Global Assessment of Therapy
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.
DLQI (Dermatology Life Quality Index)

Full Information

First Posted
August 16, 2013
Last Updated
March 2, 2018
Sponsor
Carl Swartling
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1. Study Identification

Unique Protocol Identification Number
NCT01930604
Brief Title
Botulinum Toxin Treatment in Craniofacial, Inguinal, Palmar, Plantar and Truncal Hyperhidrosis
Official Title
Botulinum Toxin Treatment in Craniofacial, Inguinal, Palmar, Plantar and Truncal Hyperhidrosis, a Randomized, Double Blind, Placebo Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
October 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Carl Swartling

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperhidrosis
Keywords
Palmar hyperhidrosis., Plantar hyperhidrosis., Inguinal (groins and buttocks) hyperhidrosis., Craniofacial hyperhidrosis., Truncal hyperhidrosis.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
588 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Palmar hyperhidrosis, Botox (onabotulinumtoxinA)
Arm Type
Active Comparator
Arm Description
Solution for injection, individual dosing, maximum dose 400 units, single treatment session.
Arm Title
Palmar hyperhidrosis, NaCl
Arm Type
Placebo Comparator
Arm Description
Solution for injection, individual dosing, injection volume corresponding to active comparator, single treatment session.
Arm Title
Plantar hyperhidrosis, Botox (onabotulinumtoxinA)
Arm Type
Active Comparator
Arm Description
Solution for injection, individual dosing, maximum dose 400 units, single treatment session.
Arm Title
Plantar hyperhidrosis, NaCl
Arm Type
Placebo Comparator
Arm Description
Solution for injection, individual dosing, injection volume corresponding to active comparator, single treatment session.
Arm Title
Inguinal (groins/buttocks) hyperhidrosis, Botox (ona...)
Arm Type
Active Comparator
Arm Description
Solution for injection, individual dosing, maximum dose 400 units, single treatment session.
Arm Title
Inguinal (groins/buttocks) hyperhidrosis, NaCl
Arm Type
Placebo Comparator
Arm Description
Solution for injection, individual dosing, injection volume corresponding to active comparator, single treatment session.
Arm Title
Craniofacial hyperhidrosis, NeuroBloc/Myobloc (rima...)
Arm Type
Active Comparator
Arm Description
Solution for injection, individual dosing, maximum dose 2500 units, single treatment session.
Arm Title
Craniofacial hyperhidrosis, NaCl
Arm Type
Placebo Comparator
Arm Description
Solution for injection, individual dosing, injection volume corresponding to active comparator, single treatment session.
Arm Title
Truncal hyperhidrosis, NeuroBloc/Myobloc (rimabotulinumtoxinB)
Arm Type
Active Comparator
Arm Description
Solution for injection, individual dosing, maximum dose 5000 units, single treatment session.
Arm Title
Truncal hyperhidrosis, NaCl
Arm Type
Placebo Comparator
Arm Description
Solution for injection, individual dosing, injection volume corresponding to active comparator, single treatment session.
Intervention Type
Drug
Intervention Name(s)
Botox (onabotulinumtoxinA)
Intervention Type
Drug
Intervention Name(s)
NeuroBloc/Myobloc (rimabotulinumtoxinB)
Intervention Type
Drug
Intervention Name(s)
NaCl (placebo)
Primary Outcome Measure Information:
Title
DLQI (Dermatology Life Quality Index)
Description
The primary endpoint is scores on DLQI-values at follow-up in the Btx A/B treatment groups when compared to the placebo groups.
Time Frame
3±1 weeks after treatment
Secondary Outcome Measure Information:
Title
AE (Adverse Events)
Description
Safety by recording of reported adverse events (AE) by the patient at the clinic visits
Time Frame
Up to 12 weeks
Title
Gravimetry
Description
The amount of sweat is measured gravimetrically.
Time Frame
Before treatment and 3±1 weeks after treatment
Title
HDSS (Hyperhidrosis Disease Severity Scale)
Time Frame
Before treatment and 3±1 weeks after treatment
Title
Health outcome (EQ-5D)
Time Frame
Before treatment and 3±1 weeks after treatment
Title
LSAS-SR (Liebowitz Social Anxiety Scale-Self Report)
Time Frame
Before treatment and 3±1 weeks after treatment
Title
MADRS-S (Montgomery-Asberg Depression Rating Scale-Self report)
Time Frame
Before treatment and 3±1 weeks after treatment
Title
Global Assessment of Therapy
Description
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.
Time Frame
3±1 weeks after treatment
Title
DLQI (Dermatology Life Quality Index)
Time Frame
Before treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carl Swartling, MD, PhD
Phone
0046768534850
Email
carl.swartling@svettmottagningen.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl Swartling, MD, PhD
Organizational Affiliation
Hidrosis Clinic, Warfvinges väg 35, Stockholm, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carl Swartling
City
Stockholm
ZIP/Postal Code
SE-11251
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carl Swartling, MD, PhD
Phone
0046768534850
Email
carl.swartling@svettmottagningen.se
First Name & Middle Initial & Last Name & Degree
Carl Swartling, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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