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

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: Hyperhidrosis
• Intervention / Treatment: Drug: Botox (onabotulinumtoxinA); Drug: NaCl (placebo); Drug: NeuroBloc/Myobloc (rimabotulinumtoxinB)

• Study Type: Interventional
• Enrollment (Anticipated): 588
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Carl Swartling, MD, PhD; Phone Number: 0046768534850; Email: carl.swartling@svettmottagningen.se

Study Locations

• Sweden
  • Stockholm, Sweden, SE-11251
    • Recruiting
    • Carl Swartling
    • Contact: Carl Swartling, MD, PhD; Phone Number: 0046768534850; Email: carl.swartling@svettmottagningen.se
    • Principal Investigator: Carl Swartling, MD, PhD

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

10

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)	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)	Safety by recording of reported adverse events (AE) by the patient at the clinic visits	Up to 12 weeks
Gravimetry	The amount of sweat is measured gravimetrically.	Before treatment and 3±1 weeks after treatment
HDSS (Hyperhidrosis Disease Severity Scale)		Before treatment and 3±1 weeks after treatment
Health outcome (EQ-5D)		Before treatment and 3±1 weeks after treatment
LSAS-SR (Liebowitz Social Anxiety Scale-Self Report)		Before treatment and 3±1 weeks after treatment
MADRS-S (Montgomery-Asberg Depression Rating Scale-Self report)		Before treatment and 3±1 weeks after treatment
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.	3±1 weeks after treatment
DLQI (Dermatology Life Quality Index)		Before treatment

Collaborators and Investigators

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

Study record dates

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: Palmar hyperhidrosis.; Plantar hyperhidrosis.; Inguinal (groins and buttocks) hyperhidrosis.; Craniofacial hyperhidrosis.; Truncal hyperhidrosis.
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Hyperhidrosis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Anti-Dyskinesia Agents; Botulinum Toxins, Type A; abobotulinumtoxinA; rimabotulinumtoxinB
• Other Study ID Numbers: BTXHH11