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

Sponsor

Carl Swartling (Other)

Overall Status

Unknown status

CT.gov ID

NCT01930604

Collaborator

(none)

588

Enrollment

Location

Arms

Duration (Months)

8.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperhidrosis	Drug: Botox (onabotulinumtoxinA) Drug: NeuroBloc/Myobloc (rimabotulinumtoxinB) Drug: NaCl (placebo)	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

588 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2013

Anticipated Primary Completion Date :

Oct 1, 2019

Anticipated Study Completion Date :

Oct 1, 2019

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

DLQI (Dermatology Life Quality Index) [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.

Secondary Outcome Measures

AE (Adverse Events) [Up to 12 weeks]
Safety by recording of reported adverse events (AE) by the patient at the clinic visits
Gravimetry [Before treatment and 3±1 weeks after treatment]
The amount of sweat is measured gravimetrically.
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 [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.
DLQI (Dermatology Life Quality Index) [Before treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts 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