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

Hyperhidrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01930604
• Other study ID #: BTXHH11
• Status: Recruiting
• Phase: Phase 2
• First received: August 16, 2013
• Last updated: March 2, 2018
• Start date: September 2013
• Est. completion date: October 2019

Study information

• Verified date: March 2018
• Source: Hidrosis Clinic, Stockholm, Sweden
• Contact: Carl Swartling, MD, PhD
• Phone: 0046768534850
• Email: carl.swartling[@]svettmottagningen.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 588
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperhidrosis

Intervention

Drug:
• Botox (onabotulinumtoxinA)

• NeuroBloc/Myobloc (rimabotulinumtoxinB)

• NaCl (placebo)

Locations

Country	Name	City	State
Sweden	Carl Swartling	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Carl Swartling

Country where clinical trial is conducted

Sweden, 

Outcome

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