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

NCT01930604 | Unknown Phase 2 DMC

• 1 other identifier: BTXHH11
• Study Type: interventional
• Target: 588
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperhidrosis

Keywords

Palmar hyperhidrosis.; Plantar hyperhidrosis.; Inguinal (groins and buttocks) hyperhidrosis.; Craniofacial hyperhidrosis.; Truncal hyperhidrosis.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• AE (Adverse Events)

  Up to 12 weeks

• Gravimetry

  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

Study Arms (10)

Palmar hyperhidrosis, Botox (onabotulinumtoxinA)

ACTIVE COMPARATOR

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

Drug: Botox (onabotulinumtoxinA)

Palmar hyperhidrosis, NaCl

PLACEBO COMPARATOR

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

Drug: NaCl (placebo)

Plantar hyperhidrosis, Botox (onabotulinumtoxinA)

ACTIVE COMPARATOR

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

Drug: Botox (onabotulinumtoxinA)

Plantar hyperhidrosis, NaCl

PLACEBO COMPARATOR

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

Drug: NaCl (placebo)

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

ACTIVE COMPARATOR

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

Drug: Botox (onabotulinumtoxinA)

Inguinal (groins/buttocks) hyperhidrosis, NaCl

PLACEBO COMPARATOR

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

Drug: NaCl (placebo)

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

ACTIVE COMPARATOR

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

Drug: NeuroBloc/Myobloc (rimabotulinumtoxinB)

Craniofacial hyperhidrosis, NaCl

PLACEBO COMPARATOR

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

Drug: NaCl (placebo)

Truncal hyperhidrosis, NeuroBloc/Myobloc (rimabotulinumtoxinB)

ACTIVE COMPARATOR

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

Drug: NeuroBloc/Myobloc (rimabotulinumtoxinB)

Truncal hyperhidrosis, NaCl

PLACEBO COMPARATOR

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

Drug: NaCl (placebo)

Interventions

Botox (onabotulinumtoxinA) DRUG

Inguinal (groins/buttocks) hyperhidrosis, Botox (ona...); Palmar hyperhidrosis, Botox (onabotulinumtoxinA); Plantar hyperhidrosis, Botox (onabotulinumtoxinA)

NeuroBloc/Myobloc (rimabotulinumtoxinB) DRUG

Craniofacial hyperhidrosis, NeuroBloc/Myobloc (rima...); Truncal hyperhidrosis, NeuroBloc/Myobloc (rimabotulinumtoxinB)

NaCl (placebo) DRUG

Craniofacial hyperhidrosis, NaCl; Inguinal (groins/buttocks) hyperhidrosis, NaCl; Palmar hyperhidrosis, NaCl; Plantar hyperhidrosis, NaCl; Truncal hyperhidrosis, NaCl

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Carl Swartling: lead

Study Sites (1)

Carl Swartling

Stockholm, SE-11251, Sweden

RECRUITING

MeSH Terms

Conditions

Hyperhidrosis

Interventions

Botulinum Toxins, Type A; rimabotulinumtoxinB

Condition Hierarchy (Ancestors)

Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Carl Swartling, MD, PhD

  Hidrosis Clinic, Warfvinges väg 35, Stockholm, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carl Swartling, MD, PhD

CONTACT

0046768534850; carl.swartling@svettmottagningen.se

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 16, 2013
• First Posted: August 29, 2013
• Study Start: September 1, 2013
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: March 5, 2018

Record last verified: 2018-03

Locations

SE (1)