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

NCT ID: NCT01930604

Last Updated: 2018-03-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 588 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2019-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Palmar hyperhidrosis, Botox (onabotulinumtoxinA)

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

Group Type: ACTIVE_COMPARATOR

Botox (onabotulinumtoxinA)

Intervention Type: DRUG

Palmar hyperhidrosis, NaCl

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

Group Type: PLACEBO_COMPARATOR

NaCl (placebo)

Intervention Type: DRUG

Plantar hyperhidrosis, Botox (onabotulinumtoxinA)

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

Group Type: ACTIVE_COMPARATOR

Botox (onabotulinumtoxinA)

Intervention Type: DRUG

Plantar hyperhidrosis, NaCl

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

Group Type: PLACEBO_COMPARATOR

NaCl (placebo)

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

Botox (onabotulinumtoxinA)

Intervention Type: DRUG

Inguinal (groins/buttocks) hyperhidrosis, NaCl

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

Group Type: PLACEBO_COMPARATOR

NaCl (placebo)

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

NeuroBloc/Myobloc (rimabotulinumtoxinB)

Intervention Type: DRUG

Craniofacial hyperhidrosis, NaCl

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

Group Type: PLACEBO_COMPARATOR

NaCl (placebo)

Intervention Type: DRUG

Truncal hyperhidrosis, NeuroBloc/Myobloc (rimabotulinumtoxinB)

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

Group Type: ACTIVE_COMPARATOR

NeuroBloc/Myobloc (rimabotulinumtoxinB)

Intervention Type: DRUG

Truncal hyperhidrosis, NaCl

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

Group Type: PLACEBO_COMPARATOR

NaCl (placebo)

Intervention Type: DRUG

Interventions

Botox (onabotulinumtoxinA)

Intervention Type: DRUG

NeuroBloc/Myobloc (rimabotulinumtoxinB)

Intervention Type: DRUG

NaCl (placebo)

Intervention Type: DRUG

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carl Swartling

OTHER

Sponsor Role: lead

Responsible Party

Carl Swartling

MD, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Carl Swartling, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hidrosis Clinic, Warfvinges väg 35, Stockholm, Sweden

Locations

Carl Swartling

Stockholm, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Carl Swartling, MD, PhD

Role: CONTACT

carl.swartling@svettmottagningen.se

0046768534850

Facility Contacts

Carl Swartling, MD, PhD

Role: primary

carl.swartling@svettmottagningen.se

0046768534850

Other Identifiers

BTXHH11

Identifier Type: -

Identifier Source: org_study_id