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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2013 by Hidrosis Clinic, Stockholm, Sweden
Sponsor:
Information provided by (Responsible Party):
Carl Swartling, Hidrosis Clinic, Stockholm, Sweden
ClinicalTrials.gov Identifier:
NCT01930604
First received: August 16, 2013
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Hidrosis Clinic, Stockholm, Sweden:

Primary Outcome Measures:
  • DLQI (Dermatology Life Quality Index) [ Time Frame: 3±1 weeks after treatment ] [ Designated as safety issue: No ]
    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) [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: Yes ]
    Safety by recording of reported adverse events (AE) by the patient at the clinic visits

  • Gravimetry [ Time Frame: Before treatment and 3±1 weeks after treatment ] [ Designated as safety issue: No ]
    The amount of sweat is measured gravimetrically.

  • HDSS (Hyperhidrosis Disease Severity Scale) [ Time Frame: Before treatment and 3±1 weeks after treatment ] [ Designated as safety issue: No ]
  • Health outcome (EQ-5D) [ Time Frame: Before treatment and 3±1 weeks after treatment ] [ Designated as safety issue: No ]
  • LSAS-SR (Liebowitz Social Anxiety Scale-Self Report) [ Time Frame: Before treatment and 3±1 weeks after treatment ] [ Designated as safety issue: No ]
  • MADRS-S (Montgomery-Asberg Depression Rating Scale-Self report) [ Time Frame: Before treatment and 3±1 weeks after treatment ] [ Designated as safety issue: No ]
  • Global Assessment of Therapy [ Time Frame: 3±1 weeks after treatment ] [ Designated as safety issue: No ]
    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) [ Time Frame: Before treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 274
Study Start Date: September 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Botox (onabotulinumtoxinA)

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

Botox will be compared to placebo in palmar hyperhidrosis, plantar hyperhidrosis and inguinal (groins, buttocks) hyperhidrosis.

Drug: Botox (onabotulinumtoxinA) Drug: NaCl (placebo)
Active Comparator: NeuroBloc/Myobloc (rimabotulinumtoxinB)

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

NeuroBloc/Myobloc will be compared to placebo in craniofacial hyperhidrosis and truncal hyperhidrosis.

Drug: NeuroBloc/Myobloc (rimabotulinumtoxinB) Drug: NaCl (placebo)
Placebo Comparator: NaCl
Solution for injection, individual dosing, injection volume corresponding to active comparator, single treatment session.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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/or HDSS-score ≥ 3

Exclusion Criteria:

  • Contraindication to Btx
  • Use of aminoglycosides, tetracyklines , 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01930604

Contacts
Contact: Carl Swartling, MD, PhD 0046709283434 carl.swartling@svettmottagningen.se

Locations
Sweden
Carl Swartling Not yet recruiting
Stockholm, Sweden, SE-11219
Contact: Carl Swartling, MD, PhD    0046709283434    carl.swartling@svettmottagningen.se   
Principal Investigator: Carl Swartling, MD, PhD         
Sponsors and Collaborators
Carl Swartling
Investigators
Principal Investigator: Carl Swartling, MD, PhD Hidrosis Clinic, S:t Görans Hospital, Stockholm, Sweden
  More Information

No publications provided

Responsible Party: Carl Swartling, MD, PhD, Hidrosis Clinic, Stockholm, Sweden
ClinicalTrials.gov Identifier: NCT01930604     History of Changes
Other Study ID Numbers: BTXHH11
Study First Received: August 16, 2013
Last Updated: August 28, 2013
Health Authority: Sweden: Medical Products Agency

Keywords provided by Hidrosis Clinic, Stockholm, Sweden:
Palmar hyperhidrosis.
Plantar hyperhidrosis.
Inguinal (groins and buttocks) hyperhidrosis.
Craniofacial hyperhidrosis.
Truncal hyperhidrosis.

Additional relevant MeSH terms:
Hyperhidrosis
Sweat Gland Diseases
Skin Diseases
RimabotulinumtoxinB
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014