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

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ClinicalTrials.gov Identifier: NCT01930604
Recruitment Status : Recruiting
First Posted : August 29, 2013
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
Carl Swartling, Hidrosis Clinic, Stockholm, Sweden

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 Type : Interventional  (Clinical Trial)
Estimated 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 : September 2013
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

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)



Primary Outcome Measures :
  1. DLQI (Dermatology Life Quality Index) [ Time Frame: 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 :
  1. AE (Adverse Events) [ Time Frame: Up to 12 weeks ]
    Safety by recording of reported adverse events (AE) by the patient at the clinic visits

  2. Gravimetry [ Time Frame: Before treatment and 3±1 weeks after treatment ]
    The amount of sweat is measured gravimetrically.

  3. HDSS (Hyperhidrosis Disease Severity Scale) [ Time Frame: Before treatment and 3±1 weeks after treatment ]
  4. Health outcome (EQ-5D) [ Time Frame: Before treatment and 3±1 weeks after treatment ]
  5. LSAS-SR (Liebowitz Social Anxiety Scale-Self Report) [ Time Frame: Before treatment and 3±1 weeks after treatment ]
  6. MADRS-S (Montgomery-Asberg Depression Rating Scale-Self report) [ Time Frame: Before treatment and 3±1 weeks after treatment ]
  7. Global Assessment of Therapy [ Time Frame: 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.

  8. DLQI (Dermatology Life Quality Index) [ Time Frame: Before treatment ]


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01930604


Contacts
Contact: Carl Swartling, MD, PhD 0046768534850 carl.swartling@svettmottagningen.se

Locations
Sweden
Carl Swartling Recruiting
Stockholm, Sweden, SE-11251
Contact: Carl Swartling, MD, PhD    0046768534850    carl.swartling@svettmottagningen.se   
Principal Investigator: Carl Swartling, MD, PhD         
Sponsors and Collaborators
Carl Swartling
Investigators
Principal Investigator: Carl Swartling, MD, PhD Hidrosis Clinic, Warfvinges väg 35, Stockholm, Sweden

Responsible Party: Carl Swartling, MD, PhD, Hidrosis Clinic, Stockholm, Sweden
ClinicalTrials.gov Identifier: NCT01930604     History of Changes
Other Study ID Numbers: BTXHH11
First Posted: August 29, 2013    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018

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

Additional relevant MeSH terms:
Sweat Gland Diseases
Hyperhidrosis
Skin Diseases
Botulinum Toxins
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
rimabotulinumtoxinB
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Anti-Dyskinesia Agents