Clinical trial NCT01930604: Botulinum Toxin Treatment in Craniofacial, Inguinal, Palmar, Plantar and Truncal Hyperhidrosis
Official title: Botulinum Toxin Treatment in Craniofacial, Inguinal, Palmar, Plantar and Truncal Hyperhidrosis, a Randomized, Double Blind, Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hyperhidrosis
Keywords: Palmar hyperhidrosis.
Plantar hyperhidrosis.
Inguinal (groins and buttocks) hyperhidrosis.
Craniofacial hyperhidrosis.
Truncal hyperhidrosis.
Lead sponsor: Hidrosis Clinic, Stockholm, Sweden
Sponsor class: OTHER
First posted: 2013-08-29
Enrollment: 588
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: DLQI (Dermatology Life Quality Index)
timeFrame: 3±1 weeks after treatment
Secondary outcomes:
measure: AE (Adverse Events)
timeFrame: Up to 12 weeks
measure: Gravimetry
timeFrame: Before treatment and 3±1 weeks after treatment
measure: HDSS (Hyperhidrosis Disease Severity Scale)
timeFrame: Before treatment and 3±1 weeks after treatment
measure: Health outcome (EQ-5D)
timeFrame: Before treatment and 3±1 weeks after treatment
measure: LSAS-SR (Liebowitz Social Anxiety Scale-Self Report)
timeFrame: Before treatment and 3±1 weeks after treatment
measure: MADRS-S (Montgomery-Asberg Depression Rating Scale-Self report)
timeFrame: Before treatment and 3±1 weeks after treatment
measure: Global Assessment of Therapy
timeFrame: 3±1 weeks after treatment
measure: DLQI (Dermatology Life Quality Index)
timeFrame: Before treatment
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Carl Swartling
Study officials:
affiliation: Hidrosis Clinic, Warfvinges väg 35, Stockholm, Sweden
name: Carl Swartling, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: