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

Study Overview
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Brief Summary
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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.

Official Title
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Botulinum Toxin Treatment in Craniofacial, Inguinal, Palmar, Plantar and Truncal Hyperhidrosis, a Randomized, Double Blind, Placebo Controlled Study

Conditions
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Hyperhidrosis

Intervention / Treatment
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* Drug: Botox (onabotulinumtoxinA)
* Drug: NeuroBloc/Myobloc (rimabotulinumtoxinB)
* Drug: NaCl (placebo)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Palmar hyperhidrosis, Botox (onabotulinumtoxinA)<br>Solution for injection, individual dosing, maximum dose 400 units, single treatment session. | Drug: Botox (onabotulinumtoxinA)<br> <br> |
| Placebo Comparator: Palmar hyperhidrosis, NaCl<br>Solution for injection, individual dosing, injection volume corresponding to active comparator, single treatment session. | Drug: NaCl (placebo)<br> <br> |
| Active Comparator: Plantar hyperhidrosis, Botox (onabotulinumtoxinA)<br>Solution for injection, individual dosing, maximum dose 400 units, single treatment session. | Drug: Botox (onabotulinumtoxinA)<br> <br> |
| Placebo Comparator: Plantar hyperhidrosis, NaCl<br>Solution for injection, individual dosing, injection volume corresponding to active comparator, single treatment session. | Drug: NaCl (placebo)<br> <br> |
| Active Comparator: Inguinal (groins/buttocks) hyperhidrosis, Botox (ona...)<br>Solution for injection, individual dosing, maximum dose 400 units, single treatment session. | Drug: Botox (onabotulinumtoxinA)<br> <br> |
| Placebo Comparator: Inguinal (groins/buttocks) hyperhidrosis, NaCl<br>Solution for injection, individual dosing, injection volume corresponding to active comparator, single treatment session. | Drug: NaCl (placebo)<br> <br> |
| Active Comparator: Craniofacial hyperhidrosis, NeuroBloc/Myobloc (rima...)<br>Solution for injection, individual dosing, maximum dose 2500 units, single treatment session. | Drug: NeuroBloc/Myobloc (rimabotulinumtoxinB)<br> <br> |
| Placebo Comparator: Craniofacial hyperhidrosis, NaCl<br>Solution for injection, individual dosing, injection volume corresponding to active comparator, single treatment session. | Drug: NaCl (placebo)<br> <br> |
| Active Comparator: Truncal hyperhidrosis, NeuroBloc/Myobloc (rimabotulinumtoxinB)<br>Solution for injection, individual dosing, maximum dose 5000 units, single treatment session. | Drug: NeuroBloc/Myobloc (rimabotulinumtoxinB)<br> <br> |
| Placebo Comparator: Truncal hyperhidrosis, NaCl<br>Solution for injection, individual dosing, injection volume corresponding to active comparator, single treatment session. | Drug: NaCl (placebo)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AE (Adverse Events) | Safety by recording of reported adverse events (AE) by the patient at the clinic visits | Up to 12 weeks | 
| Gravimetry | The amount of sweat is measured gravimetrically. | 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 | 
| MADRS-S (Montgomery-Asberg Depression Rating Scale-Self report) |  | Before treatment and 3±1 weeks after treatment | 
| Global Assessment of Therapy | 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. | 3±1 weeks after treatment | 
| DLQI (Dermatology Life Quality Index) |  | Before treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Palmar hyperhidrosis., Plantar hyperhidrosis., Inguinal (groins and buttocks) hyperhidrosis., Craniofacial hyperhidrosis., Truncal hyperhidrosis.