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

Carl Swartling

Status and phase: Unknown; Phase 2

Conditions: Hyperhidrosis

Treatments: Drug: NeuroBloc/Myobloc (rimabotulinumtoxinB); Drug: NaCl (placebo); Drug: Botox (onabotulinumtoxinA)

Study type: Interventional

Funder types: Other

Identifiers

NCT01930604

BTXHH11

Details and patient eligibility

About

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.

Enrollment: 588 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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588 participants in 10 patient groups, including a placebo group

Palmar hyperhidrosis, Botox (onabotulinumtoxinA)

Active Comparator group

Description:

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

Treatment:

Drug: Botox (onabotulinumtoxinA)

Palmar hyperhidrosis, NaCl

Placebo Comparator group

Description:

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

Treatment:

Drug: NaCl (placebo)

Plantar hyperhidrosis, Botox (onabotulinumtoxinA)

Active Comparator group

Description:

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

Treatment:

Drug: Botox (onabotulinumtoxinA)

Plantar hyperhidrosis, NaCl

Placebo Comparator group

Description:

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

Treatment:

Drug: NaCl (placebo)

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

Active Comparator group

Description:

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

Treatment:

Drug: Botox (onabotulinumtoxinA)

Inguinal (groins/buttocks) hyperhidrosis, NaCl

Placebo Comparator group

Description:

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

Treatment:

Drug: NaCl (placebo)

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

Active Comparator group

Description:

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

Treatment:

Drug: NeuroBloc/Myobloc (rimabotulinumtoxinB)

Craniofacial hyperhidrosis, NaCl

Placebo Comparator group

Description:

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

Treatment:

Drug: NaCl (placebo)

Truncal hyperhidrosis, NeuroBloc/Myobloc (rimabotulinumtoxinB)

Active Comparator group

Description:

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

Treatment:

Drug: NeuroBloc/Myobloc (rimabotulinumtoxinB)

Truncal hyperhidrosis, NaCl

Placebo Comparator group

Description:

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

Treatment:

Drug: NaCl (placebo)