UnknownPhase 2

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

Sweden588 participantsStarted 2013-09

Plain-language 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.

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

DLQI (Dermatology Life Quality Index)

Timeframe: 3±1 weeks after treatment

Trial details

NCT IDNCT01930604

SponsorCarl Swartling

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-10

Contact for this trial

Carl Swartling, MD, PhD

0046768534850 carl.swartling@svettmottagningen.se

View on ClinicalTrials.gov More Hyperhidrosis trials