HyperhidrosisPhase 2NCT01930604
Botulinum Toxin Treatment in Craniofacial, Inguinal, Palmar, Plantar and Truncal Hyperhidrosis
A Phase 2 study testing Botox (onabotulinumtoxinA) and NeuroBloc/Myobloc (rimabotulinumtoxinB) in people with Hyperhidrosis, run by Carl Swartling at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hyperhidrosis
- What is being tested?
- Botox (onabotulinumtoxinA) and NeuroBloc/Myobloc (rimabotulinumtoxinB)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 588 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2013to Oct 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Carl Swartling
Stockholm, SE-11251
Carl Swartling, MD, PhD, 0046768534850, carl.swartling@svettmottagningen.se
Carl Swartling, MD, PhD
About this study
Official title: Botulinum Toxin Treatment in Craniofacial, Inguinal, Palmar, Plantar and Truncal Hyperhidrosis, a Randomized, Double Blind, Placebo Controlled Study
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.
- Conditions
- Hyperhidrosis
- Being tested
- Botox (onabotulinumtoxinA), NeuroBloc/Myobloc (rimabotulinumtoxinB), NaCl (placebo)
- Keywords
- Palmar hyperhidrosis., Plantar hyperhidrosis., Inguinal (groins and buttocks) hyperhidrosis., Craniofacial hyperhidrosis., Truncal hyperhidrosis.
- Medical subject headings
- Hyperhidrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botox (onabotulinumtoxinA)Drug
NeuroBloc/Myobloc (rimabotulinumtoxinB)Drug
NaCl (placebo)Drug
| Study group | Role | What they receive |
|---|---|---|
| Palmar hyperhidrosis, Botox (onabotulinumtoxinA) | Active comparator | Solution for injection, individual dosing, maximum dose 400 units, single treatment session. Receives: Drug: Botox (onabotulinumtoxinA) |
| Palmar hyperhidrosis, NaCl | Placebo comparator | Solution for injection, individual dosing, injection volume corresponding to active comparator, single treatment session. Receives: Drug: NaCl (placebo) |
| Plantar hyperhidrosis, Botox (onabotulinumtoxinA) | Active comparator | Solution for injection, individual dosing, maximum dose 400 units, single treatment session. Receives: Drug: Botox (onabotulinumtoxinA) |
| Plantar hyperhidrosis, NaCl | Placebo comparator | Solution for injection, individual dosing, injection volume corresponding to active comparator, single treatment session. Receives: Drug: NaCl (placebo) |
| Inguinal (groins/buttocks) hyperhidrosis, Botox (ona...) | Active comparator | Solution for injection, individual dosing, maximum dose 400 units, single treatment session. Receives: Drug: Botox (onabotulinumtoxinA) |
| Inguinal (groins/buttocks) hyperhidrosis, NaCl | Placebo comparator | Solution for injection, individual dosing, injection volume corresponding to active comparator, single treatment session. Receives: Drug: NaCl (placebo) |
| Craniofacial hyperhidrosis, NeuroBloc/Myobloc (rima...) | Active comparator | Solution for injection, individual dosing, maximum dose 2500 units, single treatment session. Receives: Drug: NeuroBloc/Myobloc (rimabotulinumtoxinB) |
| Craniofacial hyperhidrosis, NaCl | Placebo comparator | Solution for injection, individual dosing, injection volume corresponding to active comparator, single treatment session. Receives: Drug: NaCl (placebo) |
| Truncal hyperhidrosis, NeuroBloc/Myobloc (rimabotulinumtoxinB) | Active comparator | Solution for injection, individual dosing, maximum dose 5000 units, single treatment session. Receives: Drug: NeuroBloc/Myobloc (rimabotulinumtoxinB) |
| Truncal hyperhidrosis, NaCl | Placebo comparator | Solution for injection, individual dosing, injection volume corresponding to active comparator, single treatment session. Receives: Drug: NaCl (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3±1 weeks after treatment
Secondary outcomes (8)
AE (Adverse Events)
Safety by recording of reported adverse events (AE) by the patient at the clinic visits
Measured: Up to 12 weeks
Gravimetry
The amount of sweat is measured gravimetrically.
Measured: Before treatment and 3±1 weeks after treatment
HDSS (Hyperhidrosis Disease Severity Scale)
Measured: Before treatment and 3±1 weeks after treatment
Health outcome (EQ-5D)
Measured: Before treatment and 3±1 weeks after treatment
LSAS-SR (Liebowitz Social Anxiety Scale-Self Report)
Measured: Before treatment and 3±1 weeks after treatment
MADRS-S (Montgomery-Asberg Depression Rating Scale-Self report)
Measured: 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.
Measured: 3±1 weeks after treatment
DLQI (Dermatology Life Quality Index)
Measured: Before treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionOct 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperhidrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 588 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carl Swartling
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Carl Swartling, Hidrosis Clinic, Stockholm, Sweden
- Investigators
- Carl Swartling, MD, PhD, Principal investigator, Hidrosis Clinic, Warfvinges väg 35, Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930604
- Sponsor's protocol ID
- BTXHH11
- Status last verified
- Mar 2018
- First submitted
- 16 Aug 2013
- Last updated
- 5 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinum Toxin Treatment in Craniofacial, Inguinal, Palmar, Plantar and Truncal Hyperhidrosis, a Randomized, Double Blind, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT01930604
- Acronym / sponsor ID
- BTXHH11
- Conditions
- Hyperhidrosis
- Keywords
- Palmar hyperhidrosis., Plantar hyperhidrosis., Inguinal (groins and buttocks) hyperhidrosis., Craniofacial hyperhidrosis., Truncal hyperhidrosis.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 588 participants (estimated)
- Lead sponsor
- Carl SwartlingUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 29 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Palmar hyperhidrosis, Botox (onabotulinumtoxinA) | Active comparator | Drug: Botox (onabotulinumtoxinA)Solution for injection, individual dosing, maximum dose 400 units, single treatment session. |
| Palmar hyperhidrosis, NaCl | Placebo comparator | Drug: NaCl (placebo)Solution for injection, individual dosing, injection volume corresponding to active comparator, single treatment session. |
| Plantar hyperhidrosis, Botox (onabotulinumtoxinA) | Active comparator | Drug: Botox (onabotulinumtoxinA)Solution for injection, individual dosing, maximum dose 400 units, single treatment session. |
| Plantar hyperhidrosis, NaCl | Placebo comparator | Drug: NaCl (placebo)Solution for injection, individual dosing, injection volume corresponding to active comparator, single treatment session. |
| Inguinal (groins/buttocks) hyperhidrosis, Botox (ona...) | Active comparator | Drug: Botox (onabotulinumtoxinA)Solution for injection, individual dosing, maximum dose 400 units, single treatment session. |
| Inguinal (groins/buttocks) hyperhidrosis, NaCl | Placebo comparator | Drug: NaCl (placebo)Solution for injection, individual dosing, injection volume corresponding to active comparator, single treatment session. |
| Craniofacial hyperhidrosis, NeuroBloc/Myobloc (rima...) | Active comparator | Drug: NeuroBloc/Myobloc (rimabotulinumtoxinB)Solution for injection, individual dosing, maximum dose 2500 units, single treatment session. |
| Craniofacial hyperhidrosis, NaCl | Placebo comparator | Drug: NaCl (placebo)Solution for injection, individual dosing, injection volume corresponding to active comparator, single treatment session. |
| Truncal hyperhidrosis, NeuroBloc/Myobloc (rimabotulinumtoxinB) | Active comparator | Drug: NeuroBloc/Myobloc (rimabotulinumtoxinB)Solution for injection, individual dosing, maximum dose 5000 units, single treatment session. |
| Truncal hyperhidrosis, NaCl | Placebo comparator | Drug: NaCl (placebo)Solution for injection, individual dosing, injection volume corresponding to active comparator, single treatment session. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botox (onabotulinumtoxinA) | Drug | Inguinal (groins/buttocks) hyperhidrosis, Botox (ona...), Palmar hyperhidrosis, Botox (onabotulinumtoxinA), Plantar hyperhidrosis, Botox (onabotulinumtoxinA) |
| NeuroBloc/Myobloc (rimabotulinumtoxinB) | Drug | Craniofacial hyperhidrosis, NeuroBloc/Myobloc (rima...), Truncal hyperhidrosis, NeuroBloc/Myobloc (rimabotulinumtoxinB) |
| NaCl (placebo) | Drug | Craniofacial hyperhidrosis, NaCl, Inguinal (groins/buttocks) hyperhidrosis, NaCl, Palmar hyperhidrosis, NaCl, Plantar hyperhidrosis, NaCl, Truncal hyperhidrosis, NaCl |
Primary outcome
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.
8 secondary outcomes
AE (Adverse Events)
Time frame: Up to 12 weeks
Gravimetry
Time frame: Before treatment and 3±1 weeks after treatment
HDSS (Hyperhidrosis Disease Severity Scale)
Time frame: Before treatment and 3±1 weeks after treatment
Health outcome (EQ-5D)
Time frame: Before treatment and 3±1 weeks after treatment
LSAS-SR (Liebowitz Social Anxiety Scale-Self Report)
Time frame: Before treatment and 3±1 weeks after treatment
MADRS-S (Montgomery-Asberg Depression Rating Scale-Self report)
Time frame: Before treatment and 3±1 weeks after treatment
Global Assessment of Therapy
Time frame: 3±1 weeks after treatment
DLQI (Dermatology Life Quality Index)
Time frame: Before treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl Swartling, MD, PhD principal investigator
Hidrosis Clinic, Warfvinges väg 35, Stockholm, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Botox (onabotulinumtoxinA) and NeuroBloc/Myobloc (rimabotulinumtoxinB) in people with Hyperhidrosis, run by Carl Swartling at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carl Swartling, MD, PhD (0046768534850, carl.swartling@svettmottagningen.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLQI (Dermatology Life Quality Index) (time frame: 3±1 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2018.