HyperhidrosisPhase 2NCT02565732
Safety and Efficacy of Botulinum Toxin Type A Topical Gel for Primary Axillary Hyperhidrosis
A Phase 2 study testing Botulinum toxin type A in people with Hyperhidrosis, run by Revance Therapeutics, Inc. at 1 site in United States.
Trial summary
This is a safety and efficacy study of botulinum toxin type A in subjects with primary axillary hyperhidrosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperhidrosis
- What is being tested?
- Botulinum toxin type A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Jan 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary axillary hyperhidrosis
- Female or male, 18 years of age or older in good general health
- Excessive sweating interferes with daily life activities and scores 3 or 4 on the HDSS at Screening and Baseline
- Axillary sweat production of at least 50 mg/5 min measured gravimetrically
Who cannot join
- Any neurological condition, that may place the subject at increased risk with exposure to botulinum toxin type A such as amyotrophic lateral sclerosis and motor neuropathy, Lambert-Eaton syndrome, and Myasthenia gravis
- Muscle weakness or paralysis, particularly in the upper extremities
- Active skin disease or irritation or disrupted barrier at the treatment area
- Undergone any procedures which may affect the axillary areas
- Treatment with botulinum toxin type A in the axilla in the last 9 months or anywhere in the body in the last 6 months
- Any prior axillary use of an anti-hyperhidrosis medical device
- If menopausal had symptoms of menopause such as sweating or flushing within the last year
Trial locations and contacts
1 site in 1 country.
About this study
This is a safety and efficacy study of botulinum toxin type A in subjects with primary axillary hyperhidrosis.
- Conditions
- Hyperhidrosis
- Being tested
- Botulinum toxin type A, Placebo comparator
- Medical subject headings
- Hyperhidrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type ABiological
Botulinum toxin type A, Dose A, Topical
Botulinum toxin type ABiological
Botulinum toxin type A, Dose B, Topical
Placebo comparatorBiological
Placebo, Dose C, Topical
| Study group | Role | What they receive |
|---|---|---|
| Dose A | Experimental | Botulinum toxin type A Receives: Biological: Botulinum toxin type A |
| Dose B | Experimental | Botulinum toxin type A Receives: Biological: Botulinum toxin type A |
| Dose C | Placebo comparator | Placebo comparator Receives: Biological: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyperhidrosis Disease Severity Scale (HDSS)
Improvement at follow-up in the experimental groups compared to the placebo group
Measured: Week 4
Gravimetry
The amount of sweat measured gravimetrically
Measured: Week 4
Secondary outcomes (1)
Dermatology Life Quality Index (DLQI)
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2015
- Study completionJan 2016
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revance Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565732
- Sponsor's protocol ID
- RT001-CL045
- Status last verified
- Mar 2016
- First submitted
- 29 Sep 2015
- Last updated
- 4 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Botulinum Toxin Type A Topical Gel for Primary Axillary Hyperhidrosis
- ClinicalTrials.gov ID
- NCT02565732
- Acronym / sponsor ID
- RT001-CL045
- Conditions
- Hyperhidrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Revance Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 1 Oct 2015 (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.
This is a safety and efficacy study of botulinum toxin type A in subjects with primary axillary hyperhidrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose A | Experimental | Biological: Botulinum toxin type ABotulinum toxin type A |
| Dose B | Experimental | Biological: Botulinum toxin type ABotulinum toxin type A |
| Dose C | Placebo comparator | Biological: Placebo comparatorPlacebo comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary axillary hyperhidrosis
- Female or male, 18 years of age or older in good general health
- Excessive sweating interferes with daily life activities and scores 3 or 4 on the HDSS at Screening and Baseline
- Axillary sweat production of at least 50 mg/5 min measured gravimetrically
Key exclusion criteria (7 listed)
- Any neurological condition, that may place the subject at increased risk with exposure to botulinum toxin type A such as amyotrophic lateral sclerosis and motor neuropathy, Lambert-Eaton syndrome, and Myasthenia gravis
- Muscle weakness or paralysis, particularly in the upper extremities
- Active skin disease or irritation or disrupted barrier at the treatment area
- Undergone any procedures which may affect the axillary areas
- Treatment with botulinum toxin type A in the axilla in the last 9 months or anywhere in the body in the last 6 months
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 |
|---|---|---|
| Botulinum toxin type ABotulinum toxin type A, Dose A, Topical | Biological | Dose A |
| Botulinum toxin type ABotulinum toxin type A, Dose B, Topical | Biological | Dose B |
| Placebo comparatorPlacebo, Dose C, Topical | Biological | Dose C |
Primary outcome
Hyperhidrosis Disease Severity Scale (HDSS)
Time frame: Week 4
Improvement at follow-up in the experimental groups compared to the placebo group
Gravimetry
Time frame: Week 4
The amount of sweat measured gravimetrically
1 secondary outcome
Dermatology Life Quality Index (DLQI)
Time frame: Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Botulinum toxin type A in people with Hyperhidrosis, run by Revance Therapeutics, Inc. at 1 site in United States.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 4 Aug 2016. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hyperhidrosis Disease Severity Scale (HDSS) (time frame: Week 4). The study lists 2 primary outcomes in all. 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 4 Aug 2016.