HyperhidrosisPhase 2NCT02193139
Safety and Efficacy of an Anticholinergic Agent for Treatment of Primary Axillary Hyperhidrosis
A Phase 2 study testing WL8713, 6 mg, WL8713, 12 mg and WL8713, 18 mg in people with Hyperhidrosis, run by Watson Pharmaceuticals at 1 site in United States.
Trial summary
This Phase 2 study is designed to evaluate multiple doses of an anticholinergic-containing medication and identify the dose or doses that may effectively reduce axillary sweating in hyperhidrotic subjects. The anticholinergic agent being studied is designated WL8713. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Hyperhidrosis
- What is being tested?
- WL8713, 6 mg, WL8713, 12 mg and WL8713, 18 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 195 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Jun 2014
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy volunteers with primary axillary hyperhidrosis
- Poor quality of life rating on the Hyperhidrosis Disease Severity Scale (score of 3 or 4)
- Has a baseline gravimetric measurement of spontaneous resting sweat production of ≥100 mg/10 min at room at room temperature in at least one axilla
- Meets at least two of the following criteria (self-reported):
- sweating is bilateral and symmetrical
- excessive sweating impairs daily activities
Show all 10Show fewer
- subject experiences at least one sweating episode per week
- excessive sweating onset was earlier than age 25 years
- has a positive family history for excessive sweating
- cessation of sweating during sleep
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of An Anticholinergic Agent for the Treatment of Primary Axillary Hyperhidrosis
This Phase 2 study is designed to evaluate multiple doses of an anticholinergic-containing medication and identify the dose or doses that may effectively reduce axillary sweating in hyperhidrotic subjects. The anticholinergic agent being studied is designated WL8713.
- Conditions
- Hyperhidrosis
- Being tested
- WL8713, 6 mg, WL8713, 12 mg, WL8713, 18 mg, WL8713, 24 mg, Placebo
- Medical subject headings
- Hyperhidrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WL8713, 6 mgDrug
WL8713, 12 mgDrug
WL8713, 18 mgDrug
WL8713, 24 mgDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| WL8713, 6 mg | Experimental | 6 mg WL8713 administered daily Receives: Drug: WL8713, 6 mg |
| WL8713, 12 mg | Experimental | 12 mg WL8713 administered daily Receives: Drug: WL8713, 12 mg |
| WL8713, 18 mg | Experimental | 18 mg WL8713 administered daily Receives: Drug: WL8713, 18 mg |
| WL8713, 24 mg | Experimental | 24 mg WL8713 administered daily Receives: Drug: WL8713, 24 mg |
| Placebo | Placebo comparator | placebo administered daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gravimetric measurement of sweat production
Change from baseline in mean (bilateral average) sweat weight at Week 6 (LOCF)
Measured: 6 weeks
Secondary outcomes (3)
Hyperhidrosis Disease Severity Scale (HDSS) scores
Percentage of subjects with a change from baseline in HDSS scores of at least -2 points at Week 6 (LOCF)
Measured: 6 weeks
Dermatology Life Quality Index (DLQI) scores
Change from baseline in DLQI total score at Week 6 (LOCF)
Measured: 6 weeks
Global Assessment of Disease State responses
Global Assessment of Disease State score at Week 6 (LOCF)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study startDec 2013
- Primary completionJun 2014
- Study completionJun 2014
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
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Watson Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02193139
- Sponsor's protocol ID
- OH1304
- Status last verified
- Nov 2014
- First submitted
- 29 Jun 2014
- Last updated
- 6 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of An Anticholinergic Agent for the Treatment of Primary Axillary Hyperhidrosis
- ClinicalTrials.gov ID
- NCT02193139
- Acronym / sponsor ID
- OH1304
- Conditions
- Hyperhidrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Watson PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 17 Jul 2014 (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 Phase 2 study is designed to evaluate multiple doses of an anticholinergic-containing medication and identify the dose or doses that may effectively reduce axillary sweating in hyperhidrotic subjects. The anticholinergic agent being studied is designated WL8713.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| WL8713, 6 mg | Experimental | Drug: WL8713, 6 mg6 mg WL8713 administered daily |
| WL8713, 12 mg | Experimental | Drug: WL8713, 12 mg12 mg WL8713 administered daily |
| WL8713, 18 mg | Experimental | Drug: WL8713, 18 mg18 mg WL8713 administered daily |
| WL8713, 24 mg | Experimental | Drug: WL8713, 24 mg24 mg WL8713 administered daily |
| Placebo | Placebo comparator | Drug: Placeboplacebo administered daily |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy volunteers with primary axillary hyperhidrosis
- Poor quality of life rating on the Hyperhidrosis Disease Severity Scale (score of 3 or 4)
- Has a baseline gravimetric measurement of spontaneous resting sweat production of ≥100 mg/10 min at room at room temperature in at least one axilla
- Meets at least two of the following criteria (self-reported):
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| WL8713, 6 mg | Drug | WL8713, 6 mg |
| WL8713, 12 mg | Drug | WL8713, 12 mg |
| WL8713, 18 mg | Drug | WL8713, 18 mg |
| WL8713, 24 mg | Drug | WL8713, 24 mg |
| Placebo | Drug | Placebo |
Primary outcome
Gravimetric measurement of sweat production
Time frame: 6 weeks
Change from baseline in mean (bilateral average) sweat weight at Week 6 (LOCF)
3 secondary outcomes
Hyperhidrosis Disease Severity Scale (HDSS) scores
Time frame: 6 weeks
Dermatology Life Quality Index (DLQI) scores
Time frame: 6 weeks
Global Assessment of Disease State responses
Time frame: 6 weeks
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 6 Aug 2015.
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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 WL8713, 6 mg, WL8713, 12 mg and WL8713, 18 mg in people with Hyperhidrosis, run by Watson Pharmaceuticals 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 10 inclusion and 0 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 6 Aug 2015. 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?
Gravimetric measurement of sweat production (time frame: 6 weeks). 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 6 Aug 2015.