Primary Axillary HyperhidrosisPhase 2NCT01799824
Clinical Trial to Evaluate ANT-1403 in the Treatment of Primary Axillary Hyperhidrosis
A Phase 2 study testing ANT-1403 in people with Primary Axillary Hyperhidrosis, run by Anterios Inc. at 9 sites in United States.
Trial summary
The purpose of this study is to confirm the effect of ANT-1403 in the treatment of primary axillary hyperhidrosis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Primary Axillary Hyperhidrosis
- What is being tested?
- ANT-1403
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 9 sitesUnited States
- Study dates
- Feb 2013to Jul 2013
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ages 18 - 70 years of age
- diagnosis of moderate to severe primary axillary hyperhidrosis
- ≥50 mg of sweat production/axilla in 5 minutes as measured gravimetrically
- HDSS score of ≥3
Who cannot join
- diagnosis of secondary hyperhidrosis
- skin affliction in the axilla requiring medical treatment
- 20% aluminum hydrochloride, e.g. Drysol®, in 2 weeks prior of Baseline
- oral anticholinergic treatment
- botulinum toxin treatment in the prior 9 months
- history of surgery for axillary hyperhidrosis
- present or history of neuromuscular disease
- female subjects who are pregnant or are nursing a child
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Study site
East Windsor, New Jersey, 08520
Study site
Louisville, Kentucky, 40202
Study site
Miami, Florida, 33137
Study site
Norfolk, Virginia, 23507
Study site
Pinellas Park, Florida, 33781
Study site
Raleigh, North Carolina, 27612
Study site
Rochester, New York, 14623
Study site
West Palm Beach, Florida, 33401
Study site
Yardley, Pennsylvania, 19067
About this study
Official title: Clinical Trial to Evaluate ANT-1403 in the Treatment of Primary Axillary Hyperhidrosis in Adults
The purpose of this study is to confirm the effect of ANT-1403 in the treatment of primary axillary hyperhidrosis.
- Conditions
- Primary Axillary Hyperhidrosis
- Being tested
- ANT-1403, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANT-1403Biological
placeboBiological
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | ANT-1403 Receives: Biological: ANT-1403 |
| Vehicle | Placebo comparator | Vehicle Receives: Biological: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
HDSS
Measured: Week 8
Secondary outcomes (1)
GSP
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Axillary 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anterios Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799824
- Sponsor's protocol ID
- ANT-1403-HHID-202
- Status last verified
- Nov 2013
- First submitted
- 25 Feb 2013
- Last updated
- 10 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate ANT-1403 in the Treatment of Primary Axillary Hyperhidrosis in Adults
- ClinicalTrials.gov ID
- NCT01799824
- Acronym / sponsor ID
- ANT-1403-HHID-202
- Conditions
- Primary Axillary Hyperhidrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Anterios Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 27 Feb 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.
The purpose of this study is to confirm the effect of ANT-1403 in the treatment of primary axillary hyperhidrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Biological: ANT-1403ANT-1403 |
| Vehicle | Placebo comparator | Biological: placeboVehicle |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ages 18 - 70 years of age
- diagnosis of moderate to severe primary axillary hyperhidrosis
- ≥50 mg of sweat production/axilla in 5 minutes as measured gravimetrically
- HDSS score of ≥3
Key exclusion criteria (8 listed)
- diagnosis of secondary hyperhidrosis
- skin affliction in the axilla requiring medical treatment
- 20% aluminum hydrochloride, e.g. Drysol®, in 2 weeks prior of Baseline
- oral anticholinergic treatment
- botulinum toxin treatment in the prior 9 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 |
|---|---|---|
| ANT-1403 | Biological | Active |
| placebo | Biological | Vehicle |
Primary outcome
HDSS
Time frame: Week 8
1 secondary outcome
GSP
Time frame: Week 8
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 10 Dec 2013.
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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ANT-1403 in people with Primary Axillary Hyperhidrosis, run by Anterios Inc. at 9 sites 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 8 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 10 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
HDSS (time frame: Week 8). 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 10 Dec 2013.