HyperhidrosisPhase 2NCT02479139
Clinical Trial To Evaluate ANT-1207 In Participants With Primary Axillary Hyperhidrosis
A Phase 2 study testing ANT-1207 in people with Hyperhidrosis, run by Allergan at 19 sites in United States.
Trial summary
The purpose of this study is to establish the therapeutic range of ANT-1207 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
- Hyperhidrosis
- What is being tested?
- ANT-1207
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- 19 sitesUnited States
- Study dates
- 3 Jun 2015to 29 Feb 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 primary axillary hyperhidrosis
- HDSS score of ≥3
- threshold sweat production/axilla in 5 minutes as measured gravimetrically
- willingness to shave underarms prior to each study visit
Who cannot join
- botulinum toxin treatment in the prior 6 months
- signs of infection in the axilla
- skin affliction in the axilla requiring medical treatment
- oral anticholinergic treatment
- use of antiperspirants, deodorants, powders, or lotions
- use of axillary depilatories or axillary epilation
- history of surgery or other interventions for axillary hyperhidrosis
- female subjects who are pregnant or are nursing a child
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Westlake Dermatology Clinical Research Center
Austin, Texas, 78746
Shideler Clinical Research Center
Carmel, Indiana, 46032
PMG Research of Cary
Cary, North Carolina, 27518
Dermatology and Laser Center of Charleston, PA
Charleston, South Carolina, 29414
J&S Studies, Inc.
College Station, Texas, 77845
San Marcus Research Clinic, Inc.
Hialeah, Florida, 33015
Allus Clinical Research
Jenkintown, Pennsylvania, 19046
The Skin Wellness Center
Knoxville, Tennessee, 37922
William Coleman III, MD, APMC
Metairie, Louisiana, 70006
Baumann Cosmetic & Research Institute
Miami, Florida, 33137
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Lupo Center for Aesthetic & General Dermatology
New Orleans, Louisiana, 70124
JUVA Skin and Laser Center
New York, New York, 10021
Virginia Clinical Research Inc.
Norfolk, Virginia, 23507
Skin Specialists, PC
Omaha, Nebraska, 68144
Radiant Research, Inc.
Pinellas Park, Florida, 33781
Skin Search of Rochester, Inc.
Rochester, New York, 14623
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
Research Institute of the Southeast, LLC
West Palm Beach, Florida, 33401
About this study
Official title: Clinical Trial to Evaluate ANT-1207 in the Treatment of Primary Axillary Hyperhidrosis in Adults
The purpose of this study is to establish the therapeutic range of ANT-1207 in the treatment of primary axillary hyperhidrosis.
- Conditions
- Hyperhidrosis
- Being tested
- Vehicle, ANT-1207
- Medical subject headings
- Hyperhidrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VehicleBiological
Vehicle for ANT-1207 liniment formulation without active ingredient.
ANT-1207Biological
Botulinum toxin Type A topical liniment (ANT-1207).
| Study group | Role | What they receive |
|---|---|---|
| Vehicle | Placebo comparator | Vehicle for botulinum toxin Type A topical liniment (ANT-1207) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. Receives: Biological: Vehicle |
| ANT-1207 Dose 1 | Experimental | Botulinum toxin Type A topical liniment (ANT-1207) Dose 1 (lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. Receives: Biological: ANT-1207 |
| ANT-1207 Dose 2 | Experimental | Botulinum toxin Type A topical liniment (ANT-1207) Dose 2 (second lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. Receives: Biological: ANT-1207 |
| ANT-1207 Dose 3 | Experimental | Botulinum toxin Type A topical liniment (ANT-1207) Dose 3 (mid-level dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. Receives: Biological: ANT-1207 |
| ANT-1207 Dose 4 | Experimental | Botulinum toxin Type A topical liniment (ANT-1207) Dose 4 (second highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. Receives: Biological: ANT-1207 |
| ANT-1207 Dose 5 | Experimental | Botulinum toxin Type A topical liniment (ANT-1207) Dose 5 (highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. Receives: Biological: ANT-1207 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Both a Change From Baseline in Hyperhidrosis Disease Severity Scale (HDSS) Score by ≥ 2 Points and a Change From Baseline in Gravimetric Sweat Production (GSP) by ≥ 50%
The HDSS is a patient completed scale that measures how excessive sweating effects quality of life using a 4-point scale where: 1=My underarm sweating is not noticeable and never interferes with my daily activities to 4= My underarm sweating is intolerable and always interferes with my daily activities.
GSP was measured using a pre-weighed filter paper placed into the axilla area (armpit) to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced.
The HDSS and the GSP were assessed at Baseline and Week 12. The change from Baseline was calculated. The percentage of participants who had both a change (reduction) from Baseline in HDSS score by ≥ 2 points and a change (reduction) from Baseline in GSP by ≥ 50% is reported.
Measured: Baseline, Week 12
Secondary outcomes (2)
Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points
The HDSS is a patient completed scale that measures how excessive sweating effects quality of life using a 4-point scale where: 1=My underarm sweating is not noticeable and never interferes with my daily activities to 4= My underarm sweating is intolerable and always interferes with my daily activities.
The change from Baseline was calculated. The percentage of participants who had a change (reduction) from Baseline in HDSS score by ≥ 2 points is reported.
Measured: Baseline, Weeks 4, 8, 12 and 18
Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50%
GSP was measured using a pre-weighed filter paper placed into the axilla area (armpit) to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced.
The change from Baseline was calculated. The percentage of participants who had a change (reduction) from Baseline in GSP by ≥ 50% is reported.
Measured: Baseline, Weeks 4, 8, 12 and 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study start3 Jun 2015
- Primary completion29 Feb 2016
- Study completion29 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joan-En Lin, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479139
- Sponsor's protocol ID
- ANT-1207-HHID-205
- Status last verified
- Aug 2017
- First submitted
- 19 Jun 2015
- Last updated
- 20 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate ANT-1207 in the Treatment of Primary Axillary Hyperhidrosis in Adults
- ClinicalTrials.gov ID
- NCT02479139
- Acronym / sponsor ID
- ANT-1207-HHID-205
- Conditions
- Hyperhidrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2015 (actual)
- Primary completion
- 29 Feb 2016 (actual)
- Study completion
- 29 Feb 2016 (actual)
- First posted
- 24 Jun 2015 (estimated)
- Results
- Posted 20 Sep 2017
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 establish the therapeutic range of ANT-1207 in the treatment of primary axillary hyperhidrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Vehicle | Placebo comparator | Biological: VehicleVehicle for botulinum toxin Type A topical liniment (ANT-1207) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. |
| ANT-1207 Dose 1 | Experimental | Biological: ANT-1207Botulinum toxin Type A topical liniment (ANT-1207) Dose 1 (lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. |
| ANT-1207 Dose 2 | Experimental | Biological: ANT-1207Botulinum toxin Type A topical liniment (ANT-1207) Dose 2 (second lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. |
| ANT-1207 Dose 3 | Experimental | Biological: ANT-1207Botulinum toxin Type A topical liniment (ANT-1207) Dose 3 (mid-level dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. |
| ANT-1207 Dose 4 | Experimental | Biological: ANT-1207Botulinum toxin Type A topical liniment (ANT-1207) Dose 4 (second highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. |
| ANT-1207 Dose 5 | Experimental | Biological: ANT-1207Botulinum toxin Type A topical liniment (ANT-1207) Dose 5 (highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ages 18 - 70 years of age
- diagnosis of primary axillary hyperhidrosis
- HDSS score of ≥3
- threshold sweat production/axilla in 5 minutes as measured gravimetrically
- willingness to shave underarms prior to each study visit
Key exclusion criteria (8 listed)
- botulinum toxin treatment in the prior 6 months
- signs of infection in the axilla
- skin affliction in the axilla requiring medical treatment
- oral anticholinergic treatment
- use of antiperspirants, deodorants, powders, or lotions
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 |
|---|---|---|
| VehicleVehicle for ANT-1207 liniment formulation without active ingredient. | Biological | Vehicle |
| ANT-1207Botulinum toxin Type A topical liniment (ANT-1207). | Biological | ANT-1207 Dose 1, ANT-1207 Dose 2, ANT-1207 Dose 3, ANT-1207 Dose 4, ANT-1207 Dose 5 |
Primary outcome
Percentage of Participants With Both a Change From Baseline in Hyperhidrosis Disease Severity Scale (HDSS) Score by ≥ 2 Points and a Change From Baseline in Gravimetric Sweat Production (GSP) by ≥ 50%
Time frame: Baseline, Week 12
The HDSS is a patient completed scale that measures how excessive sweating effects quality of life using a 4-point scale where: 1=My underarm sweating is not noticeable and never interferes with my daily activities to 4= My underarm sweating is intolerable and always interferes with my daily activities. GSP was measured using a pre-weighed filter paper placed into the axilla area (armpit) to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. The HDSS and the GSP were assessed at Baseline and Week 12. The change from Baseline was calculated. The percentage of participants who had both a change (reduction) from Baseline in HDSS score by ≥ 2 points and a change (reduction) from Baseline in GSP by ≥ 50% is reported.
2 secondary outcomes
Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points
Time frame: Baseline, Weeks 4, 8, 12 and 18
Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50%
Time frame: Baseline, Weeks 4, 8, 12 and 18
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Joan-En Lin study director
Allergan
19 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-1207 in people with Hyperhidrosis, run by Allergan at 19 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 5 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 20 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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?
Yes. Results are posted in the registry (first posted 20 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Both a Change From Baseline in Hyperhidrosis Disease Severity Scale (HDSS) Score by ≥ 2 Points and a Change From Baseline in Gravimetric Sweat Production (GSP) by ≥ 50% (time frame: Baseline, Week 12). 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 20 Sep 2017.