HyperhidrosisPhase 2NCT02336503
A Safety and Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis
A Phase 2 study testing BBI-4000 Gel, 5%, BBI-4000 Gel, 10% and BBI-4000 Gel, 15% in people with Hyperhidrosis, run by Botanix Pharmaceuticals at 12 sites in United States.
Trial summary
To assess the safety and efficacy of 3 doses of BBI-4000 and vehicle (4 treatment arms), when applied once a day for 4 weeks, for the treatment of axillary hyperhidrosis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hyperhidrosis
- What is being tested?
- BBI-4000 Gel, 5%, BBI-4000 Gel, 10% and BBI-4000 Gel, 15%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 189 participants
- Where
- 12 sitesUnited States
- Study dates
- 10 Mar 2015to 5 Nov 2015
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary axillary hyperhidrosis of at least 6 months's duration
- Hyperhidrosis disease severity score of 3 or 4 at baseline
- Gravimetric test at baseline indicating at least 50 mg of sweat production at rest in each axilla, in 5 minutes (room temperature)
- Willing to refrain from using any other antiperspirant agent for the duration of the study.
- Females of childbearing potential must agree to use a medically acceptable method of contraception while participating in the study.
Who cannot join
- Any skin or subcutaneous tissue conditions in the axilla or near the axillary area, other than hyperhidrosis.
- Prior use of any prohibited medication(s) or procedure(s) within the specified timeframe, including:
- Botulinum toxin to the axillary area within 1 year of the baseline visit.
- Axillary iontophoresis within 12 weeks of baseline visit.
- Axillary thermolysis, sympathectomy or surgical procedures of the axillary area at any time in the past.
- Use of systemic and/or topical anticholinergic treatment within 30 days of the baseline visit.
Show all 14Show fewer
- Subjects with hyperhidrosis symptoms initiated or exacerbated with their menopause.
- Subjects with history of diabetes mellitus, renal impairment, hepatic impairment, thyroid disease, malignancy, glaucoma, intestinal obstructive or motility disease, obstructive uropathy, myasthenia gravis, benign prostatic hyperplasia (BPH), neurological conditions, psychiatric conditions, Sjögren's syndrome, Sicca syndrome, or cardiac abnormalities that may alter normal sweat production or may be exacerbated by the use of anticholinergics.
- Subjects with known hypersensitivity to glycopyrrolate, anticholinergics, or any of the components of the topical formulation.
- Pregnant or lactating women.
- Use of an investigational drug within 30 days prior to the baseline visit.
- Prior treatment with the study drug in a previous trial.
- Any major illness within 30 days before the screening examination.
- Any other condition or laboratory abnormality that, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study or may interfere with the assessments included in the study.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
Center for Clinical and Cosmetic Research
Aventura, Florida, 33180
Shideler Clinical Research Center
Carmel, Indiana, 46032
Center for Dermatology Clinical Research, Inc.
Fremont, California, 94538
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
The Center for Skin Research
Houston, Texas, 77056
International Dermatology Research, Inc.
Miami, Florida, 33144
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168
Therapeutics Clinical Research
San Diego, California, 92123
International Clinical Research
Sanford, Florida, 32771
Saint Louis University Dermatology
St Louis, Missouri, 63122
About this study
Official title: A Multicenter, Randomized, Double Blind, Vehicle-Controlled Study to Evaluate the Safety and Effect on Sweat Production of 3 Concentrations of Topically Applied BBI-4000 in Subjects With Axillary Hyperhidrosis
To assess the safety and efficacy of 3 doses of BBI-4000 and vehicle (4 treatment arms), when applied once a day for 4 weeks, for the treatment of axillary hyperhidrosis.
Read the detailed description
This is a Multicenter, Randomized, Double Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of 3 concentrations of Topically Applied BBI-4000 in Subjects with Axillary Hyperhidrosis.
Participating subjects will apply BBI-4000 once a day for 4 weeks in their axillae. The 4 week treatment period will be followed by a 2 week follow-up period.
Safety will be assessed through collection of vital signs, adverse events, local skin responses, hematology and serum chemistry laboratory testing and ECGs.
Efficacy will be assessed using the Hyperhidrosis Disease Severity Scale (patient reported outcome) and through gravimetrically measured sweat production.
PK blood samples will be taken from study subjects from selected centers.
- Conditions
- Hyperhidrosis
- Being tested
- BBI-4000 Gel, 5%, BBI-4000 Gel, 10%, BBI-4000 Gel, 15%, Vehicle
- Medical subject headings
- Hyperhidrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBI-4000 Gel, 5%Drug
Also called BBI-4000 Low Dose
BBI-4000 Gel, 5%
BBI-4000 Gel, 10%Drug
Also called BBI-4000 Middle Dose
BBI-4000 Gel, 10%
BBI-4000 Gel, 15%Drug
Also called BBI-4000 High Dose
BBI-4000 Gel, 15%
VehicleDrug
Also called Placebo
Placebo, BBI-4000 Gel, 0%
| Study group | Role | What they receive |
|---|---|---|
| BBI-4000 Gel, 5% | Experimental | Low concentration of BBI-4000; BBI-4000 Gel, 5% Receives: Drug: BBI-4000 Gel, 5% |
| BBI-4000 Gel, 10% | Experimental | Middle concentration of BBI-4000; BBI-4000 Gel, 10% Receives: Drug: BBI-4000 Gel, 10% |
| BBI-4000 Gel, 15% | Experimental | High concentration of BBI-4000; BBI-4000 Gel, 15% Receives: Drug: BBI-4000 Gel, 15% |
| Vehicle | Placebo comparator | Vehicle (placebo); BBI-4000 Gel, 0% Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects Achieving at Least 2-point Decrease in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Week 4
Severity is scored with increasing scale, scores 1-4 where minimal severity is scored: 1=My sweating is never noticeable and never interferes with my daily activities and most severe score is: 4=My sweating is intolerable and always interferes with my daily activities
Measured: Baseline through Week 4 (Day 29)
Secondary outcomes (3)
Proportion of Subjects Achieving at Least 1-point Improvement in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Week 4
Severity is scored with increasing scale, scores 1-4 where minimal severity is scored: 1=My sweating is never noticeable and never interferes with my daily activities and most severe score is: 4=My sweating is intolerable and always interferes with my daily activities
Measured: Baseline through Week 4 (Day 29)
Absolute Change in Gravimetrically Measured Sweat Production From Baseline to Week 4 (Day 29)
Sweat production unit of measure was weight-based (mg); absolute change was calculated by adding the left and right axillae sweat weights and calculating absolute change by subtracting day 29 from baseline sweat weights
Measured: Baseline through Week 4 (Day 29)
Percent Change in Gravimetrically Measured Sweat Production From Baseline to Week 4
Randomized participants that provided samples for gravimetric sweat measures, baseline and day 29; Percent Change was calculated by dividing absolute change by baseline gravimetric measurement x 100%
Measured: Baseline through Week 4 (Day 29)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study start10 Mar 2015
- Primary completion5 Nov 2015
- Study completion5 Nov 2015
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
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Botanix Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patricia Walker, MD PhD, Study director, Botanix Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336503
- Sponsor's protocol ID
- BBI-4000-CL-201
- Status last verified
- Dec 2022
- First submitted
- 8 Jan 2015
- Last updated
- 15 Mar 2023
- 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 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double Blind, Vehicle-Controlled Study to Evaluate the Safety and Effect on Sweat Production of 3 Concentrations of Topically Applied BBI-4000 in Subjects With Axillary Hyperhidrosis
- ClinicalTrials.gov ID
- NCT02336503
- Acronym / sponsor ID
- BBI-4000-CL-201
- Conditions
- Hyperhidrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Botanix PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2015 (actual)
- Primary completion
- 5 Nov 2015 (actual)
- Study completion
- 5 Nov 2015 (actual)
- First posted
- 13 Jan 2015 (estimated)
- Results
- Posted 15 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the safety and efficacy of 3 doses of BBI-4000 and vehicle (4 treatment arms), when applied once a day for 4 weeks, for the treatment of axillary hyperhidrosis.
Detailed description
This is a Multicenter, Randomized, Double Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of 3 concentrations of Topically Applied BBI-4000 in Subjects with Axillary Hyperhidrosis.
Participating subjects will apply BBI-4000 once a day for 4 weeks in their axillae. The 4 week treatment period will be followed by a 2 week follow-up period.
Safety will be assessed through collection of vital signs, adverse events, local skin responses, hematology and serum chemistry laboratory testing and ECGs.
Efficacy will be assessed using the Hyperhidrosis Disease Severity Scale (patient reported outcome) and through gravimetrically measured sweat production.
PK blood samples will be taken from study subjects from selected centers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BBI-4000 Gel, 5% | Experimental | Drug: BBI-4000 Gel, 5%Low concentration of BBI-4000; BBI-4000 Gel, 5% |
| BBI-4000 Gel, 10% | Experimental | Drug: BBI-4000 Gel, 10%Middle concentration of BBI-4000; BBI-4000 Gel, 10% |
| BBI-4000 Gel, 15% | Experimental | Drug: BBI-4000 Gel, 15%High concentration of BBI-4000; BBI-4000 Gel, 15% |
| Vehicle | Placebo comparator | Drug: VehicleVehicle (placebo); BBI-4000 Gel, 0% |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary axillary hyperhidrosis of at least 6 months's duration
- Hyperhidrosis disease severity score of 3 or 4 at baseline
- Gravimetric test at baseline indicating at least 50 mg of sweat production at rest in each axilla, in 5 minutes (room temperature)
- Willing to refrain from using any other antiperspirant agent for the duration of the study.
- Females of childbearing potential must agree to use a medically acceptable method of contraception while participating in the study.
Key exclusion criteria (14 listed)
- Any skin or subcutaneous tissue conditions in the axilla or near the axillary area, other than hyperhidrosis.
- Prior use of any prohibited medication(s) or procedure(s) within the specified timeframe, including:
- Use of systemic and/or topical anticholinergic treatment within 30 days of the baseline visit.
- Subjects with hyperhidrosis symptoms initiated or exacerbated with their menopause.
- Subjects with history of diabetes mellitus, renal impairment, hepatic impairment, thyroid disease, malignancy, glaucoma, intestinal obstructive or motility disease, obstructive uropathy, myasthenia gravis, benign prostatic hyperplasia (BPH), neurological conditions, psychiatric conditions, Sjögren's syndrome, Sicca syndrome, or cardiac abnormalities that may alter normal sweat production or may be exacerbated by the use of anticholinergics.
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 |
|---|---|---|
| BBI-4000 Gel, 5%Also: BBI-4000 Low DoseBBI-4000 Gel, 5% | Drug | BBI-4000 Gel, 5% |
| BBI-4000 Gel, 10%Also: BBI-4000 Middle DoseBBI-4000 Gel, 10% | Drug | BBI-4000 Gel, 10% |
| BBI-4000 Gel, 15%Also: BBI-4000 High DoseBBI-4000 Gel, 15% | Drug | BBI-4000 Gel, 15% |
| VehicleAlso: PlaceboPlacebo, BBI-4000 Gel, 0% | Drug | Vehicle |
Primary outcome
Proportion of Subjects Achieving at Least 2-point Decrease in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Week 4
Time frame: Baseline through Week 4 (Day 29)
Severity is scored with increasing scale, scores 1-4 where minimal severity is scored: 1=My sweating is never noticeable and never interferes with my daily activities and most severe score is: 4=My sweating is intolerable and always interferes with my daily activities
3 secondary outcomes
Proportion of Subjects Achieving at Least 1-point Improvement in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Week 4
Time frame: Baseline through Week 4 (Day 29)
Absolute Change in Gravimetrically Measured Sweat Production From Baseline to Week 4 (Day 29)
Time frame: Baseline through Week 4 (Day 29)
Percent Change in Gravimetrically Measured Sweat Production From Baseline to Week 4
Time frame: Baseline through Week 4 (Day 29)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- 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.
Patricia Walker, MD PhD study director
Botanix Pharmaceuticals
12 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 BBI-4000 Gel, 5%, BBI-4000 Gel, 10% and BBI-4000 Gel, 15% in people with Hyperhidrosis, run by Botanix Pharmaceuticals at 12 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 14 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 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 15 Mar 2023). 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?
Proportion of Subjects Achieving at Least 2-point Decrease in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Week 4 (time frame: Baseline through Week 4 (Day 29)). 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 15 Mar 2023.