HyperhidrosisPhase 1NCT02058264
A Safety, Tolerability and Preliminary Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis
A Phase 1 study testing BBI-4000 in people with Hyperhidrosis, run by Botanix Pharmaceuticals.
Trial summary
The purpose of this study is to determine the safety, tolerability, pharmacokinetics and treatment effect of BBI-4000 when topically applied to subjects with axillary hyperhidrosis. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Hyperhidrosis
- What is being tested?
- BBI-4000
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Sep 2014
- Phase
- Phase 1
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or Female subjects from 18 to 45 years of age in good general health.
- Primary axillary hyperhidrosis of at least 6 months duration.
- Hyperhidrosis Disease Severity Score (HDSS) of 3 or 4 at baseline.
- Gravimetric test at baseline indicating at least 100mg of axillary sweat production in a 5 min period.
- Use of a medically appropriate contraceptive method.
Who cannot join
- Prior axillary use of botulinum toxin within 2 years of study entry.
- Prior iontophoresis treatment for axillary hyperhidrosis within 12 weeks of study entry.
- Prior surgical procedures for hyperhidrosis or surgical procedures in the axillary areas for any reason.
- Use of anticholinergic treatment, beta-blocker, alpha-adrenergic or other prescription treatment for hyperhidrosis.
- History of diabetes mellitus, thyroid disease, malignancy, glaucoma, intestinal obstructive or motility disease, obstructive uropathy, myasthenia gravis, prostate hypertrophy, neurological conditions or cardiac abnormalities.
- Known condition that may cause hyperhidrosis.
- Use of an investigational drug within 30 days prior to entry into this study.
About this study
Official title: A Randomized, Double Blinded, Vehicle-Controlled Study to Evaluate the Safety and the Effect on Sweat Production of Topically Applied BBI-4000 in Subjects With Hyperhidrosis.
The purpose of this study is to determine the safety, tolerability, pharmacokinetics and treatment effect of BBI-4000 when topically applied to subjects with axillary hyperhidrosis.
Read the detailed description
This is a randomized, vehicle controlled, double blind study in subjects with axillary hyperhidrosis designed to assess the safety, tolerability and the effect on sweat production of topically applied BBI-4000 for 14 days.
Safety will be assessed though vital signs, physical exam, adverse events, local skin reactions and laboratory tests (blood chemistry and hematology).
Efficacy will be assessed though the gravimetrically measured sweat production and the Hyperhidrosis Disease Severity Score (HDSS).
Pharmacokinetic information will also be collected.
- Conditions
- Hyperhidrosis
- Being tested
- BBI-4000
- Medical subject headings
- Hyperhidrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBI-4000Drug
| Study group | Role | What they receive |
|---|---|---|
| Low Strength BBI-4000 and Vehicle | Experimental | Not described Receives: Drug: BBI-4000 |
| High Strength BBI-4000 and Vehicle | Experimental | Not described Receives: Drug: BBI-4000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in the gravimetrically measured sweat production from baseline
Measured: Week 2
Secondary outcomes (3)
Absolute change in the gravimetrically measured sweat production from baseline
Measured: Week 2
Proportion of subjects who have a minimum of 2-grade improvement in HDSS from baseline.
Measured: Week 2
Proportion of subjects who have a minimum of 1-grade improvement in HDSS from baseline
Measured: Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2014
- Study completionSep 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Botanix Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058264
- Sponsor's protocol ID
- BBI-4000-CL-101
- Status last verified
- Dec 2022
- First submitted
- 6 Feb 2014
- Last updated
- 16 Dec 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blinded, Vehicle-Controlled Study to Evaluate the Safety and the Effect on Sweat Production of Topically Applied BBI-4000 in Subjects With Hyperhidrosis.
- ClinicalTrials.gov ID
- NCT02058264
- Acronym / sponsor ID
- BBI-4000-CL-101
- Conditions
- Hyperhidrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Botanix PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 10 Feb 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.
The purpose of this study is to determine the safety, tolerability, pharmacokinetics and treatment effect of BBI-4000 when topically applied to subjects with axillary hyperhidrosis.
Detailed description
This is a randomized, vehicle controlled, double blind study in subjects with axillary hyperhidrosis designed to assess the safety, tolerability and the effect on sweat production of topically applied BBI-4000 for 14 days.
Safety will be assessed though vital signs, physical exam, adverse events, local skin reactions and laboratory tests (blood chemistry and hematology).
Efficacy will be assessed though the gravimetrically measured sweat production and the Hyperhidrosis Disease Severity Score (HDSS).
Pharmacokinetic information will also be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Strength BBI-4000 and Vehicle | Experimental | Drug: BBI-4000 |
| High Strength BBI-4000 and Vehicle | Experimental | Drug: BBI-4000 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or Female subjects from 18 to 45 years of age in good general health.
- Primary axillary hyperhidrosis of at least 6 months duration.
- Hyperhidrosis Disease Severity Score (HDSS) of 3 or 4 at baseline.
- Gravimetric test at baseline indicating at least 100mg of axillary sweat production in a 5 min period.
- Use of a medically appropriate contraceptive method.
Key exclusion criteria (7 listed)
- Prior axillary use of botulinum toxin within 2 years of study entry.
- Prior iontophoresis treatment for axillary hyperhidrosis within 12 weeks of study entry.
- Prior surgical procedures for hyperhidrosis or surgical procedures in the axillary areas for any reason.
- Use of anticholinergic treatment, beta-blocker, alpha-adrenergic or other prescription treatment for hyperhidrosis.
- History of diabetes mellitus, thyroid disease, malignancy, glaucoma, intestinal obstructive or motility disease, obstructive uropathy, myasthenia gravis, prostate hypertrophy, neurological conditions or cardiac abnormalities.
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 | Drug | High Strength BBI-4000 and Vehicle, Low Strength BBI-4000 and Vehicle |
Primary outcome
Percent change in the gravimetrically measured sweat production from baseline
Time frame: Week 2
3 secondary outcomes
Absolute change in the gravimetrically measured sweat production from baseline
Time frame: Week 2
Proportion of subjects who have a minimum of 2-grade improvement in HDSS from baseline.
Time frame: Week 2
Proportion of subjects who have a minimum of 1-grade improvement in HDSS from baseline
Time frame: Week 2
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 16 Dec 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BBI-4000 in people with Hyperhidrosis, run by Botanix Pharmaceuticals.
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 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 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Percent change in the gravimetrically measured sweat production from baseline (time frame: Week 2). 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 16 Dec 2022.