A Confirmatory Safety and Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis (NCT03024255) | Clinical Trial Compass
CompletedPhase 2
A Confirmatory Safety and Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis
227 participantsStarted 2016-12-22
Plain-language summary
This study is being conducted to assess the safety and efficacy of 3 concentrations of BBI-4000 and vehicle (4 treatment arms), applied for the treatment of axillary hyperhidrosis.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female subject ≥ 18 years of age.
* Diagnosis of primary axillary hyperhidrosis that meets the following criteria: (a) symptoms of hyperhydrosis for at least 6 months' duration, (b) HDSM-Ax of 3 - 4, (c) HDSS of 3 or 4 and (d) a minimum GSP of 50 mg is each axilla with a combined total of at least 150 mg.
* The ability to understand and follow all study-related procedures including study drug administration.
* Sexually active female of childbearing potential (FOCBP)\* must agree to periodic pregnancy testing and use a medically acceptable method of contraception while receiving protocol-assigned product.
Exclusion Criteria:
* In the Investigators opinion, any skin or subcutaneous tissue conditions of the axilla(s).
* Prior use of any prohibited medication(s) or procedure(s) within the specified timeframe for the treatment of axillary hyperhidrosis.
* Anticholinergic agents used to treat conditions such as, but not limited to, hyperhidrosis, asthma, incontinence, gastrointestinal cramps, and muscular spasms by any route of administration.
* Use of potent inhibitors of cytochrome P450 CYP3A and CYP2D6.
* Use of any cholinergic drug (e.g. bethanechol) within 30 days.
* Known cause of hyperhidrosis or known history of a condition that may cause hyperhidrosis (i.e., hyperhidrosis secondary to any known cause such hyperthyroidism, diabetes mellitus, medications, etc.).
* Subjects with unstable diabetes mellitus or thyroid disease, history of renal o…
What they're measuring
1
Change of Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) Score From Baseline to End of Therapy
Timeframe: overall ~6 Weeks, as listed in description includes: Baseline-Visit 1, Visit 4 and End of Therapy Visit - Days 41, 42, 43.
2
Number (%) of Subjects Reporting at Least One Treatment Emergent Adverse Event by Severity
Timeframe: Treatment initiation through end of treatment (~42 days) and subsequent safety f/u (~14 days following end of treatment)