Primary Axillary Hyperhidrosis Clinical Trial
Official title:
A Multi-Center Open-Label Extension Study to Assess the Long-Term Safety Tolerability and Pharmacokinetics of Sofpironium Bromide Gel 15% Applied Topically to Children and Adolescents Age 9-17 Years Previously Enrolled in BBI-4000-CL-105
Hyperhidrosis is a disorder of abnormal excessive sweating. Primary hyperhidrosis (armpits, hands, and feet) affects approximately 4.8% of the US population and is believed to be caused by an overactive cholinergic response of the sweat glands. Sofpironium bromide (BBI-4000) is a novel soft-drug in development for the topical treatment of hyperhidrosis. This Phase 2 study will assess the long-term safety, tolerability, pharmacokinetics and efficacy of sofpironium bromide gel applied topically to pediatric subjects with axillary hyperhidrosis.
This is an open-label, phase 2 long-term study designed to evaluate the safety, local tolerability, pharmacokinetics and efficacy of sofpironium bromide gel when applied topically to the axillae. Subjects will apply the gel once daily at bedtime, to both axillae. A maximum of 24 subjects, will be enrolled to receive sofpironium bromide gel, 15%. Adverse events, vital signs, and local tolerability assessments will be collected at each visit. Urine pregnancy tests will be taken throughout the course of the study for women of child bearing potential. Blood and urine samples will be collected and analyzed for pharmacokinetics, routine hematology, chemistry, and urinalysis parameters at specified visits. Patient-reported outcome assessments will be recorded during the study at predefined time points. The study will be comprised of a total of 8 scheduled visits to take place over a 26 week period. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03627468 -
A Safety Study of BBI-4000 Gel in Patients With Axillary Hyperhidrosis
|
Phase 3 | |
| Completed |
NCT03658616 -
Assessment of Efficacy and Safety of Topical Administration of 1% Glycopyrronium Bromide (GPB) in Patients With Primary Axillary Hyperhidrosis and the Assessment of Long-term Efficacy and Safety of Topical Administration of 1% GPB Cream in Patients With Primary Axillary Hyperhidrosis.
|
Phase 3 | |
| Completed |
NCT02286765 -
Ulthera® System for Treating Axillary Hyperhidrosis
|
N/A | |
| Completed |
NCT04599907 -
Evaluation of N-SWEAT Patch for Treatment of Primary Axillary Hyperhidrosis or Excessive Axillary Sweating
|
N/A | |
| Completed |
NCT03037788 -
Investigation of Ascending Concentrations of Glycopyrronium Bromide (GPB) in a Topical Formulation in Subjects With Axillary Hyperhidrosis
|
Phase 1 | |
| Terminated |
NCT01722461 -
A Study of the Ulthera® System for the Treatment of Axillary Hyperhidrosis
|
N/A | |
| Completed |
NCT05863104 -
Assessment of Safety, Tolerability, Systemic Exposure and Efficacy of GPB Cream in Adolescents With Severe Primary Hyperhidrosis
|
Phase 2 | |
| Completed |
NCT02823340 -
Fractionated Microneedle Radiofrequency for Treatment of Primary Axillary Hyperhidrosis
|
N/A | |
| Not yet recruiting |
NCT04159610 -
Assessment of Safety, Tolerability and Efficacy of 1% GPB Cream Versus Qbrexza® (Glycopyrronium) Cloth 2.4% Under Maximum-Use Conditions in Subjects With Primary Axillary Hyperhidrosis
|
Phase 2 | |
| Completed |
NCT01799824 -
Clinical Trial to Evaluate ANT-1403 in the Treatment of Primary Axillary Hyperhidrosis
|
Phase 2 | |
| Completed |
NCT03054480 -
Fractional Micro-Needle Radiofrequency and I Botulinum Toxin A for Primary Axillary Hyperhidrosis
|
N/A |