A Safety Study of BBI-4000 Gel in Pediatric Patients With Axillary Hyperhidrosis
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|ClinicalTrials.gov Identifier: NCT03785587|
Recruitment Status : Active, not recruiting
First Posted : December 24, 2018
Last Update Posted : March 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Primary Axillary Hyperhidrosis||Drug: Sofpironium Bromide Gel, 15%||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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, ≥9 to <17 Years of Age, Previously Enrolled in BBI-4000-CL-105|
|Actual Study Start Date :||December 21, 2018|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
Experimental: Gel, 15%
Sofpironium Bromide Gel, 15%, q.d. for 24 weeks
Drug: Sofpironium Bromide Gel, 15%
Sofpironium Bromide Gel, 15%
Other Name: BBI-4000
- The number of participants with treatment emergent adverse events. [ Time Frame: Through study completion (24 weeks). ]Summarized by MedDRA LLT with a 3 point severity scale of mild, moderate and severe.
- The number of participants with dermal tolerability symptoms of burning, stinging, itching, scaling or erythema to the axillae. [ Time Frame: Through study completion (24 weeks). ]Symptoms rated on a 5-point scale (0=absent, 1=minimal, 2=mild,-3=moderate, 4=severe).
- The systemic exposure (Ctrough) of sofpironium and its primary metabolite (BBI-4010) [ Time Frame: Through study completion (24 weeks). ]Trough levels of sofpironium based on sampling schedule.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03785587
|United States, Arkansas|
|Northwest Arkansas Clinical Trials Center|
|Rogers, Arkansas, United States, 72758|
|Study Director:||Lawrence Romel, MS||Brickell Biotech, Inc.|