A Safety, Tolerability and Preliminary Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis
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|ClinicalTrials.gov Identifier: NCT02058264|
Recruitment Status : Completed
First Posted : February 10, 2014
Last Update Posted : September 11, 2014
|Condition or disease||Intervention/treatment||Phase|
|Hyperhidrosis||Drug: BBI-4000||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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.|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||September 2014|
|Experimental: Low Strength BBI-4000 and Vehicle||
|Experimental: High Strength BBI-4000 and Vehicle||
- Percent change in the gravimetrically measured sweat production from baseline [ Time Frame: Week 2 ]
- 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 ]
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): NCT02058264
|Santo Domingo, Dominican Republic|
|Study Director:||David Angulo, M.D.||Brickell Biotech, Inc.|
|Principal Investigator:||Daisy Blanco, M.D.||Instituto Dermatologico|