Efficacy, Safety, and Tolerability of HTS-519 Insert in Patients With Toenail Fungus of the Big Toenail
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02798380|
Recruitment Status : Active, not recruiting
First Posted : June 14, 2016
Last Update Posted : May 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Onychomycosis||Drug: HTS-519 Insert||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Phase 2 Study to Investigate the Efficacy, Tolerability, and Safety of the HTS-519 Insert in the Treatment of Subjects With Distal Lateral Subungual Onychomycosis of the Great Toenail|
|Actual Study Start Date :||July 2016|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2018|
Experimental: HTS-519 Insert
Drug: HTS-519 Insert
Maximum feasible dose of HTS-519 Insert per diseased nail
Other Name: HTS-519 Biodegradable Micro Insert
- Complete Cure [ Time Frame: Week 48 ]Complete cure is defined as negative KOH microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.
- Complete Cure [ Time Frame: Week 24 and 36 ]Complete cure is defined as negative KOH microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.
- Effective Treatment [ Time Frame: Week 24, 36 and 48 ]Effective treatment is defined as negative KOH microscopy and negative culture for dermatophytes and ≤ 10% residual involvement of the target toenail.
- Clinical Cure [ Time Frame: Week 12, 16, 20, 24, 36 and 48 ]Clinical cure is defined as no residual involvement of the target toenail.
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): NCT02798380
|United States, Arizona|
|Physicians Research Group|
|Mesa, Arizona, United States, 85206|
|Study Chair:||Mark Taylor||Hallux, Inc.|