Efficacy, Safety, and Tolerability of HTS-519 Insert in Patients With Mild to Moderate Toenail Fungus of the Big Toenail
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|ClinicalTrials.gov Identifier: NCT02798380|
Recruitment Status : Recruiting
First Posted : June 14, 2016
Last Update Posted : August 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Onychomycosis||Drug: HTS-519 Insert||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated 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 :||July 2018|
|Estimated Study Completion Date :||July 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
|Contact: Henk-Andre Kroon, MDfirstname.lastname@example.org|
|United States, Arizona|
|Physicians Research Group||Recruiting|
|Mesa, Arizona, United States, 85206|
|Contact: Robert Wallace 480-889-1211 email@example.com|
|Study Director:||Henk-Andre Kroon, MD||Hallux, Inc.|