A Phase 1 interventional study of ALA 10% gel and PDT in Onychomycosis of Toenail, sponsored by The University of Texas Health Science Center, Houston. Active, not recruiting at 3 sites in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by The University of Texas Health Science Center, Houston · Phase 1, Interventional, and Treatment
The purpose of this study is clinical and mycological clearance of onychomycosis using photodynamic therapy (PDT) with aminolevulinic acid (ALA) 10% gel at 6 months, 3 months, 9 months and 12 months
158 studies on the registry are indexed under Onychomycosis; 16 are open to participants now.
This study's planned enrollment of 5 is below the median of 60 across 143 interventional studies indexed under Onychomycosis.
Browse Onychomycosis studies →The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.
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Exclusion Criteria:
Drug: ALA 10% gel · Device: PDT · Drug: Urea
ALA 10% gel will be applied under occlusion for 3 hours before PDT
Participants will have illumination on the affected nail with RhodoLED® XL 635 nm red light at 37 J/cm² at 5 inches for 13.5 minutes.
Participants will have 20% urea applied to affected nail daily for 2 weeks before start of treatment
Number of participants that show Clinical clearance of onychomycosis
Clinical clearance is indicated by lack of nail thickening (subungual hyperkeratosis), nail-plate separation (onycholysis) and white/yellow/orange/brown discoloration
Time frame: 6 months after treatment
Number of participants that show mycological clearance of onychomycosis as indicated by a negative KOH testing result
Time frame: 6 months after treatment
Number of participants that show Clinical clearance of onychomycosis nail thickening (subungual hyperkeratosis), nail-plate separation (onycholysis), and white/yellow/orange/brown discoloration
Clinical clearance is indicated by lack of nail thickening (subungual hyperkeratosis), nail-plate separation (onycholysis) and white/yellow/orange/brown discoloration
Time frame: 3 months
Number of participants that show Clinical clearance of onychomycosis nail thickening (subungual hyperkeratosis), nail-plate separation (onycholysis), and white/yellow/orange/brown discoloration
Clinical clearance is indicated by lack of nail thickening (subungual hyperkeratosis), nail-plate separation (onycholysis) and white/yellow/orange/brown discoloration
Time frame: 9 months
Number of participants that show Clinical clearance of onychomycosis
Clinical clearance is indicated by lack of nail thickening (subungual hyperkeratosis), nail-plate separation (onycholysis) and white/yellow/orange/brown discoloration
Time frame: 12 months
Number of participants that show Mycological clearance of onychomycosis as indicated by a negative KOH testing result
Time frame: 3 months
Number of participants that show Mycological clearance of onychomycosis as indicated by a negative KOH testing result
Time frame: 9 months
Number of participants that show Mycological clearance of onychomycosis as indicated by a negative KOH testing result
Time frame: 12 months
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Alpha-Linolenic Acid · Urea
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