A Phase 1 interventional study of Red Light (PDT) in Acne Vulgaris, sponsored by Dermira, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-20.
Sponsored by Dermira, Inc. · Phase 1, Interventional, and Treatment
The purpose of this study is assess the safety and tolerability of lemuteporfin topical solution (LTS) with exposure to red light (PDT), when applied to the backs of healthy volunteers.
This is an open-label, safety study in healthy volunteers. Two cohorts, of 6 subjects each, will be enrolled (total subjects = 12). Each subject will have test areas identified on the back and receive a single LTS, vehicle solution and red light (PDT) applied to the test areas on the back. Subjects will be followed for safety at study visits occurring on Day 1 (baseline and treatment), Day 2, and Day 7.
730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.
This study's enrollment of 12 is below the median of 69 across 628 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Dermira, Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects in Cohort 1 will receive active and vehicle solution followed by a red light dose of 75 J/cm2 at 25 mW/cm2
Drug: Red Light (PDT)
Subjects in Cohort 2 will receive active and vehicle solution followed by a red light dose of 150 J/cm2 at 40 mW/cm2
Drug: Red Light (PDT)
LTS, 0.3% applied topically followed by red light dose (75 J/cm2 or 150 J/cm2)
Also known as: LTS-PDT
Adverse Events
Adverse events and local tolerability assessed at pre and immediately post treatment, at Day 1 and Day 7 following treatment.
Time frame: 1 week
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Dermira, Inc.