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CompletedNCT01830764Updated Jul 20, 2021

Open-label Safety and Tolerability Study of LTS-PDT in Healthy Volunteers

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

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Acne Vulgaris

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03

In context

Acne Vulgaris

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy adults 18 years of age or older
  2. Fitzpatrick skin types I-IV

Exclusion criteria

Exclusion Criteria:

  1. Current pregnancy or lactation.
  2. Presence of severe facial acne, acne fulminans or conglobata, or nodulocystic acne.
  3. Poor skin condition on the back, including erythema, dryness, sunburn, dermatological malignancies, infections, cuts, abrasions, tattoo, excess of hair or any other skin condition
  4. Subjects who have used any agents known to produce significant photosensitivity reactions (tetracyclines, phenothiazines, trimethoprim, etc.) within 2 weeks of Day 1 or 5 half-lives, whichever is longer.
  5. Subjects who have used any medicated topical therapy on the back within 3 days of Day 1.
  6. Chronic treatment with low dose aspirin, a non-steroidal anti inflammatory drug (NSAID), or an anticoagulant regimen such as warfarin (Coumadin).
  7. Abnormal findings on screening ECG deemed clinically significant by the Investigator.
  8. Active participation in an experimental therapy study or experimental therapy within 30 days of Day 1.
  9. Screening clinical chemistry or hematology laboratory value that is considered clinically significant, in the opinion of the Investigator.
  10. Subjects who are a poor medical risk because of other systemic diseases or active uncontrolled infections.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Other
    Red light dose (PDT) 75 J/cm2

    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)

  • Other
    Red Light (PDT) 150 J/cm2

    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)

Interventions

  • DrugRed Light (PDT)

    LTS, 0.3% applied topically followed by red light dose (75 J/cm2 or 150 J/cm2)

    Also known as: LTS-PDT

06

What researchers measure

Primary outcomes

  1. 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

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Study locations

1 site
  • TKL Research Inc (Research Clinics Division)
    Paramus, New Jersey 07652, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01830764
Lead sponsor
Dermira, Inc.
Responsible party
Sponsor
First posted
Apr 12, 2013
Start date
Apr 2013
Primary completion
Jun 2013
Completion
Jun 2013
Last update
Jul 20, 2021

Study contacts

Jonathan S Dosik, MD
principal investigator · TKL Research Inc (Research Clinics Division)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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