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

An Open-label Safety and Tolerability Study of LTS 0.3% With Red Light Applied to the Backs of Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Red Light (PDT)

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); LTS, 0.3% applied topically followed by red light dose (75 J/cm2 or 150 J/cm2); Other Names: LTS-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); LTS, 0.3% applied topically followed by red light dose (75 J/cm2 or 150 J/cm2); Other Names: LTS-PDT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Adverse events and local tolerability assessed at pre and immediately post treatment, at Day 1 and Day 7 following treatment.	1 week

Collaborators and Investigators

• Sponsor: Dermira, Inc.
• Investigators: Principal Investigator: Jonathan S Dosik, MD, TKL Research Inc (Research Clinics Division)

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: April 10, 2013
• First Submitted That Met QC Criteria: April 10, 2013
• First Posted (Estimate): April 12, 2013

Study Record Updates

• Last Update Posted (Actual): July 20, 2021
• Last Update Submitted That Met QC Criteria: July 16, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: LTS-ACN06