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

Phase 1

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Red Light (PDT)

• Registration Number: NCT01830764
• Lead Sponsor: Dermira, Inc.

Brief 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.

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 Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-10
• Study First Submitted QC: 2013-04-10
• Study First Posted: 2013-04-12
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-16
• Last Update Posted: 2021-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Red Light (PDT) 150 J/cm2	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
Red light dose (PDT) 75 J/cm2	Red Light (PDT)	Subjects in Cohort 1 will receive active and vehicle solution followed by a red light dose of 75 J/cm2 at 25 mW/cm2

Primary Outcome Measures

Name	Time	Method
Adverse Events	1 week	Adverse events and local tolerability assessed at pre and immediately post treatment, at Day 1 and Day 7 following treatment.

Trial Locations

Locations (1)

TKL Research Inc (Research Clinics Division); 🇺🇸 Paramus, New Jersey, United States