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

NCT ID: NCT01830764

Last Updated: 2021-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2013-06-30

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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Red Light (PDT)

Intervention Type: DRUG

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

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

Group Type: OTHER

Red Light (PDT)

Intervention Type: DRUG

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

Interventions

Red Light (PDT)

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

Intervention Type: DRUG

Other Intervention Names

LTS-PDT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dermira, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan S Dosik, MD

Role: PRINCIPAL_INVESTIGATOR

TKL Research Inc (Research Clinics Division)

Locations

TKL Research Inc (Research Clinics Division)

Paramus, New Jersey, United States

Countries

United States

Other Identifiers

LTS-ACN06

Identifier Type: -

Identifier Source: org_study_id