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

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01830764
• Other study ID #: LTS-ACN06
• Status: Completed
• Phase: Phase 1
• Start date: April 2013
• Est. completion date: June 2013

Study information

• Verified date: July 2021
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Red Light (PDT)
LTS, 0.3% applied topically followed by red light dose (75 J/cm2 or 150 J/cm2)

Locations

Country	Name	City	State
United States	TKL Research Inc (Research Clinics Division)	Paramus	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Dermira, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Adverse events and local tolerability assessed at pre and immediately post treatment, at Day 1 and Day 7 following treatment.	1 week