Back to resultsOpen-label Safety and Tolerability Study of LTS-PDT in Healthy Volunteers
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Red Light (PDT)
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris
Eligibility Criteria
Inclusion Criteria:
- Healthy adults 18 years of age or older
- Fitzpatrick skin types I-IV
Exclusion Criteria:
- Current pregnancy or lactation.
- Presence of severe facial acne, acne fulminans or conglobata, or nodulocystic acne.
- Poor skin condition on the back, including erythema, dryness, sunburn, dermatological malignancies, infections, cuts, abrasions, tattoo, excess of hair or any other skin condition
- 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.
- Subjects who have used any medicated topical therapy on the back within 3 days of Day 1.
- Chronic treatment with low dose aspirin, a non-steroidal anti inflammatory drug (NSAID), or an anticoagulant regimen such as warfarin (Coumadin).
- Abnormal findings on screening ECG deemed clinically significant by the Investigator.
- Active participation in an experimental therapy study or experimental therapy within 30 days of Day 1.
- Screening clinical chemistry or hematology laboratory value that is considered clinically significant, in the opinion of the Investigator.
- Subjects who are a poor medical risk because of other systemic diseases or active uncontrolled infections.
Sites / Locations
- TKL Research Inc (Research Clinics Division)
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Red light dose (PDT) 75 J/cm2
Red Light (PDT) 150 J/cm2
Arm Description
Subjects in Cohort 1 will receive active and vehicle solution followed by a red light dose of 75 J/cm2 at 25 mW/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
Outcomes
Primary Outcome Measures
Adverse Events
Adverse events and local tolerability assessed at pre and immediately post treatment, at Day 1 and Day 7 following treatment.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01830764
Brief Title
Open-label Safety and Tolerability Study of LTS-PDT in Healthy Volunteers
Official Title
An Open-label Safety and Tolerability Study of LTS 0.3% With Red Light Applied to the Backs of Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dermira, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Red light dose (PDT) 75 J/cm2
Arm Type
Other
Arm Description
Subjects in Cohort 1 will receive active and vehicle solution followed by a red light dose of 75 J/cm2 at 25 mW/cm2
Arm Title
Red Light (PDT) 150 J/cm2
Arm Type
Other
Arm Description
Subjects in Cohort 2 will receive active and vehicle solution followed by a red light dose of 150 J/cm2 at 40 mW/cm2
Intervention Type
Drug
Intervention Name(s)
Red Light (PDT)
Other Intervention Name(s)
LTS-PDT
Intervention Description
LTS, 0.3% applied topically followed by red light dose (75 J/cm2 or 150 J/cm2)
Primary Outcome Measure Information:
Title
Adverse Events
Description
Adverse events and local tolerability assessed at pre and immediately post treatment, at Day 1 and Day 7 following treatment.
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy adults 18 years of age or older
Fitzpatrick skin types I-IV
Exclusion Criteria:
Current pregnancy or lactation.
Presence of severe facial acne, acne fulminans or conglobata, or nodulocystic acne.
Poor skin condition on the back, including erythema, dryness, sunburn, dermatological malignancies, infections, cuts, abrasions, tattoo, excess of hair or any other skin condition
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.
Subjects who have used any medicated topical therapy on the back within 3 days of Day 1.
Chronic treatment with low dose aspirin, a non-steroidal anti inflammatory drug (NSAID), or an anticoagulant regimen such as warfarin (Coumadin).
Abnormal findings on screening ECG deemed clinically significant by the Investigator.
Active participation in an experimental therapy study or experimental therapy within 30 days of Day 1.
Screening clinical chemistry or hematology laboratory value that is considered clinically significant, in the opinion of the Investigator.
Subjects who are a poor medical risk because of other systemic diseases or active uncontrolled infections.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan S Dosik, MD
Organizational Affiliation
TKL Research Inc (Research Clinics Division)
Official's Role
Principal Investigator
Facility Information:
Facility Name
TKL Research Inc (Research Clinics Division)
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Open-label Safety and Tolerability Study of LTS-PDT in Healthy Volunteers
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