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

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ClinicalTrials.gov Identifier: NCT01830764
Recruitment Status : Completed
First Posted : April 12, 2013
Last Update Posted : September 9, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Red Light (PDT) Phase 1

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  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Safety and Tolerability Study of LTS 0.3% With Red Light Applied to the Backs of Healthy Volunteers
Study Start Date : April 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Arm Intervention/treatment
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 Name: LTS-PDT
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 Name: LTS-PDT



Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 1 week ]
    Adverse events and local tolerability assessed at pre and immediately post treatment, at Day 1 and Day 7 following treatment.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01830764


Locations
United States, New Jersey
TKL Research Inc (Research Clinics Division)
Paramus, New Jersey, United States, 07652
Sponsors and Collaborators
Dermira, Inc.
Investigators
Principal Investigator: Jonathan S Dosik, MD TKL Research Inc (Research Clinics Division)

Responsible Party: Dermira, Inc.
ClinicalTrials.gov Identifier: NCT01830764     History of Changes
Other Study ID Numbers: LTS-ACN06
First Posted: April 12, 2013    Key Record Dates
Last Update Posted: September 9, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases