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

NCT01830764 | Completed Phase 1

• 1 other identifier: LTS-ACN06
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Adverse events and local tolerability assessed at pre and immediately post treatment, at Day 1 and Day 7 following treatment.

  1 week

Study Arms (2)

Red light dose (PDT) 75 J/cm2

OTHER

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)

Red Light (PDT) 150 J/cm2

OTHER

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)

Interventions

Red Light (PDT) DRUG

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

Also known as: LTS-PDT

Red Light (PDT) 150 J/cm2; Red light dose (PDT) 75 J/cm2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults 18 years of age or older
• Fitzpatrick skin types I-IV

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dermira, Inc.: lead

Study Sites (1)

TKL Research Inc (Research Clinics Division)

Paramus, New Jersey, 07652, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Photochemotherapy

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• Jonathan S Dosik, MD

  TKL Research Inc (Research Clinics Division)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2013
• First Posted: April 12, 2013
• Study Start: April 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 20, 2021

Record last verified: 2021-07

Locations

US (1)