Completed

Safety and Tolerability of LTS 0.3% and Red Light in Healthy Volunteers

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Study Aim

This study aims to evaluate the safety and tolerability of LTS 0.3% and Red Light treatment in healthy volunteers, by assessing any adverse events and local tolerability at various time points following treatment.

What is being tested

Red Light (PDT)

+ Red Light (PDT)

Drug
Who is being recruted

Sebaceous Gland Diseases+2

+ Skin Diseases

+ Skin and Connective Tissue Diseases

Over 18 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorDermira, Inc.
Last updated: July 20, 2021
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01830764
Principal SponsorDermira, Inc.
Last updated: July 20, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

12 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Sebaceous Gland DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAcneiform EruptionsAcne Vulgaris

Criteria

2 inclusion criteria required to participate
Fitzpatrick skin types I-IV
Healthy adults 18 years of age or older
10 exclusion criteria prevent from participating
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
Chronic treatment with low dose aspirin, a non-steroidal anti inflammatory drug (NSAID), or an anticoagulant regimen such as warfarin (Coumadin)
Current pregnancy or lactation
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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 II

Subjects in Cohort 2 will receive active and vehicle solution followed by a red light dose of 150 J/cm2 at 40 mW/cm2

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

TKL Research Inc (Research Clinics Division)

Paramus, United StatesOpen TKL Research Inc (Research Clinics Division) in Google Maps
CompletedOne Study Center