Phase 1/2 Sequentially Staged Safety Study in Healthy Subjects and Subjects With Mild Acne

July 16, 2021 updated by: Dermira, Inc.

Phase 1/2 Study of Photodynamic Therapy (PDT) With Lemuteporfin Topical Solution (LTS) in Healthy Volunteers and in Subjects With Mild Acne

The purpose of this study is to determine the safety of photodynamic therapy (PDT) with lemuteporfin topical solution (LTS) in healthy subjects and subjects with mild acne.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a sequentially staged (Stage 1-4), proof of concept study assessing the safety of photodynamic therapy (PDT) and lemuteporfin topical solution (LTS) in healthy subjects and subjects with mild acne. Approximately 12 subjects will be enrolled in Stage 1 in order to determine a maximum tolerated light dose following LTS application. Up to 90 subjects with mild acne will be enrolled in Stage 2 in order to assess the safety of PDT following a single LTS application. Up to 50 subjects will be enrolled in Stage 3 in order to assess the safety of PDT following repeat LTS applications. Up to 40 subjects will be enrolled into Stage 4 to assess multiple treatments of LTS-PDT.

Study Type

Interventional

Enrollment (Actual)

129

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2K 4L5
        • Innovaderm Research, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stage 1 only: healthy subjects
  • Stage 1-4: male or female subjects age 18 years or older
  • Stage 2: subjects with sebum excretion rate of 4 or higher on forehead
  • Stage 2-4: subjects with at least 2 inflammatory acne lesions on the forehead
  • Stage 3-4: subjects with sebum excretion rate of 5 or higher on forehead

Exclusion Criteria:

  • Poor skin condition on back (Stage 1) or face (Stage 2 & 3)
  • Severe facial acne, acne fluminans/conglobata, or nodulocystic acne
  • Stage 2-4: previous use of Diane-35 within 6 months of Day 0, systemic acne treatment or systemic antibiotic treatment within 28 days of Day 0, topical acne treatment to the face within 14days of Day 0 or PDT to the face within 3 months of Day 0
  • Stage 2-4: previous treatment of isotretinoin or other oral retinoids

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LTS/Vehicle
Within subject control study
Drug: Lemuteporfin
lemuteporfin topical solution, 1%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in sebum excretion rate
Time Frame: Baseline to Day 14
Baseline to Day 14

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in biomarkers (e.g., caspase-3, CD163, neutrophil elastase)
Time Frame: Baseline to Day 14
Baseline to Day 14
Change in acne lesion count
Time Frame: Baseline to Day 14
Baseline to Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dermira, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

December 7, 2011

First Submitted That Met QC Criteria

December 9, 2011

First Posted (Estimate)

December 13, 2011

Study Record Updates

Last Update Posted (Actual)

July 20, 2021

Last Update Submitted That Met QC Criteria

July 16, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LTS ACN-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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