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Completed

NCT Number: NCT01490736

Phase 1/2 Sequentially Staged Safety Study in Healthy Subjects and 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.

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Key information

Conditions

Acne Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Innovaderm Research, Inc

Montreal, Quebec, H2K 4L5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lemuteporfin

Drug

lemuteporfin topical solution, 1%

Primary outcomes

  1. Change in sebum excretion rate

    Time frame: Baseline to Day 14

Secondary outcomes

  1. Change in biomarkers (e.g., caspase-3, CD163, neutrophil elastase)

    Time frame: Baseline to Day 14

  2. Change in acne lesion count

    Time frame: Baseline to Day 14

Sponsors and collaborators

Lead sponsor

Dermira, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 13, 2011
Registry last updated
Jul 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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