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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dermira, Inc.
ClinicalTrials.gov Identifier:
NCT01490736
First received: December 7, 2011
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Acne
Drug: Lemuteporfin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 1/2 Study of Photodynamic Therapy (PDT) With Lemuteporfin Topical Solution (LTS) in Healthy Volunteers and in Subjects With Mild Acne

Resource links provided by NLM:


Further study details as provided by Dermira, Inc.:

Primary Outcome Measures:
  • Change in sebum excretion rate [ Time Frame: Baseline to Day 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in biomarkers (e.g., caspase-3, CD163, neutrophil elastase) [ Time Frame: Baseline to Day 14 ] [ Designated as safety issue: No ]
  • Change in acne lesion count [ Time Frame: Baseline to Day 14 ] [ Designated as safety issue: No ]

Enrollment: 129
Study Start Date: December 2011
Study Completion Date: June 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LTS/Vehicle
Within subject control study
Drug: Lemuteporfin
lemuteporfin topical solution, 1%

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01490736

Locations
Canada, Quebec
Innovaderm Research, Inc
Montreal, Quebec, Canada, H2K 4L5
Sponsors and Collaborators
Dermira, Inc.
Investigators
Principal Investigator: Robert Bissonnette, MD Innovaderm
  More Information

No publications provided

Responsible Party: Dermira, Inc.
ClinicalTrials.gov Identifier: NCT01490736     History of Changes
Other Study ID Numbers: LTS ACN-05
Study First Received: December 7, 2011
Last Updated: July 23, 2013
Health Authority: Canada: Health Canada

Keywords provided by Dermira, Inc.:
Acne
Sebum gland disease

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

ClinicalTrials.gov processed this record on April 16, 2014