Back to resultsPhase 1/2 Sequentially Staged Safety Study in Healthy Subjects and Subjects With Mild Acne
Primary Purpose
Acne
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Lemuteporfin
Sponsored by
About this trial
This is an interventional treatment trial for Acne focused on measuring Acne, Sebum gland disease
Eligibility 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
Sites / Locations
- Innovaderm Research, Inc
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LTS/Vehicle
Arm Description
Within subject control study
Outcomes
Primary Outcome Measures
Change in sebum excretion rate
Secondary Outcome Measures
Change in biomarkers (e.g., caspase-3, CD163, neutrophil elastase)
Change in acne lesion count
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01490736
Brief Title
Phase 1/2 Sequentially Staged Safety Study in Healthy Subjects and Subjects With Mild Acne
Official Title
Phase 1/2 Study of Photodynamic Therapy (PDT) With Lemuteporfin Topical Solution (LTS) in Healthy Volunteers and in Subjects With Mild Acne
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dermira, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne
Keywords
Acne, Sebum gland disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
N/A
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LTS/Vehicle
Arm Type
Experimental
Arm Description
Within subject control study
Intervention Type
Drug
Intervention Name(s)
Lemuteporfin
Intervention Description
lemuteporfin topical solution, 1%
Primary Outcome Measure Information:
Title
Change in sebum excretion rate
Time Frame
Baseline to Day 14
Secondary Outcome Measure Information:
Title
Change in biomarkers (e.g., caspase-3, CD163, neutrophil elastase)
Time Frame
Baseline to Day 14
Title
Change in acne lesion count
Time Frame
Baseline to Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Bissonnette, MD
Organizational Affiliation
Innovaderm Research Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Innovaderm Research, Inc
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2K 4L5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Phase 1/2 Sequentially Staged Safety Study in Healthy Subjects and Subjects With Mild Acne
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