Status:
COMPLETED
Phase 1/2 Sequentially Staged Safety Study in Healthy Subjects and Subjects With Mild Acne
Lead Sponsor:
Dermira, Inc.
Conditions:
Acne
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT01490736
Start Date
December 1 2011
End Date
June 1 2013
Last Update
July 20 2021
Active Locations (1)
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1
Innovaderm Research, Inc
Montreal, Quebec, Canada, H2K 4L5