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

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dermira, Inc.

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