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

Dermira

Status and phase

Completed

Phase 2

Phase 1

Conditions

Acne

Treatments

Drug: Lemuteporfin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01490736

LTS ACN-05

Details and patient eligibility

About

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.

Full 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.

Enrollment

129 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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