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

Phase 1/2 Study of Photodynamic Therapy (PDT) With Lemuteporfin Topical Solution (LTS) in Healthy Volunteers and in Subjects With Mild Acne

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01490736

Enrollment

129

Registered

2011-12-13

Start date

2011-12-31

Completion date

2013-06-30

Last updated

2021-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne

Keywords

Acne, Sebum gland disease

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.

Interventions

DRUGLemuteporfin

lemuteporfin topical solution, 1%

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Change in sebum excretion rate	Baseline to Day 14

Secondary

Measure	Time frame
Change in biomarkers (e.g., caspase-3, CD163, neutrophil elastase)	Baseline to Day 14
Change in acne lesion count	Baseline to Day 14

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026