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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acne

Intervention / Treatment
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* Drug: Lemuteporfin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LTS/Vehicle<br>Within subject control study | Drug: Lemuteporfin<br>* lemuteporfin topical solution, 1%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sebum excretion rate |  | Baseline to Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acne, Sebum gland disease