Indoor Daylight Photo Dynamic Therapy for Actinic Keratosis

Dartmouth Health

Status: Completed

Conditions: Actinic Keratosis

Treatments: Other: Amulez and red light treatment; Other: Amulez and sunlight

Study type: Interventional

Funder types: Other

Identifiers

NCT03805737

D19030

Details and patient eligibility

About

The purpose of this study is to understand better if indoor daylight Photo Dynamic Therapy (PDT) can provide effective lesion clearing versus conventional red lamp light therapy.

Full description

Subjects who enroll into this research study, their participation in this study will last up to 6 months. They will be asked to return to the clinic 3-4 times.

Subjects will be randomized into one of two study arms:

Arm 1 - Indoor Daylight PDT Therapy Arm 2 - FDA Approved Standard Light Therapy Treatment

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients with actinic keratosis appearing at the Dermatology Clinic for PDT treatment.
• Age ≥ 18 years older.

Exclusion criteria

• Pregnant women or women who are breast-feeding.
• Any patients with a condition that makes them not suitable for clinical PDT.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

Indoor Daylight PDT Therapy

Experimental group

Description:

Ameluz will be applied to skin. This will be followed by a 30-minute incubation period. Subsequently, you will be exposed to natural sunlight through a window for 2 hours. Post-treatment assessments will be performed and you will be given instruction on appropriate sun protection methods.

Treatment:

Other: Amulez and sunlight

FDA Approved Standard Light Therapy Treatment

Active Comparator group

Description:

Ameluz will be applied to skin. This will be followed by a 30-minute incubation period. Subsequently, you will receive Red Light Treatment for 10 minutes. Post-treatment assessments will be performed and you will be given instruction on appropriate sun protection methods.

Treatment:

Other: Amulez and red light treatment