Indoor Daylight Photo Dynamic Therapy for Actinic Keratosis

Not Applicable

Completed

• Conditions: Actinic Keratosis
• Interventions: Other: Amulez and sunlight; Other: Amulez and red light treatment

• Registration Number: NCT03805737
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief Summary

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.

Detailed 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

Study Timeline

• Study First Submitted: 2019-01-14
• Study First Submitted QC: 2019-01-15
• Study First Posted: 2019-01-16
• Study Start: 2019-11-01
• Primary Completion: 2021-10-06
• Study Completion: 2021-10-06
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-19
• Last Update Posted: 2022-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Indoor Daylight PDT Therapy	Amulez and sunlight	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.
FDA Approved Standard Light Therapy Treatment	Amulez and red light treatment	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.

Primary Outcome Measures

Name	Time	Method
Change in the amount of PpIX in the lesion	Baseline and immediately post procedure	Secondary diagnostic study to determine if low-cost cellphone-based skin dosimetry in PDT can facilitate objective measurement of drug levels.
Changes or clearing of the lesions	Baseline, immediately post-procedure (2 hours) and one and 6 months	The primary aim of this study is to study if indoor daylight PDT can be as effective as regular lamp light PDT. This study can be confounded by the amount of PpIX produced in the lesions as well as the clearing of lesions at one month and six months.

Trial Locations

Locations (1)

Dartmouth Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States