Indoor Daylight Photo Dynamic Therapy for Actinic Keratosis

Sponsor

Dartmouth-Hitchcock Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT03805737

Collaborator

Norris Cotton Cancer Center (Other)

Enrollment

Location

Arms

23.2

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Actinic Keratosis	Other: Amulez and sunlight Other: Amulez and red light treatment	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

43 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Indoor Daylight Photo Dynamic Therapy (PDT) for Actinic Keratosis

Actual Study Start Date :

Nov 1, 2019

Actual Primary Completion Date :

Oct 6, 2021

Actual Study Completion Date :

Oct 6, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Indoor Daylight PDT Therapy 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.	Other: Amulez and sunlight Amulez and sun exposure for 2 hours
Active Comparator: FDA Approved Standard Light Therapy 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.	Other: Amulez and red light treatment Amulez and red light treatment for 10 minutes

Arm

Intervention/Treatment

Experimental: Indoor Daylight PDT Therapy

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.

Other: Amulez and sunlight

Amulez and sun exposure for 2 hours

Active Comparator: FDA Approved Standard Light Therapy 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.

Other: Amulez and red light treatment

Amulez and red light treatment for 10 minutes

Outcome Measures

Primary Outcome Measures

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756

Sponsors and Collaborators

Dartmouth-Hitchcock Medical Center
Norris Cotton Cancer Center

Investigators

Principal Investigator: Michael Shane Chapman, MD, Dartmouth-Hitchcock Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Michael S. Chapman, Staff Physican, Dartmouth-Hitchcock Medical Center

ClinicalTrials.gov Identifier:

NCT03805737

Other Study ID Numbers:

D19030

First Posted:

Jan 16, 2019

Last Update Posted:

Jan 20, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Keratosis, Actinic

Keratosis

Study Results

No Results Posted as of Jan 20, 2022