Photodynamic Therapy Incubation Times for Actinic Keratosis

NCT ID: NCT03066843

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2025-12-31

Brief Summary

This is a randomized clinical trial evaluating blue light 5-aminolevulinic acid (ALA) photodynamic therapy with different incubation times for the treatment of actinic keratosis.

Subjects who are interested in participating, currently living in the Chicago metropolitan area, and meet inclusion and exclusion criteria will be enrolled in the study. Subjects will be randomized to either 1) zero time ALA incubation or 2) 1 hour ALA incubation. Demographic and health data will be collected prior to treatment initiation. Three visits will be conducted: screening, treatment, and follow up visit at 8 weeks.

This study is a pilot study designed to determine feasibility of this procedure.

Conditions

Actinic Keratoses

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Zero incubation with ALA (5-aminolevulinic acid)

Subjects will receive zero time of incubation with ALA (5-aminolevulinic acid) before photodynamic blue light therapy.

Group Type: EXPERIMENTAL

ALA (5-aminolevulinic acid)

Intervention Type: DRUG

ALA (5-aminolevulinic acid) will be applied to subjects' skin for either zero time incubation or one hour incubation

Blue light therapy

Intervention Type: DEVICE

Subjects will be exposed to blue light

One hour incubation with ALA (5-aminolevulinic acid)

Subjects will receive one hour of incubation with ALA (5-aminolevulinic acid) before photodynamic blue light therapy.

Group Type: EXPERIMENTAL

ALA (5-aminolevulinic acid)

Intervention Type: DRUG

ALA (5-aminolevulinic acid) will be applied to subjects' skin for either zero time incubation or one hour incubation

Blue light therapy

Intervention Type: DEVICE

Subjects will be exposed to blue light

Interventions

ALA (5-aminolevulinic acid)

ALA (5-aminolevulinic acid) will be applied to subjects' skin for either zero time incubation or one hour incubation

Intervention Type: DRUG

Blue light therapy

Subjects will be exposed to blue light

Intervention Type: DEVICE

Other Intervention Names

Levulon kerastick; BLU-U® Blue Light Photodynamic Therapy Illuminator

Eligibility Criteria

Inclusion Criteria

1. Subjects who have been diagnosed with actinic keratosis.

2. Subjects who by the investigator deem to be suitable for photodynamic therapy of the face or scalp.

3. Males or females ≥ 18 years old

4. Fitzpatrick skin types I-VI

5. Subjects are in good health as judged by the investigator.

6. Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator.

Exclusion Criteria

1. Subjects who by the investigator are not suitable for photodynamic therapy.

2. Lesions suspicious or proven for skin cancer

3. History of 2 or more ALA- PDT treatments within the past 6 months.

4. Use of keratolytics within 2 days of initiation of treatment (e.g., >5% urea, glycolic acid, lactic acid, salicyclic acid)

5. Cryotherapy within the past 2 weeks.

6. Topical retinoids within the past 4 weeks

7. Procedures, such as microdermabrasion, ablative lasers, ALA-PDT, chemical peels, 5-fluorouraci, diclofenac, imiquimod within the past 8 weeks

8. Systemic retinoids within the past 6 months

9. Pregnant or breast feeding

10. Uncooperative subjects or subjects with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.

11. Subjects who are unable to understand the protocol or give informed consent.

12. Subjects who in the opinion of the investigator are not suitable for the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Murad Alam

Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Murad Alam, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00204459

Identifier Type: -

Identifier Source: org_study_id