Photodynamic Therapy Incubation Times for Actinic Keratosis

Not Applicable

Active, not recruiting

• Conditions: Actinic Keratoses
• Interventions: Drug: ALA (5-aminolevulinic acid); Device: Blue light therapy

• Registration Number: NCT03066843
• Lead Sponsor: Northwestern University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-24
• Study First Submitted QC: 2017-02-24
• Study First Posted: 2017-02-28
• Study Start: 2017-03-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-01
• Last Update Posted: 2024-02-05
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zero incubation with ALA (5-aminolevulinic acid)	ALA (5-aminolevulinic acid)	Subjects will receive zero time of incubation with ALA (5-aminolevulinic acid) before photodynamic blue light therapy.
Zero incubation with ALA (5-aminolevulinic acid)	Blue light therapy	Subjects will receive zero time of incubation with ALA (5-aminolevulinic acid) before photodynamic blue light therapy.
One hour incubation with ALA (5-aminolevulinic acid)	Blue light therapy	Subjects will receive one hour of incubation with ALA (5-aminolevulinic acid) before photodynamic blue light therapy.
One hour incubation with ALA (5-aminolevulinic acid)	ALA (5-aminolevulinic acid)	Subjects will receive one hour of incubation with ALA (5-aminolevulinic acid) before photodynamic blue light therapy.

Primary Outcome Measures

Name	Time	Method
Change in number of Actinic Keratosis (AK) lesions	Baseline and 8 Weeks	The number of AK lesions will be counted by a live, blinded assessor at baseline and at Week 8 follow-up visit.

Trial Locations

Locations (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology; 🇺🇸 Chicago, Illinois, United States