A Photodynamic Therapy for Treatment of Actinic Keratoses

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00558688
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the efficacy of photodynamic therapy with 5-aminolevulinic acid and intense pulsed light vs absence of treatment for actinic keratoses.

Condition or Disease	Intervention/Treatment	Phase
Actinic Keratoses	Procedure: Photodynamic therapy	N/A

Detailed Description

This study seeks to evaluate the efficacy of photodynamic therapy with 5-aminolevulinic acid and intense pulsed light vs. absence of treatment for actinic keratoses

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Photodynamic Therapy for Treatment of Actinic Keratoses
• Study Start Date: Aug 1, 2007
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Light Therapy	Procedure: Photodynamic therapy; Photodynamic therapy applied to actinic keratoses
Experimental: 2 Light Therapy	Procedure: Photodynamic therapy; Photodynamic therapy applied to actinic keratoses

Outcome Measures

Primary Outcome Measures

1. Visual assessment of lesions [4 weeks]

Secondary Outcome Measures

1. Patient subjective assessment and Safety [4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Age greater than or equal to 18 years

• Have a t least 4 nonhypertrophic AK lesions on the body

• The subjects are in good health

• The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate to the investigator

Exclusion Criteria:

• Subjects who are pregnant or lactating

• Subjects with a history of cutaneous photosensitivity or porphyria, hypersensitivity to porphyrins, or photodermatosis

• Subjects with use of photosensitizing drugs within 1 week of study start

• Subjects with use of topical medications such as corticosteroids, alpha-hydroxyacids or retinoids 2 weeks before study entry

• Subjects with systemic steroid therapy within 4 weeks before study entry

• Subjects who received previous treatment of target AKs

• Subjects with systemic treatment with chemotherapeutic agents, masoprocol (Actinex), immunotherapy, or retinoids within 2 months of study entry

• Subjects with prior history of hypersensitivity reactions to lidocaine

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University Department of Dermatology	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

• Principal Investigator: Murad Alam, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Murad Alam, Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery, Northwestern University
• ClinicalTrials.gov Identifier: NCT00558688
• Other Study ID Numbers: STU00000312
• First Posted: Nov 15, 2007
• Last Update Posted: Dec 6, 2021
• Last Verified: Dec 1, 2021

• Additional relevant MeSH terms: Keratosis, Actinic; Keratosis

Study Results

No Results Posted as of Dec 6, 2021