search
Back to results

Photodynamic Therapy Mediated by Topical Application of 5- ALA for the Treatment of Actinic Keratoses

Primary Purpose

Actinic Keratosis

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
5-ALA plus Blu-Light
5-FU, Imiquimod or treatment with cryotherapy
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratosis focused on measuring actinic keratosis, skin lesions, 5-ALA, AK, Blu-Light

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-95 years old
  • Diagnosied with actinic keratoses.

Exclusion Criteria:

  • Patients who have had Isotretinoin therapy less that 1 year prior to screening.
  • Patients who have an adverse reaction to light exposure (for example photo- exacerbated seizures).
  • History of porphyria

Sites / Locations

  • The University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Application of 5-ALA PDT to some lesions on skin with "Blue U" light source (417 nm).

5-FU, Imiquimod or treatment with cryotherapy to lesions on the skin.

Outcomes

Primary Outcome Measures

Actinic keratosis /incomplete therapy and reoccurence

Secondary Outcome Measures

Erythema
Early skin responses 2 weeks post therapy (erythema, scaling, post inflammatory skin changes, fine wrinkling of skin, mottled pigmentation)

Full Information

First Posted
December 23, 2008
Last Updated
September 7, 2018
Sponsor
University of Chicago
search

1. Study Identification

Unique Protocol Identification Number
NCT00814528
Brief Title
Photodynamic Therapy Mediated by Topical Application of 5- ALA for the Treatment of Actinic Keratoses
Official Title
Photodynamic Therapy Mediated by Topical Application of 5- ALA for the Treatment of Actinic Keratoses
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Withdrawn
Why Stopped
The study never started due to the Principal Investigator leaving the institution
Study Start Date
November 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare the treatment of skin growths called actinic keratoses (AK) with 5-ALA PDT, an FDA-approved treatment, versus treatment with other conventionally used FDA-approved agents such as cryotherapy, Imiquimod, or 5-fluorouracil (5-FU).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis
Keywords
actinic keratosis, skin lesions, 5-ALA, AK, Blu-Light

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Application of 5-ALA PDT to some lesions on skin with "Blue U" light source (417 nm).
Arm Title
2
Arm Type
Experimental
Arm Description
5-FU, Imiquimod or treatment with cryotherapy to lesions on the skin.
Intervention Type
Drug
Intervention Name(s)
5-ALA plus Blu-Light
Intervention Description
20% 5-ALA ampoules will be crushed and prepared for application after shaking for 3 minutes. Topical ALA will be applied liberally on skin with extra pressure on lesions. Incubation of ALA will take place for 0-3 hours. Exposure to Blue U light source (417 nm) (DUSA), will be performed for Actinic Keratosis for 15 minutes. Application of combination light sources will be performed when lesions are traced with one pass of Pulsed dye laser (595 nm) (Candela) followed by exposure to Blue U light source for 5-8 minutes pending response.
Intervention Type
Drug
Intervention Name(s)
5-FU, Imiquimod or treatment with cryotherapy
Intervention Description
Cryotherapy will be performed on lesions only every 2 week intervals. Application of Imiquimod will be done on the treated skin area 5 days weekly for 4-6 weeks. 5-FU will be once daily on the treated areas 4- 6 weeks. Responses will be monitored every 2 weeks.
Primary Outcome Measure Information:
Title
Actinic keratosis /incomplete therapy and reoccurence
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Erythema
Description
Early skin responses 2 weeks post therapy (erythema, scaling, post inflammatory skin changes, fine wrinkling of skin, mottled pigmentation)
Time Frame
2 weeks post therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-95 years old Diagnosied with actinic keratoses. Exclusion Criteria: Patients who have had Isotretinoin therapy less that 1 year prior to screening. Patients who have an adverse reaction to light exposure (for example photo- exacerbated seizures). History of porphyria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Tsoukas, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Photodynamic Therapy Mediated by Topical Application of 5- ALA for the Treatment of Actinic Keratoses

We'll reach out to this number within 24 hrs