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

NCT00814528 | Withdrawn

• 1 other identifier: 15725A
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Actinic Keratosis

Keywords

actinic keratosis; skin lesions; 5-ALA; AK; Blu-Light

Outcome Measures

Primary Outcomes (1)

• Actinic keratosis /incomplete therapy and reoccurence

  18 months

Secondary Outcomes (1)

• Erythema

  2 weeks post therapy

Study Arms (2)

1

EXPERIMENTAL

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

Drug: 5-ALA plus Blu-Light

2

EXPERIMENTAL

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

Drug: 5-FU, Imiquimod or treatment with cryotherapy

Interventions

5-ALA plus Blu-Light DRUG

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.

1

5-FU, Imiquimod or treatment with cryotherapy DRUG

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.

2

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Diagnosied with actinic keratoses.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Fluorouracil; Imiquimod; Therapeutics; Cryotherapy

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Maria Tsoukas, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2008
• First Posted: December 25, 2008
• Study Start: November 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: September 10, 2018

Record last verified: 2018-09

Locations

US (1)