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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00814528

Enrollment

Registered

2008-12-25

Start date

2007-11-30

Completion date

2009-09-30

Last updated

2018-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Actinic Keratosis

Keywords

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

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).

Interventions

DRUG5-ALA plus Blu-Light

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.

DRUG5-FU, Imiquimod or treatment with cryotherapy

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 95 Years

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

Design outcomes

Primary

Measure	Time frame
Actinic keratosis /incomplete therapy and reoccurence	18 months

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026