Photodynamic Therapy Using Topical Aminolevulinic Acid in Treating Patients With Actinic Keratosis

This study has been terminated.
(Withdrawn due to low accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00524485
First received: August 31, 2007
Last updated: September 19, 2013
Last verified: September 2013
  Purpose

RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, abnormal cells are killed. Photodynamic therapy using topical aminolevulinic acid may be effective against actinic keratosis.

PURPOSE: This randomized clinical trial is studying how well different photodynamic therapy regimens using topical aminolevulinic acid work in treating patients with actinic keratosis.


Condition Intervention
Precancerous/Nonmalignant Condition
Drug: aminolevulinic acid
Procedure: laser therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study to Investigate the Use of Topical Levulan® With Vbeam® Laser for the Treatment of Actinic Keratoses

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Protoporphyrin IX (PpIX) accumulation as a function of skin preparation, aminolevulinic acid application time, and body site [ Designated as safety issue: No ]
  • Extent that the PpIX is photobleached by the treatment light [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effects of different treatment conditions on acute reactions of actinic keratoses (AK) and sun damaged skin occurring 24-48 hours after photodynamic therapy [ Designated as safety issue: No ]
  • Effects of different treatment conditions on efficacy [ Designated as safety issue: No ]
  • Histological response [ Designated as safety issue: No ]
  • PpIX accumulation in incidental AK as a function of skin preparation, aminolevulinic acid application time, and body site [ Designated as safety issue: No ]
  • Extent that the PpIX is photobleached by the treatment light in incidental lesions [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: May 2005
Study Completion Date: May 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 - ALA
Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.
Drug: aminolevulinic acid
Experimental: Arm 2
Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT
Drug: aminolevulinic acid
Experimental: Arm 3
Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment
Drug: aminolevulinic acid
Experimental: Arm 4
Vbeam laser pulse (photodynamic therapy) is applied to the subunit
Procedure: laser therapy
Experimental: Arm 5
Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart
Procedure: laser therapy

Detailed Description:

OBJECTIVES:

Primary

  • To determine, using fluorescence measurements, the protoporphyrin IX (PpIX) accumulation in thin actinic keratoses (AK) and actinically damaged skin on the face, scalp, and upper torso (stratum 1) and the PpIX accumulation in thick AK and actinically damaged skin on the arms and legs (stratum 2) as a function of skin preparation, aminolevulinic acid (ALA) application time, and body site.
  • To determine the extent that the PpIX is photobleached by the treatment light.

Secondary

  • To assess the effects of different treatment conditions on acute reactions of AK and sun damaged skin to ALA-photodynamic therapy (PDT) occurring 24-48 hours after PDT.
  • To assess the effects of different treatment conditions on the efficacy of ALA-PDT.
  • To examine the histological response to ALA-PDT.
  • To determine, using fluorescence measurements, the PpIX accumulation in incidental thick AK that may occur in stratum 1, and the PpIX accumulation in incidental thin AK that may occur in stratum 2 as a function of skin preparation, ALA application time and body site.
  • To determine the extent that the PpIX in these incidental lesions is photobleached by treatment light.

OUTLINE: The randomization is a two-step restricted block process for application time and skin preparation, followed by randomization for light dose (1 vs 2 pulses) within the anatomic site. Within each stratum (stratum 1 or 2), lesions in each separate anatomic area (face and neck, scalp, upper torso; arms, legs) are randomized to receive 1 of 3 pretreatment skin preparation before receiving topical aminolevulinic acid (ALA): pretreatment with acetone, gentle abrading, or no pretreatment. Patients are randomized to receive ALA at different times before the photodynamic therapy (PDT).

  • Arm I: Patients receive topical ALA 2 hours before PDT.
  • Arm II: Patients receive topical ALA 4 hours before PDT.
  • Arm III: Patients receive topical ALA 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment.
  • Arm IV: 1 Vbeam laser pulse (photodynamic therapy) is applied to the subunit.
  • Arm V: 2 Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart. Patients with progressive lesions or lesions that have not responded after 3 treatments may receive diagnostic biopsy to check for invasive squamous cell carcinoma and referred to treatment off study.

Patients undergo biopsies at baseline, before and after ALA application prior to light treatment, and up to 24 hours after light treatment to analyze cytokines and genes specific to actinic keratoses.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Actinic keratosis lesion located in any of the following body sites:

    • Stratum 1*: face and neck, scalp, or upper torso

      • At least 1 clinically evident thin actinic keratosis on each side of the midline of any of the above areas
    • Stratum 2*: arms or legs

      • At least 1 clinically evident thick actinic keratosis on each arm or leg NOTE: *One patient may be in one or both strata depending on the location of the lesion(s)
  • Lesions to be treated on this protocol must not have been previously treated by other modalities for at least 2 months prior to study entry

PATIENT CHARACTERISTICS:

  • No porphyria or known hypersensitivity to porphyrins
  • No known photosensitivity disease
  • No known sensitivity to any components of aminolevulinic acid topical solution
  • Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

  • Other concurrent topical therapies at lesion sites other than those used in this protocol are allowed
  • No other concurrent photosensitizer drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00524485

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Nathalie Zeitouni, MD, Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00524485     History of Changes
Other Study ID Numbers: I 28204, RPCI-I-28204
Study First Received: August 31, 2007
Last Updated: September 19, 2013
Health Authority: United States: Federal Government

Keywords provided by Roswell Park Cancer Institute:
actinic keratosis

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Precancerous Conditions
Skin Diseases
Neoplasms
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 18, 2014