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

NCT00524485 | Terminated Results DMC

• 2 other identifiers: I 28204RPCI-I-28204
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Precancerous/Nonmalignant Condition

Keywords

actinic keratosis

Outcome Measures

Primary Outcomes (2)

• Protoporphyrin IX (PpIX) Accumulation as a Function of Skin Preparation, Aminolevulinic Acid Application Time, and Body Site

• Extent That the PpIX is Photobleached by the Treatment Light

Secondary Outcomes (5)

• Effects of Different Treatment Conditions on Acute Reactions of Actinic Keratoses (AK) and Sun Damaged Skin Occurring 24-48 Hours After Photodynamic Therapy

• Effects of Different Treatment Conditions on Efficacy

• Histological Response

• PpIX Accumulation in Incidental AK as a Function of Skin Preparation, Aminolevulinic Acid Application Time, and Body Site

• Extent That the PpIX is Photobleached by the Treatment Light in Incidental Lesions

Study Arms (5)

Arm 1 - ALA

EXPERIMENTAL

Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.

Drug: aminolevulinic acid

Arm 2

EXPERIMENTAL

Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT

Drug: aminolevulinic acid

Arm 3

EXPERIMENTAL

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

Arm 4

EXPERIMENTAL

Vbeam laser pulse (photodynamic therapy) is applied to the subunit

Procedure: laser therapy

Arm 5

EXPERIMENTAL

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

Interventions

aminolevulinic acid DRUG

Arm 1 - ALA; Arm 2; Arm 3

laser therapy PROCEDURE

Arm 4; Arm 5

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Precancerous Conditions; Keratosis, Actinic

Interventions

Aminolevulinic Acid; Laser Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Limitations and Caveats

Study was activated prior to RPCI putting a centralize data entry and data management. Data entry of the treatment arm assignments and outcomes was done by PI's staff and has since been lost. PI died, all attempts to retrieve the data have failed.

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute

716-845-2300

Study Officials

• Nathalie Zeitouni, MD,

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: August 31, 2007
• First Posted: September 3, 2007
• Study Start: May 1, 2005
• Primary Completion: January 1, 2009
• Study Completion: May 1, 2009
• Last Updated: June 14, 2017
• Results First Posted: May 17, 2017

Record last verified: 2017-05

Locations

US (1)