Controlled Study of the Occurrence of Actinic Keratosis on the Face After Cryotherapy + Aminolevulinic Acid (ALA) Photodynamic Therapy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-09-30

Brief Summary

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The purpose of this study is to determine if Levulan photodynamic therapy (PDT) is safe and effective in the treatment of actinic keratoses (AK) on the face, following treatment with liquid nitrogen cryotherapy.

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Detailed Description

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Conditions

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Actinic Keratosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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ALA X3

Cryotherapy followed by 3 aminolevulinic acid + blue light (BLU-U) treatments

Group Type EXPERIMENTAL

Aminolevulinic Acid

Intervention Type DRUG

20% ALA applied to face for one hour prior to 10 J/cm2 blue light

BLU-U

Intervention Type DEVICE

10 J/cm2 blue light delivered at 10 mW/cm2

Cryotherapy

Intervention Type PROCEDURE

Liquid nitrogen cryotherapy by standard of care method to all visible/palpable actinic keratosis (AK) lesions at screening.

VEH

Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.

Group Type PLACEBO_COMPARATOR

Topical Solution Vehicle

Intervention Type DRUG

Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face one hour prior to 10 J/cm2 blue light

BLU-U

Intervention Type DEVICE

10 J/cm2 blue light delivered at 10 mW/cm2

Cryotherapy

Intervention Type PROCEDURE

Liquid nitrogen cryotherapy by standard of care method to all visible/palpable actinic keratosis (AK) lesions at screening.

ALA X2

Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments

Group Type EXPERIMENTAL

Aminolevulinic Acid

Intervention Type DRUG

20% ALA applied to face for one hour prior to 10 J/cm2 blue light

BLU-U

Intervention Type DEVICE

10 J/cm2 blue light delivered at 10 mW/cm2

Cryotherapy

Intervention Type PROCEDURE

Liquid nitrogen cryotherapy by standard of care method to all visible/palpable actinic keratosis (AK) lesions at screening.

Interventions

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Aminolevulinic Acid

20% ALA applied to face for one hour prior to 10 J/cm2 blue light

Intervention Type DRUG

Topical Solution Vehicle

Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face one hour prior to 10 J/cm2 blue light

Intervention Type DRUG

BLU-U

10 J/cm2 blue light delivered at 10 mW/cm2

Intervention Type DEVICE

Cryotherapy

Liquid nitrogen cryotherapy by standard of care method to all visible/palpable actinic keratosis (AK) lesions at screening.

Intervention Type PROCEDURE

Other Intervention Names

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Levulan Kerastick ALA BLU-U Blue Light Photodynamic Therapy Illuminator Liquid Nitrogen

Eligibility Criteria

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Inclusion Criteria

* Four to fifteen AKs on the face
* histologically confirmed presence of abnormal architecture and satellite atypical keratinocytes in the epidermis, in clinically normal tissue samples of photodamaged skin adjacent to AKs
* at least one previously treated nonmelanoma skin cancer (NMSC) on the head and/or neck area within the past five years

Exclusion Criteria

* Pregnancy
* history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
* lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area
* skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
* Subject is immunosuppressed
* unsuccessful outcome from previous ALA-PDT therapy
* currently enrolled in an investigational drug or device study
* has received an investigational drug or been treated with an investigational device within 30 days prior to the initiation of treatment
* known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol)
* has an active herpes simplex infection OR a history of 2 or more outbreaks within the past 12 months, on the face
* use of the following topical preparations on the extremity to be treated:

* Keratolytics including urea (greater than 5%), alpha hydroxyacids \[e.g.glycolic acid, lactic acid, etc. greater than 5%\], salicylic acid (greater than 2%) within 2 days
* Retinoids, including tazarotene, adapalene, tretinoin, within 4 weeks
* Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-fluorouracil (5-FU), diclofenac, ingenol mebutate, imiquimod or other topical treatments for AK within 8 weeks
* use of systemic retinoid therapy within 6 months

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No