Carac & PDT Combination in the Treatment Of Actinic Keratoses

Skin Laser & Surgery Specialists60 enrolled

Overview

To demonstrate if Carac treatment after PDT treatment of actinic keratoses leads to superior clinical improvement when compared to Carac or PDT treatment alone. This will be done by manual counts and through photography.

Carac has been shown to be highly effective for the treatment of actinic keratoses. Photodynamic Therapy (PDT) has also been shown to be highly effective for the treatment of actinic keratoses. Both treatments are FDA approved. The mechanism of action of each therapy is different. In general a more vigorous, but less cosmetically acceptable appearance is seen after Carac treatment as compared to PDT treatment. The purposes of this study are to determine 1) If the use of Carac, followed by PDT treatment, of actinic keratoses leads to an enhanced clinical improvement as compared to PDT treatment alone; 2) If the cosmetic appearance of the skin during Carac is improved with PDT pre-treatment; 3) Evaluate histologic changes induced by combined Carac/PDT treatment as compared to Carac treatment alone and PDT treatment alone.;4) Evaluate safety of treatments in terms of potential for infection and scarring

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Actinic Keratoses

Interventions

FluorouracilDRUG

Carac (fluorouracil) Cream, 0.5% is used by adults to treat skin conditions on the face and front part of the scalp called solar keratosis or actinic keratosis.

Photodynamic therapyPROCEDURE

Photodynamic therapy (PDT) is a procedure that uses a photosensitizing drug to apply light therapy selectively to target pre-skin cancer, acne and sun damage.

Carac in combination with PDTPROCEDURE

Eligibility

Sex: ALLMin age: 40 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Males/females,, aged 40-70 * Must have 5 or more documented facial/anterior scalp actinic keratoses * Read, understood, and signed informed consent form * Willing and able to comply with all follow-up requirements Exclusion Criteria: * Previous treatment of facial keratoses with any modality of treatment within 3 months of study enrollment * Contraindications to the use of either Carac and/or PDT treatment * Exclusion of biopsy proven skin cancer in the area * Active infections or dermatitis in the treatment area

Outcomes

Primary Outcomes

Reduction of Actinic Keratoses

The objective of this study is to demonstrate if Carac treatment after PDT treatment of actinic keratoses leads to superior clinical improvement when compared to Carac or PDT treatment alone based on a manual lesion count.

Time frame: Outcomes are assessed at 3 months

Secondary Outcomes

Photographic Improvement of Actinic Keratoses

Time frame: Outcomes are assessed at 3 months

Data from ClinicalTrials.gov

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