Photo-therapy With a Topical Retinoid Versus Photo-therapy Alone for Actinic Keratoses

A Randomized Controlled Paired Comparison of Photo-therapy With a Topical Retinoid Cream Pretreatment Versus PDT Alone for Actinic Keratoses

Evaluating safety and efficacy of the use of topical retinoid with photodynamic therapy for the treatment of actinic keratoses.

Evaluating safety and efficacy of the use of topical retinoid with photodynamic therapy vs photodynamic therapy alone for the treatment of actinic keratoses.

Inclusion Criteria

• Adults aged 18-80 years old
• Subjects with AK lesions who will receive PDT
• Subjects with AK lesions in two areas other than face and scalp each with a surface area of 10cm2 or greater and at least 3 clinically diagnosed non-hypertrophic AK lesions in each
• Subjects in good health
• Subjects with willingness and the ability to understand and provide informed consent

Exclusion Criteria

• Subjects who are pregnant or lactating
• Subjects with a history of cutaneous photosensitivity or porphyria, hypersensitivity to porphyrins, or photodermatosis
• Subjects with use of photosensitizing drugs within 1 week of study start
• Subjects with use of topical medications such as corticosteroids, alpha-hydroxyacids or retinoids 2 weeks before study entry
• Subjects who received previous treatment of target AKs within 4 weeks
• Subjects who are unable to understand the protocol or give informed consent