NCT06712381

Carac & PDT Combination in the Treatment Of Actinic Keratoses

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Skin Laser & Surgery Specialists · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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

Conditions

• Actinic Keratoses

Interventions

Type	Name	Description
DRUG	Fluorouracil	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.
PROCEDURE	Photodynamic therapy	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.
PROCEDURE	Carac in combination with PDT

Timeline

• Start date: 2008-08-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2024-12-02
• Last updated: 2024-12-02