Carac & PDT Combination in the Treatment Of Actinic Keratoses

Phase 1

Completed

• Conditions: Actinic Keratoses
• Interventions: Drug: Fluorouracil; Procedure: Photodynamic therapy; Procedure: Carac in combination with PDT

• Registration Number: NCT06712381
• Lead Sponsor: Skin Laser & Surgery Specialists

Brief 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

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Study First Submitted: 2016-04-19
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-12-02
• Last Update Posted: 2024-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Fluorouracil	Carac
2	Photodynamic therapy	Photodynamic Therapy
3	Carac in combination with PDT	Carac combined with Photodynamic Therapy

Primary Outcome Measures

Name	Time	Method
Reduction of Actinic Keratoses	Outcomes are assessed at 3 months	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.

Secondary Outcome Measures

Name	Time	Method
Photographic Improvement of Actinic Keratoses	Outcomes are assessed at 3 months	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 photographic improvement using the Actinic Keratosis-Field Assessment Scale.