Carac & PDT Combination in the Treatment Of Actinic Keratoses

Skin Laser & Surgery Specialists

Status and phase: Completed; Phase 2; Phase 1

Conditions: Actinic Keratoses

Treatments: Procedure: Carac in combination with PDT; Procedure: Photodynamic therapy; Drug: Fluorouracil

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06712381

SLSS-DG08

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

1

Active Comparator group

Description:

Carac

Treatment:

Drug: Fluorouracil

2

Active Comparator group

Description:

Photodynamic Therapy

Treatment:

Procedure: Photodynamic therapy

3

Active Comparator group

Description:

Carac combined with Photodynamic Therapy

Treatment:

Procedure: Carac in combination with PDT