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Carac & PDT Combination in the Treatment Of Actinic Keratoses

NCT ID: NCT06712381

Last Updated: 2024-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2011-04-30

Brief Summary

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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

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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

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Actinic Keratoses

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Carac

Group Type ACTIVE_COMPARATOR

Fluorouracil

Intervention Type DRUG

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.

2

Photodynamic Therapy

Group Type ACTIVE_COMPARATOR

Photodynamic therapy

Intervention Type PROCEDURE

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.

3

Carac combined with Photodynamic Therapy

Group Type ACTIVE_COMPARATOR

Carac in combination with PDT

Intervention Type PROCEDURE

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type PROCEDURE

Carac in combination with PDT

Intervention Type PROCEDURE

Other Intervention Names

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Carac

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Skin Laser & Surgery Specialists

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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SLSS-DG08

Identifier Type: -

Identifier Source: org_study_id