Carac & PDT Combination in the Treatment Of Actinic Keratoses

November 26, 2024 updated by: Skin Laser & Surgery Specialists
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Carac
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.
Other Names:
  • Carac
Active Comparator: 2
Photodynamic Therapy
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.
Active Comparator: 3
Carac combined with Photodynamic Therapy
Procedure: Carac in combination with PDT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of Actinic Keratoses
Time Frame: 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.
Outcomes are assessed at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Photographic Improvement of Actinic Keratoses
Time Frame: 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.
Outcomes are assessed at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Skin Laser & Surgery Specialists

Collaborators

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

April 19, 2016

First Submitted That Met QC Criteria

November 26, 2024

First Posted (Estimated)

December 2, 2024

Study Record Updates

Last Update Posted (Estimated)

December 2, 2024

Last Update Submitted That Met QC Criteria

November 26, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLSS-DG08

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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