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OpenTrials
Completed

NCT Number: NCT06712381

Carac & PDT Combination in the Treatment Of Actinic Keratoses

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.

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Key information

Conditions

Actinic Keratoses Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluorouracil

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.

Other names: Carac

Photodynamic Therapy

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.

Carac in combination with PDT

Procedure

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Skin Laser & Surgery Specialists

Other

Collaborators

  • Sanofi

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Dec 2, 2024
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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