Carac & PDT Combination in the Treatment Of Actinic Keratoses

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 see...

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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
1FluorouracilCarac
2Photodynamic therapyPhotodynamic Therapy
3Carac in combination with PDTCarac combined with Photodynamic Therapy
Primary Outcome Measures
NameTimeMethod
Reduction of Actinic KeratosesOutcomes 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
NameTimeMethod
Photographic Improvement of Actinic KeratosesOutcomes 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.

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