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Photo-therapy With a Topical Retinoid Versus Photo-therapy Alone for Actinic Keratoses

Not Applicable
Withdrawn
Conditions
Actinic Keratoses
Interventions
Procedure: Photodynamic Therapy (PDT)
Procedure: Topical retinoid and blue-light therapy with photosensitizing agent
Registration Number
NCT00756288
Lead Sponsor
Northwestern University
Brief Summary

Evaluating safety and efficacy of the use of topical retinoid with photodynamic therapy for the treatment of actinic keratoses.

Detailed Description

Evaluating safety and efficacy of the use of topical retinoid with photodynamic therapy vs photodynamic therapy alone for the treatment of actinic keratoses.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
2Photodynamic Therapy (PDT)Light therapy with photosensitizing agent
1Topical retinoid and blue-light therapy with photosensitizing agentTopical retinoid and Light therapy with photosensitizing agent
Primary Outcome Measures
NameTimeMethod
Live blinded rater and blinded photo rater analysis of areas at week 0 and week 6 for erythema, edema, crusting, ulceration, palpability, need to cease/delay treatment, and overall response in reduction of number of actinic keratoses (AKs).6 weeks
Secondary Outcome Measures
NameTimeMethod
Subjects will assess pain, burning and itching on a scale of 0-3 at week 0, during retinoid treatment, during photo-therapy, one day after, and week 6. Also, principal investigator will evaluate adverse events at week 6.6 weeks
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