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NCT00756288 Clinical Trial

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

Actinic Keratoses Clinical Trial

Official title:
A Randomized Controlled Paired Comparison of Photo-therapy With a Topical Retinoid Cream Pretreatment Versus PDT Alone for Actinic Keratoses

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00756288
Other study ID # STU2574
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date March 2016
Est. completion date December 2017

Study information
Verified date December 2021
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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 information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria - Adults aged 18-80 years old - Subjects with AK lesions who will receive PDT - Subjects with AK lesions in two areas other than face and scalp each with a surface area of 10cm2 or greater and at least 3 clinically diagnosed non-hypertrophic AK lesions in each - Subjects in good health - Subjects with willingness and the ability to understand and provide informed consent Exclusion Criteria - Subjects who are pregnant or lactating - Subjects with a history of cutaneous photosensitivity or porphyria, hypersensitivity to porphyrins, or photodermatosis - Subjects with use of photosensitizing drugs within 1 week of study start - Subjects with use of topical medications such as corticosteroids, alpha-hydroxyacids or retinoids 2 weeks before study entry - Subjects who received previous treatment of target AKs within 4 weeks - Subjects who are unable to understand the protocol or give informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Topical retinoid and blue-light therapy with photosensitizing agent
Topical Retinoid - Apply to AKs for 4 weeks Photo-therapy with photosensitizing agent- Apply to AKs at week 4
• Photodynamic Therapy (PDT)
Photo-therapy with sensitizing agent - apply to AKs at week 4

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Northwestern University

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
See also
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