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Clinical Trial Details — Status: Withdrawn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
• Status: Withdrawn
• Phase: N/A
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Actinic Keratoses
• Keratosis
• Keratosis, Actinic

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