WithdrawnNot Applicable

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

0Started 2016-03

Plain-language summary

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

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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).

Timeframe: 6 weeks

Trial details

NCT IDNCT00756288

SponsorNorthwestern University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-12

View on ClinicalTrials.gov More Actinic Keratoses trials

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.