Daylight-PDT With MAL for AK and Photodamaged Skin (NCT02736760) | Clinical Trial Compass
CompletedPhase 4
Daylight-PDT With MAL for AK and Photodamaged Skin
Germany58 participantsStarted 2016-03-03
Plain-language summary
This study is a multicenter study investigating the clinical efficacy of repetitive daylight-PDT with MAL (Methylaminolevulinate) compared to cryosurgery in regard to prophylaxis and treatment of AKs (actinic keratoses) in the face. Patients will be randomly allocated to treatment groups. 5 PDT (photodynamic therapy) treatment sessions (visits 1-5) will be performed within 18 months. In the control group, cryosurgery will be performed at visit 1, and in case of non-cleared or newly occurred AKs at visits 2-5.
In the PDT group the patients will apply a chemical sunscreen (SPF 50+) to the whole face and other light-exposed, unprotected areas of the skin. After at least 15 minutes a lesion preparation of AKs (removal of crusts) will be performed and MAL will be applied in a thin layer to the whole face. Within 30 min after MAL application patients expose themselves to daylight for 2 hours. In the control group, cryosurgery will be performed using liquid nitrogen spray in each AK lesion; this will be done at visit 1 and, if necessary, also at visits 2-5. At visits 2-6, the efficacy of the treatment will be evaluated by the observer by documenting all existing and newly appearing AKs in the face.
Who can participate
Age range
40 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:
* Written informed consent has been signed prior to or at Screening Visit
* Male and female patients with Fitzpatrick skin type I-IV
* Age \> 40 years
* Negative pregnancy test in women of childbearing age
* Women in child-bearing age using highly efficient contraceptive methods (\<1% failure rate per year)
* Clinical diagnosis of actinic keratosis (AK)
* A minimum of five non-hyperkeratotic, non-pigmented AK lesions in the face.
* Glogau Photodamage Classification Type II (moderate) - IV (severe)
Exclusion Criteria:
* Diagnosis of porphyria
* Hyperkeratotic or pigmented AK in the face
* Malignant skin tumors in the face or on the capillitium, requiring treatment
* Patients with clinically relevant suppression of the immune system (e.g. drug induced, infection) or organ transplant patients
* Pregnancy or lactation
* Planned aesthetic treatments in the face in the next 24 months (filler, peeling, botulinumtoxin, skin resurfacing)
* Known intolerance or allergy to MAL or to any other ingredient of Metvix® 160mg/g cream
* Known intolerance to Actinica® lotion
* Photosensitivity
* Suspected lack of compliance (e.g. due to dementia)
* Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding inclusion
* Concomitant UV-phototherapy
* Skin diseases that might interfere with response evaluation of study treatment
* Skin sun sensitivity type V or VI according to Fitzpatrick
* PDT in the face…
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
1
The cumulative number of observed AKs at time points 2 to 6 (3 months after the first treatment to 24 months after the first treatment).