Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT02736760
Eligibility Criteria:
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 during 6 months preceding study treatment
* Non-permitted medication:
* Topical treatment in the face during 4 weeks preceding study treatment with diclofenac, hydrochinone, peeling, 5-FU, ingenolmebutate, retinoids, podophyllin, azelaic acid, imiquimod or other agents, that could interfere with the evaluation of the efficacy of the study treatment, according to the investigator.
* Systemic treatment with retinoids
* Conditions that might interfere with the ability to understand the study and thus give written informed consent
* Rejuvenating treatments of the face during 3 months preceding study treatment, including filler, botulinumtoxin and IPL
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT02736760
Study Brief:
Protocol Section:
NCT02736760