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:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2025-12-24 @ 3:21 PM
NCT ID:
NCT03076892
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of minimum 10 previously untreated not pigmented, non-hyperkeratotic AK lesions of Grade I and II of the forehead and/or scalp (according to Olsen et Al. JAAD 1991, cf. REF 31) where other therapies are unacceptable or considered medically less appropriate with a symmetrical repartition on both side of the forehead and/or scalp. The diagnosis of AK will be determined upon clinical evaluation (i.e. visual inspection and palpation) by the investigator.
* No treatment for the AKs in the previous 30 days.
* Symmetrical areas in terms of number and severity of lesions. The axis of symmetry between the two areas will be defined by the investigator according to the distribution of lesions.
* The two areas to be treated should not be coalescing. A minimum distance of 10 mm is required between the lesions located on the 2 symmetrical areas. A minimum distance of 2 mm is required between the lesions on the same side.
* Minimum 5 lesions with similar dimensions at both symmetrical areas will be treated. If the number of lesions is \>7, only 7 lesions on each side will be considered.
Exclusion Criteria:
* Patients with porphyria.
* Patients immunosuppressed for idiopathic, disease specific or therapeutic reasons.
* Use of topical corticosteroids to lesional areas within 2 weeks before PDT.
* Patients receiving local treatment (including cryotherapy and curettage-electrocoagulation, any PDT treatment) in face / scalp area within the last 30 days.
* Patients receiving topical treatment (including imiquimod, 5-FU and diclofenac, Picato) in face / scalp area within the last 30 days.in
* Use of topical retinoids or alpha-hydroxy acids, systemic retinoids, chemotherapy or immunotherapy within 30 days of PDT.
* Pigmented AK lesion(s).
* Known allergy to Metvixia/Metvix, a similar PDT compound or excipients of the cream including arachis oil, or to peanut or soya.
* Participation in other clinical studies either currently or within the last 30 days.
* Female subjects must be of either:
* Non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or,
* Childbearing potential, provided there is a confirmed negative urine pregnancy test or blood analysis prior to study treatment, to rule out pregnancy.
* Any condition which may be associated with a risk of poor protocol compliance.
* Patients currently receiving regular ultraviolet radiation therapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03076892
Study Brief:
Protocol Section:
NCT03076892