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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT02660320
Eligibility Criteria:
Inclusion Criteria:
* Men and women aged over 18 years old with a diagnosis of non-segmental lesions that has been stable over three months
* The minimum distance between the normal pigmented skin and the test area should preferably be at least 0.5 cm.
* For each patient the lesions are located on the same area (either chest, back, legs or arms)
* The lesion area must be: 2cm2 \< lesion\<50cm2
* Treatment resistant areas (failure of at least one medical procedure topical tacrolimus or topical steroids for 6 months).
* Absence of infected lesion
* Lesions stable for at least one year
Exclusion Criteria:
* Hypersensibility to local anaesthetics or one of the components of the device (trypsin, hyaluronic acid)
* Indication against biopsies
* Patient with a history of melanoma
* Positive serology (ongoing serious systemic disease, herpes, HIV, hepatitis B and C)
* History of keloidal scars and presence of Koebner's phenomenon (type 1 and type 2b)
* Infected lesion
* Patient with concomitant photosensitizing treatment
* Age \<18 years
* Major deprived of their freedom by administrative or legal decision, or being the subject of a legal protection measure, or out of state to express their consent
* Pregnant,delivering or lactating patients. For the women childbearing potential, a urinary pregnancy test will be done and effective contraception will be expected.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02660320
Study Brief:
Protocol Section:
NCT02660320