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 @ 3:02 PM
Ignite Modification Date:
2025-12-24 @ 3:02 PM
NCT ID:
NCT03110159
Eligibility Criteria:
Inclusion Criteria:
* Received solid organ transplant
* 3-24 months post-transplant (any number of transplant)
* Time interval of at least 6 days duration where complications such as rejection episodes, viral infections, surgical interventions and therapies with mono or polyclonal antibodies are ruled out by the transplant team.
* No prior history of NMSC in the treatment fields
* No AK/Bowen's disease in the treatment fields within the last 3 months.
* Moderate to severe sun damage
* Be willing to forego other interventions in the treatment fields than the ones approved by the investigator that would interfere with the protocol or evaluation of the study medication
Exclusion Criteria:
* Patients with Fitzpatrick's scale skin type IV-VI
* Cutaneous photosensitivity to wavelengths of 400-450 nm, porphyria or known allergies to porphyrins
* Known sensitivity to any of the components of the Levulan® Kerastick® for Topical Solution
* Prior use of topical or systemic therapies that might interfere with the evaluation of the study medication during the study, within a 3 month washout period from the time of the screening visit
* Unable to return for follow-up visits and tests
* Any condition or situation which in the Investigator's opinion may put the subject at significant risk, could confound the study results, or could interfere significantly with the subject's participation in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03110159
Study Brief:
Protocol Section:
NCT03110159