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 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT06300502
Eligibility Criteria:
Inclusion Criteria:
1. Participant is an adult ≥18 years of age.
2. Participant has a diagnosis of NF1 based on germline genetic testing or by meeting ≥ 2 the following criteria:
* Family history of NF1,
* Six or more light brown ("cafe-au-lait") spots on the skin,
* Presence of two or more neurofibromas of any type, or one or more plexiform neurofibromas,
* Freckling under the arms or in the groin area,
* Two or more pigmented, benign bumps on the eye's iris (Lisch nodules),
* A distinctive bony lesion: dysplasia (abnormal growth) of the sphenoid bone behind the eye, or dysplasia of long bones, often in the lower leg,
* Tumor on the optic nerve that may interfere with vision.
3. Participant is seeking treatment for cNF.
4. Participant has ≥ 6 paired cNF that are visible and measure 2 mm or more in size. The target treatment area must be amenable to both deoxycholate injections and surveillance with digital and 3D photography. Preferred locations are trunk (back or chest), arms and legs.
5. Participant is able and willing to comply with all visit, treatment and evaluation schedules and requirements.
6. Participant is able to understand and provide written informed consent.
7. Participant has no known allergy to deoxycholate.
8. Participant has no concurrent injury or wound in the target area.
Exclusion Criteria:
1. Participant cannot give informed consent or adhere to study schedule.
2. Participant is actively tanning during the course of the study.
3. Participant has a known allergy to deoxycholic acid.
4. For female participants: those who are pregnant.
5. Participant has any condition which, in the Investigator's opinion, would make it unsafe (for the participant or study personnel) to treat the participant as part of this research study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT06300502
Study Brief:
Protocol Section:
NCT06300502