Dosing and Tolerability of Deoxycholic Acid vs. Polidocanol in the Treatment of Neurofibromatosis… (NCT06120036) | Clinical Trial Compass
CompletedPhase 1
Dosing and Tolerability of Deoxycholic Acid vs. Polidocanol in the Treatment of Neurofibromatosis Type 1 Cutaneous Neurofibromas
United States20 participantsStarted 2022-12-06
Plain-language summary
This study will evaluate the tolerability and effectiveness of two treatments in Neurofibromatosis Type 1 Cutaneous Neurofibromas. These treatments are: Kybella and Asclera injection. Each patient will have a treatment and a control site.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. Adult males and females ≥18 years of age
✓. Have 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
Exclusion criteria
✕. Patients who are undergoing other treatment modalities or investigational agents for their cNF lesions
✕. Individuals who cannot give informed consent or adhere to study schedule
✕. Actively tanning during the course of the study
✕. Adverse reactions to compounds of any external agent (e.g., gels, lotions or anesthetic creams) required for use in the study, if no alternative to the said agent exists;
✕. Known allergy to injectable anesthetics, polidocanol or deoxycholic acid
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]