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Dosing and Tolerability of Deoxycholic Acid vs. Polidocanol in the Treatment of Neurofibromatosis Type 1 Cutaneous Neurofibromas | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Dosing and Tolerability of Deoxycholic Acid vs. Polidocanol in the Treatment of Neurofibromatosis Type 1 Cutaneous Neurofibromas

Dosing and Tolerability of Deoxycholic Acid Versus Polidocanol in the Treatment of Neurofibromatosis Type 1 Cutaneous Neurofibromas

NCT06120036•Massachusetts General Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Adult males and females ≥18 years of age
•2. Have a diagnosis of NF1 based on germline genetic testing or by meeting ≥ 2 the following criteria:
•1. Family history of NF1
•2. Six or more light brown ("cafe-au-lait") spots on the skin
•3. Presence of two or more neurofibromas of any type, or one or more plexiform neurofibromas
•4. Freckling under the arms or in the groin area
•5. Two or more pigmented, benign bumps on the eye's iris (Lisch nodules)
•6. A distinctive bony lesion: dysplasia (abnormal growth) of the sphenoid bone behind the eye, or dysplasia of long bones, often in the lower leg
•7. Tumor on the optic nerve that may interfere with vision
•3. Patients must be seeking treatment for cNF
+4 more criteria

Exclusion Criteria

•1. Patients who are undergoing other treatment modalities or investigational agents for their cNF lesions
•2. Individuals who cannot give informed consent or adhere to study schedule
•3. Actively tanning during the course of the study
•4. 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;
•5. Known allergy to injectable anesthetics, polidocanol or deoxycholic acid
•6. Those with acute thromboembolic diseases
•7. Those with bleeding abnormalities or those who are currently being treated with antiplatelet or anticoagulant therapy
•8. Those with dysphagia
•9. Women who are pregnant
•10. 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

Locations (1)

Wellman Center for Photomedicine

Boston, Massachusetts, United States

Key Dates

Start Date

December 6, 2022

Primary Completion Date

January 9, 2025

Completion Date

January 9, 2025

Last Updated

February 21, 2025

Enrollment

ACTUAL participants

Conditions

Neurofibromatosis 1

Interventions

Kybella

DRUG

Asclera

DRUG

Acceptance and Commitment Therapy for Caregivers of Children With a RASopathy: An Internal Pilot Feasibility Study and Follow-up Randomized Controlled Trial

NCT05361811

Neurofibromatosis 1Noonan Syndrome+3 more

View study

RECRUITINGPHASE1/PHASE2

Cyclin-Dependent Kinase (CDK)4/6 Inhibitor Abemaciclib for Neurofibromatosis Type I (NF1) Related Atypical Neurofibromas

NCT04750928

Neurofibromatosis 1

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Dosing and Tolerability of Deoxycholic Acid vs. Polidocanol in the Treatment of Neurofibromatosis Type 1 Cutaneous Neurofibromas

Inclusion Criteria

Exclusion Criteria

Acceptance and Commitment Therapy for Caregivers of Children With a RASopathy: An Internal Pilot Feasibility Study and Follow-up Randomized Controlled Trial

Cyclin-Dependent Kinase (CDK)4/6 Inhibitor Abemaciclib for Neurofibromatosis Type I (NF1) Related Atypical Neurofibromas

A Decentralized Clinical Trial to Promote Evidence-Based Care for Underserved Patients With Neurofibromatosis 1

Photodynamic Therapy for Benign Dermal Neurofibromas- Phase II

Assessing the Efficacy of Repeat, Monthly Treatments of Deoxycholate for NF1 Associated Cutaneous Neurofibromas (cNFs)

Efficacy and Safety of Selumetinib in Adults With NF1 Who Have Symptomatic, Inoperable Plexiform Neurofibromas