CompletedPhase 2

Everolimus for Treatment of Disfiguring Cutaneous Lesions in Neurofibromatosis1 CRAD001CUS232T

United States24 participantsStarted 2015-02

Plain-language summary

This trial is evaluating the use of oral Everolimus to determine if there is a reduction in the size of the disfiguring cutaneous lesions in patients with Neurofibromatosis 1 over a 6 month period. The evaluation will be done by 3D photography measuring volume with the LIFEVIZ Micro system.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patient is at least 18 years of age at the time of enrollment
✓. Informed consent
✓. Compliance with trial requirements (photography, lab draws, medication schedules, and study visits)
✓. Diagnosis of NF 1 and has cutaneous neurofibromas that are located in in a region amenable to photography
✓. Females of child bearing potential must not be pregnant as confirmed by a negative pregnancy test (blood beta-hCG level) prior to study enrollment and must agree to use appropriate contraceptive methods for the duration of the trial
✓. Patient must have adequate liver function as shown by, total bilirubin \</= 2.0 mg/dL, ALT and AST \</= 2.5 X ULN, INR \</= 2

What they're measuring

3D Photographic Measurement of Surface Volume of Cutaneous Neurofibroma Lesion

Timeframe: 6 months

Trial details

NCT IDNCT02332902

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-03

Results submitted2017-05-09

View on ClinicalTrials.gov More Neurofibromatosis 1 trials