Status:
COMPLETED
DPCP to Treat Cutaneous Neurofibromas Associated With NF1
Lead Sponsor:
Nicholas Gulati
Conditions:
Cutaneous Neurofibroma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Neurofibromatosis type 1 (NF1) is the most common genetic tumor predisposition syndrome, affecting up to 1 in 2500 individuals. Cutaneous neurofibromas are benign with self-limited growth; however, tu...
Detailed Description
Each subject after consent will undergo a biopsy of one cutaneous neurofibroma prior to treatment. The participant will then undergo a sensitization treatment to "normal" skin as well as one neurofibr...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Clinically diagnosed NF1 as per the expertise of the study team.
- At least four cutaneous neurofibromas greater than 4 mm in size that are able to be biopsied.
- Age ≥ 18 years.
- Ability to understand and the willingness to sign a written informed consent.
- Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Exclusion Criteria
- Subjects may not be receiving any other investigational agents.
- Subjects taking any of the following systemic therapies within 2 weeks of enrollment: corticosteroids, immunosuppressants, and/or any other medications (systemic or topical) that may affect the outcome of the study in the opinion of the investigator.
- Subjects with any underlying diseases or dermatological conditions of the affected areas that require the use of interfering topical or systemic therapy, or that may impair immune responses such as HIV or lymphadenectomy of the axillary lymph node basin that drains the skin where DPCP is to be applied.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to DPCP, or any of the other components of the DPCP ointment formulation.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
Exclusion
Key Trial Info
Start Date :
September 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2023
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT05438290
Start Date
September 14 2022
End Date
May 17 2023
Last Update
May 6 2024
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029