12-week Study of NFX-179 Gel in Subjects With Epidermal Nevi (NCT05195762) | Clinical Trial Compass
WithdrawnPhase 2
12-week Study of NFX-179 Gel in Subjects With Epidermal Nevi
Stopped: Sponsored declined to proceed
United States0Started 2023-06
Plain-language summary
This study of NFX-179 is an open-label study, evaluating safety, tolerability, pharmacodynamic activity, and the clinical effect in subjects with Epidermal Nevus(ENS). NFX-179 is formulated as a gel for topical administration. NFX-179 has been shown in animal studies and in human extracts to suppress p-ERK with systemic absorption of NFX-179 following topical application to be extremely low, based on serum values observed in animal studies.
Primary objectives:
* To determine the pharmacodynamic activity of NFX-179 Gel as defined by suppression of phospho-ERK (p-ERK) levels in Target EN in treatment group after 12 weeks of once-daily (QD) application
* To determine the safety and tolerability of treatment with NFX-179 Gel 1.50% applied QD for 12 weeks.
Secondary objectives:
-Clinical effect of NFX-179 Gel 1.5% defined as the percent change in EN volume after 12 weeks of QD application
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject is at least 18 years of age
✓. Subject must provide written informed consent prior to any study procedures
✓. Subject has a Target Epidermal Nevi for treatment that:
✓. Subject is willing to have hair in the area surrounding the Target EN shaved, if necessary, to obtain photographs
✓. Subject is willing to minimize exposure of the Target EN to natural or artificial ultraviolet radiation
✓. Subject is willing to abstain from application of non-study topical prescription and over the counter medications to the Target EN during the study
✓. Subject is willing to forego treatment of the Target EN, except protocol specified therapy, during the study
✓. Female subjects who are women of childbearing potential must have a negative urine pregnancy test result and be willing to use a protocol approved, contraceptive method for the duration of the study.
Exclusion criteria
What they're measuring
1
The frequency of dermal safety and tolerability assessments including pain/burning, pruritus, erythema, edema, scabbing/crusting, and vesiculation/erosion
Timeframe: 12 weeks
2
The frequency of adverse events and serious adverse events as assessed by CTCAE v4.0
. Subject has applied any of the following topical products in the previous 30 days on or in proximity to the Target EN that, in the investigator's opinion, impairs evaluation of the Target EN or which exposes the subject to an unacceptable risk by study participation:
✕. The Target EN has ever been treated with a topical MEK inhibitor or a topical BRAF inhibitor
✕. The Subject has used any of the following systemic medications in the noted time period:
✕. Subject has a history of hypersensitivity to any of the ingredients in the study medications
✕. Subject has any know intercurrent illness or physical condition that would, in the investigator's opinion, impair evaluation of the Target EN or which exposes the subject to an unacceptable risk by study participation
✕. Subject has, in the Investigator's opinion, a clinically relevant history of liver disease, including viral hepatitis, current alcohol abuse, or cirrhosis
✕. Subject has a history of metastatic disease, or active cancer (excluding non-melanoma skin cancer, Stage I cervical cancer, ductal carcinoma in situ of the breast, or Stage 0 chronic lymphocytic lymphoma) within the previous 5 years
✕. Subject has any condition (e.g., other skin conditions or diseases, metabolic dysfunction, physical examination findings, clinical laboratory findings) or situation (e.g., vacation, scheduled surgery) that would, in the Investigator's opinion, impair evaluation of the Target EN or which exposes the subject to an unacceptable risk by study participation