drugset / Trial / NCT07813533

A Pilot Study to Examine the Efficacy and Tolerability of Sirolimus on Epidermal Nevi Lesions in Patients 6 Years Old and Above.

NCT07813533 ↗

Phase 0 Not yet recruiting 14 enrolled Northwestern University
NaSingle-groupOpen-labelTreatment

Summary

We hypothesize that topical sirolimus could suppress the mTOR activation of linear verrucous epidermal nevi, particularly when the variants are involving genes upstream of mTOR and perhaps even those of the RAS pathway through crosstalk and downstream signaling. Indeed, a recent study noted a few cases of epidermal nevi that were improved within 3-4 months by the use of topical sirolimus. We propose to perform a pilot study of epidermal nevi to observe the impact of treatment twice daily of epidermal nevi with serial photography and scoring to capture alterations during the 3 months of the study. We will also grade local tolerance to the topical gel.

Timeline

Start
2026-10
Primary completion
2028-09
Completion
2028-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Sirolimus Small molecule 600 mg Topical
Subject Sirolimus Small molecule 800 mg Topical

Indications