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

NCT07813533

Not Yet RecruitingEARLY_Phase 1

Sponsor: Northwestern University

Conditions: Epidermal Nevi

Interventions: sirolimus topical gel 0.2%

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 6 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Patients 6 years of age or above with a non-inflammatory epidermal nevi
* Lesion(s) that have been present for at least 3 years and are relatively stable
* At least 2 cm in length (ideally continuous, but can be cumulatively)
* The lesions is raised, hyperpigmented compared to the surrounding skin, and is noninflammatory with a physician global assessment (PGA) of at least 3 (moderate).
* Agree to avoid emollient use at the nevus site throughout the study
* Agree to not bath or shower 2 hours post-application, knowing that the gel can be applied after bathing or showering.

Exclusion Criteria:

* Patients currently or recently (within past 4 weeks) using a topical keratolytic or topical anti-inflammatory medication at the lesional site (i.e. topical steroid, topical retinoid, alpha-OH acid)
* Pregnant or planning to become pregnant during the course of the study

Locations (1)

Chicago, Illinois, United States