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NOT YET RECRUITING
NCT07813533
EARLY_PHASE1

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

Sponsor: Northwestern University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

6 Years - Any

Study Type

INTERVENTIONAL

Enrollment

14

Start Date

2026-10

Completion Date

2028-12

Last Updated

2026-09-10

Healthy Volunteers

No

Conditions

Interventions

DRUG

sirolimus topical gel 0.2%

Topical sirolimus will be applied twice daily to the nevi with a maximum daily dose of 600 mg for patients 6-11 years of age and 800 mg for patients 12 years and older.

Locations (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, United States