Sirolimus for Moles

DC
Overseen ByDermatology CTU
Age: Any Age
Sex: Any
Trial Phase: Phase < 1
Sponsor: Northwestern University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

AP

Amy Paller, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for people aged 6 and older who have epidermal nevi (a type of skin mole or lesion).

Inclusion Criteria

I am at least 6 years old and have non-inflammatory epidermal nevi.
I have a raised, dark skin lesion that is not inflamed and is at least moderate in severity.
Agree to avoid emollient use at the nevus site throughout the study
See 3 more

Exclusion Criteria

Pregnant or planning to become pregnant during the course of the study
I have used topical anti-inflammatory or keratolytic medication on my lesion in the past 4 weeks.

What Are the Treatments Tested in This Trial?

Interventions

  • Sirolimus topical gel

Trial Overview

The study tests a topical gel containing sirolimus (0.2%) applied twice daily to affected skin areas for 3 months, to see if it improves the appearance of epidermal nevi.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Patients 6 years of age or older with a non-inflammatory epidermal neviExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+