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

Conditions

• Epidermal Nevi

Eligibility Criteria

Sex

ALL

Age

6 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• sirolimus topical gel 0.2% — DRUG
  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.

Study Details

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 Dates

First listed

Sep 10, 2026

Start date

Oct 31, 2026

Status verified

Sep 2026

Primary completion

Sep 30, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

14 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Patients 6 years of age or older with a non-inflammatory epidermal nevi

Primary Outcome Measure

Improvement of nevi flattening and normalization of skin color [ Time Frame: 12 weeks ]

Central Contacts

• Dermatology CTU
  312-503-5944
  [email protected]

Locations (1)

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