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.
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).
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
Single group
sirolimus topical gel 0.2%
DrugTopical 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.
Improvement of nevi flattening and normalization of skin color
The extent of nevi improvement will be scored at baseline and week 12 from standardized photographs by two independent asessors with an adjudicator (if needed). The score will be defined as follows: 0 = 100% improvement 1. = 90-99% improvement 2. = 69-89% improvement 3. = 50-69% improvement 4. = 30-49% improvement 5. = 10-29% improvement 6. = 0-9% improvement 7. = worsening
Satisfaction scores of treatment
Patients (and parents/LAR) will be asked for their satisfaction of the treatment (not satisfied, satisfied, very satisfied) at week 12
Patient-reported improvement of lesion
Patients (and parents/LAR) will be asked their self-evaluation of lesion improvment from 0-5 (0= cleared, 1= almost cleared, 2= good improvement, 3= slight improvement, 4= no change, 5= worse) at baseline and week 12
Reduction in peak itch score
At least 2-point reduction in peak itch NRS score (on a scale of 0-10, 0=no itch and 10=worse itch) from baseline to week 12
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