NCT07813533Not yet recruitingEarly phase 1
A Pilot Study to Examine the Efficacy and Tolerability of Sirolimus on Epidermal Nevi Lesions in Patients 6 Years Old and Above.
Source: ClinicalTrials.gov · Last updated 10 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 14 (estimated)
- First submitted
- 4 Sept 2026
- Start date
- Oct 2026
- Primary completion date
- Sept 2028
- Lead sponsor
- Northwestern University
- NCT number
- NCT07813533
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 14
- From Oct 2026 to the primary completion date, Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other
- Pregnant or planning to become pregnant during the course of the study
Who the study is looking for
- 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.
Age in the registry: 6 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Northwestern University Feinberg School of Medicine, Department of Dermatology Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.