Study of LUT017 Gel to Improve Healing of Skin Wounds After Removal of Benign Lesions in Healthy Adults

Part of paid clinical trials in Los Angeles, California.

Sponsor
Antoni Ribas
Study ID
NCT07463378
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • LUT017,Topical BRAF inhibitor — DRUG
    LUT017 gel is a topical formulation of a small-molecule BRAF inhibitor developed to induce paradoxical activation of the MAPK pathway in BRAF wild-type keratinocytes. The gel is administered once directly to the open wound. Three concentrations (0.03%, 0.1%, and 0.25% w/w) and placebo are evaluated sequentially using a 3+3 dose-escalation design. The formulation is an aqueous-based gel containing organic solvents to optimize dermal penetration while minimizing systemic absorption. Treatment is applied in clinic by qualified investigators.

Study Details

This is a Phase 1 research study evaluating the safety and potential benefits of a topical gel called LUT017 in helping skin wounds heal after minor skin procedures. The study will enroll healthy adults who are already scheduled to have two benign (non-cancerous) skin lesions, such as moles, removed as part of routine care. When the lesions are removed, two small wounds will be created. One wound will be treated with LUT017 gel, and the other will be treated with a placebo gel that does not contain active medication. This allows each participant to serve as their own comparison. The study team will monitor how the wounds heal over approximately one week using clinical evaluation, photographs, and safety assessments. LUT017 is a topical medication designed to activate natural skin repair pathways and potentially promote faster healing. The main purpose of this study is to determine whether a single application of LUT017 gel is safe and well tolerated when applied to fresh skin wounds, and to look for early signs that it may improve or speed up wound healing compared to placebo. The primary question this study aims to answer is: Is LUT017 gel safe when applied to acute skin wounds, and does it show preliminary evidence of improving early wound healing in healthy adults? Participants will be followed for about one week after treatment, with blood tests and skin evaluations to monitor for any side effects. The information gathered from this study will help determine whether LUT017 should continue to be developed as a potential treatment to support wound healing.

Key Dates

Start date
Apr 30, 2026
Status verified
May 2026
Primary completion
Oct 31, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
9 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: UT017 Gel 0.03%
    Subjects receive a single topical application of LUT017 gel 0.03% to one acute excisional wound and placebo gel to a paired wound immediately following benign lesion removal. Safety, tolerability, pharmacokinetics, and early wound healing are assessed over 7 days.
  • Experimental: LUT017 Gel 0.1%
    Subjects receive a single topical application of LUT017 gel 0.1% to one acute excisional wound and placebo gel to a paired wound immediately following benign lesion removal. Safety, tolerability, pharmacokinetics, and early wound healing are assessed over 7 days.
  • Experimental: LUT017 Gel 0.25%
    Subjects receive a single topical application of LUT017 gel 0.25% to one acute excisional wound and placebo gel to a paired wound immediately following benign lesion removal. Safety, tolerability, pharmacokinetics, and early wound healing are assessed over 7 days.

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: From Day 0 (study drug administration) through Day 7 follow-up visit (±2 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, Los AngelesLos AngelesCalifornia90095
Ignacio Baselga, PhD
[email protected]
3102063548
Cynthia R Gonzalez
[email protected]
Antoni Ribas, MD, PhD (SUB_INVESTIGATOR)
William Zhang, MD (PRINCIPAL_INVESTIGATOR)
Amanda Truong, MD, PhD (SUB_INVESTIGATOR)
Jeremy C Davis, PhD (SUB_INVESTIGATOR)

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By research site
University of California, Los Angeles· Los Angeles, CA

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