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

NCT07463378 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-05-29

No results posted yet for this study

Summary

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.

Conditions

  • Wound Healing
  • Acute Skin Wounds

Interventions

DRUG

LUT017,Topical BRAF inhibitor

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.

Sponsors & Collaborators

  • Antoni Ribas

    lead OTHER

Principal Investigators

  • Antoni Ribas, M.D., PhD · University of California, Los Angeles

  • William Zhang, MD · University of California, Los Angeles

  • Amanda Truong, MD, PhD · University of California, Los Angeles

  • Jeremy C Davis, MD · University of California, Los Angeles

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2026-10-31
Completion
2027-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07463378 on ClinicalTrials.gov