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A Phase 1, Open-Label Clinical Trial to Assess the Safety, Tolerability, and Preliminary Efficacy Study of a Single Dose of Topically Administered LUT017 Gel for Cutaneous Wound Healing in Volunteers With Healthy Skin
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.
Details
| Lead sponsor | Antoni Ribas |
|---|---|
| Phase | Phase 1 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 9 |
| Start date | 2026-04 |
| Completion | 2027-02 |
Conditions
- Wound Healing
- Acute Skin Wounds
Interventions
- LUT017,Topical BRAF inhibitor
Primary outcomes
- Incidence of Treatment-Emergent Adverse Events (TEAEs) — From Day 0 (study drug administration) through Day 7 follow-up visit (±2 days)
Safety and tolerability of a single topical application of LUT017 gel assessed by the number and severity of treatment-emergent adverse events, including local cutaneous reactions, systemic adverse events, clinically significant laboratory abnormalities, and investigator-assessed relatedness to study drug.
Countries
United States