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
Antoni Ribas
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.
Description
Study Overview and Clinical Context This is a Phase 1, open-label, ascending-dose clinical study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary biological activity of LUT017 gel when applied topically to acute, procedure-generated cutaneous wounds in healthy adult subjects. The study represents the first clinical investigation of LUT017 in the setting of acute wound healing in normal skin and is intended to establish an initial safety profile, characterize systemic exposure following single-dose topical administration, and inform dose selection for future con…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria 1. Subjects scheduled to undergo excision of two or more clinically benign skin lesions (e.g., melanocytic nevi or seborrheic keratoses) that will result in at least two comparable acute cutaneous wounds suitable for study treatment. 2. Subject must be ≥ 18 years of age. 3. Subjects must be in generally good health, with no dermatologic or systemic condition that may impair normal wound healing, as determined by the Investigator. 4. Lesions selected for excision must be benign, confirmed clinically by the treating dermatologist or surgeon prior to the procedure. 5. Must be…
Interventions
- DrugLUT017,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.
Location
- University of California, Los AngelesLos Angeles, California