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NCT07463378

PHASE1

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

Sponsor: Antoni Ribas

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-04

Completion Date

2027-02

Last Updated

2026-03-11

Healthy Volunteers

Yes

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.

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 able and willing to provide informed consent prior to study participation. 6. Female subjects of childbearing potential must have a negative pregnancy test at day 0. They should agree to use highly effective methods of birth control, defined as those with failure less than 1%, such as implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices (IUD's), sexual abstinence, or a vasectomized partner. Exclusion Criteria 1. Any lesion scheduled for excision that is suspicious for malignancy or has not been clinically assessed as benign by the treating dermatologist or surgeon. 2. History of abnormal wound healing, including keloid formation, hypertrophic scarring, chronic non-healing wounds, or delayed healing after prior procedures. 3. Target ulcer shows any signs of infection (only non-infected ulcers are eligible). 4. Unable to tolerate multi-layer bandages or compression garments. 5. Decompensated congestive heart failure. 6. Active soft tissue or bone infection requiring antibiotics. 7. Skin cancer on the target limb within the last 24 months. 8. Actively receiving chemotherapy and/or radiation therapy for cancer. 9. Treatment with a serine/threonine-protein kinase BRAF inhibitor, including but not limited to Zelboraf® (vemurafenib), Tafinlar® (dabrafenib), BraftoviTM (encorafenib) or Nexavar® (sorafenib), within 30 days or 5 half-lives of the drug prior to Day 0, whichever is longer. 10. Blood chemistry and complete blood count (CBC) values from the most recent laboratory assessment performed within the past 12 monsth: 1. WBC \< 1.5 x 109/L. 2. Absolute \< 0.9 x 109/L. 3. Platelet count \< 50 x 109/L. 4. Alanine aminotransferase \> 3 x upper limit of normal. 5. Aspartate aminotransferase \> 3 x upper limit of normal. 6. Serum albumin \<2.0 g/dL. 11. Current use of systemic corticosteroids \> 5 mg daily or equivalent within 4 weeks. 12. Currently pregnant or trying to become pregnant. 13. Inability or unwillingness to participate in all aspects of study protocol or as determined by the Investigator. 14. Known hypersensitivity to the ingredients of the study drug. 15. No known history of diabetis

Locations (1)

University of California, Los Angeles

Los Angeles, California, United States