Study of LUT017 Gel to Improve Healing of Skin Wounds After Removal of Benign Lesions in Healthy Adults
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAntoni Ribas
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Subject must be ≥ 18 years of age.
Subjects must be in generally good health, with no dermatologic or systemic condition that may impair normal wound healing, as determined by the Investigator.
Lesions selected for excision must be benign, confirmed clinically by the treating dermatologist or surgeon prior to the procedure.
Disqualifiers
Any lesion scheduled for excision that is suspicious for malignancy or has not been clinically assessed as benign by the treating dermatologist or surgeon.
History of abnormal wound healing, including keloid formation, hypertrophic scarring, chronic non-healing wounds, or delayed healing after prior procedures.
Target ulcer shows any signs of infection (only non-infected ulcers are eligible).
Unable to tolerate multi-layer bandages or compression garments.
Trial design
Design model
Sequential
Treatments tested in this trial
LUT017,Topical BRAF inhibitor
DrugLUT017 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.
Treatment groups
9 Participants
are divided into 3 treatment groupsGroup A: UT017 Gel 0.03%Experimental treatment 1 intervention
Group B: LUT017 Gel 0.1%Experimental treatment 1 intervention
Group C: LUT017 Gel 0.25%Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Treatment-Emergent Adverse Events (TEAEs)
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.
Time frame
From Day 0 (study drug administration) through Day 7 follow-up visit (±2 days)Secondary outcomes
1
Investigator-Assessed Early Wound Healing Progression
Descriptive intra-subject comparison of early wound healing characteristics, including surface closure, tissue quality, and degree of re-epithelialization between LUT017-treated and placebo-treated excision sites.
Time frame
Day 7 (±2 days) after study drug administration2
Standardized Photographic Documentation of Wound Healing
Comparison of standardized clinical photographs of LUT017-treated and placebo-treated wounds to document differences in early healing progression and wound appearance.
Time frame
Day 7 (±2 days) after study drug administration3
Investigator Determination of LUT017 Re-application
Investigator assessment at Day 7 to determine whether relative healing response and clinical appropriateness support re-application of LUT017 gel to one or both wounds.
Time frame
Day 7 (±2 days) after study drug administrationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Antoni Ribas
Lead sponsor
University of California, Los Angeles
Sponsor institution
Source ClinicalTrials.gov
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