LUT017 Gel for Venous Leg Ulcers and Chronic Non-Healing Skin Wounds in Adults
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAntoni Ribas
About this trial
This research study is investigating a new topical medication called LUT017, which is being developed to help heal chronic skin wounds, particularly those known as venous leg ulcers (VLUs). VLUs are open sores that commonly occur on the lower legs due to poor blood flow in the veins. These wounds can be painful, slow to heal, and difficult to treat, especially in older adults and people with conditions like diabetes or obesity.
LUT017 is a gel that will be applied directly to the surface of these wounds. The goal of the study is to find out if the gel is safe and well tolerated when applied once a week for up to 8 weeks. The researchers will also look for early signs of whether the gel helps the wounds heal more quickly or completely. The gel contains a medicine that has been shown in animal studies to activate natural skin repair processes and promote cell growth, potentially speeding up the healing process.
The study will involve between 12 and 18 adult participants who have had a chronic leg wound for at least 4 weeks. All participants will go through a screening process to make sure they are eligible. If they qualify, they will first complete a two-week "run-in" phase where their wound will be treated with standard medical bandages. This phase helps ensure that only participants whose wounds are not healing with normal care are included.
If participants remain eligible after this period, they will start the treatment phase. During this phase, they will come to the clinic once a week for 8 weeks to receive the LUT017 gel treatment directly on their wound. Each visit will include a physical exam, vital signs, wound evaluation, photographs of the wound, and blood tests to monitor safety.
After the 8-week treatment period, participants will return for two follow-up visits-one at 3 months and one at 6 months after their first treatment. These visits will help the researchers understand how long any benefits of the treatment might last and monitor for any delayed side effects.
In total, participants will be involved in the study for about 6.5 months and will have approximately 12 to 14 visits to the clinic. Participation is entirely voluntary, and individuals can withdraw at any time. The research team is committed to ensuring participant safety and privacy throughout the study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects with venous leg ulcers (VLU), defined by open skin lesion of the leg as a result of venous hypertension.
Subject must be ≥ 18 years of age.
Active lower extremity ulceration (CEAP classification of C6).
Non-healing VLU ≥ 4 weeks but not greater than 24 months.
Disqualifiers
Target ulcer has exposed of tendon, muscle, or bone.
Target ulcer is of non-venous etiology.
Target ulcer has been treated with living cellular therapy within 4 weeks of the randomization.
Target ulcer shows any signs of infection (only non-infected ulcers are eligible).
Trial design
Design model
Sequential
Treatments tested in this trial
LUT017 gel
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 weekly for up to 8 weeks directly to a designated venous leg ulcer or chronic non-healing cutaneous wound. Three concentrations (0.03%, 0.1%, and 0.25% w/w) 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 following a 14-day run-in period of standardized wound care.
Treatment groups
18 Participants
are divided into 3 treatment groupsGroup A: LUT017 Gel 0.03% Once WeeklyExperimental treatment 1 intervention
Group B: LUT017 Gel 0.1% Once WeeklyExperimental treatment 1 intervention
Group C: LUT017 Gel 0.25% Once WeeklyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Number and percentage of participants experiencing treatment-emergent adverse events (AEs), including adverse drug reactions (ADRs), serious adverse events (SAEs), unexpected adverse events, AEs leading to discontinuation, and AEs leading to death. Adverse events are graded according to CTCAE criteria and assessed for relationship to study drug.
Time frame
From first dose (Day 0) through Week 8 (end of treatment period)Secondary outcomes
1
Change in Wound Area Over Time
Change from baseline in wound surface area measured by physical examination and standardized photographic documentation. Wound measurements are obtained using digital wound assessment tools and evaluated descriptively across dose cohorts.
Time frame
Baseline through Week 8, Month 3, and Month 62
Rate of Complete Re-epithelialization
Proportion of participants achieving complete wound closure, defined as full re-epithelialization without drainage or need for dressing, as determined by clinical assessment.
Time frame
Week 8, Month 3, and Month 63
Time to Complete Re-epithelialization
Time from first dose to documented complete re-epithelialization of the target wound. Time-to-event analyses will be performed descriptively using Kaplan-Meier methods.
Time frame
From Day 0 through Month 6Sponsors 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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