LUT017 Gel for Venous Leg Ulcers and Chronic Non-Healing Skin Wounds in Adults

Conditions

• Chronic Non-Healing Cutaneous Wounds
• VLU
• Venous Leg Ulcer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• LUT017 gel — DRUG
  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 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.

Study Details

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.

Key Dates

Start date

Oct 2, 2026

Status verified

May 2026

Primary completion

Feb 28, 2027

Completion

Jun 30, 2027

Study Design

Enrollment

18 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: LUT017 Gel 0.03% Once Weekly
  Participants receive LUT017 gel 0.03% (0.3 mg/g) applied topically once weekly for up to 8 weeks to a designated chronic venous leg ulcer or non-healing cutaneous wound. Treatment is administered in clinic following a 14-day run-in period of standardized wound care. Safety, tolerability, pharmacokinetics, and wound healing parameters are evaluated throughout treatment and follow-up.
• Experimental: LUT017 Gel 0.1% Once Weekly
  Participants receive LUT017 gel 0.1% (1.0 mg/g) applied topically once weekly for up to 8 weeks to a designated chronic venous leg ulcer or non-healing cutaneous wound. Treatment is administered in clinic following a 14-day run-in period of standardized wound care. Dose escalation proceeds according to a 3+3 design based on observed safety.
• Experimental: LUT017 Gel 0.25% Once Weekly
  Participants receive LUT017 gel 0.25% (2.5 mg/g) applied topically once weekly for up to 8 weeks to a designated chronic venous leg ulcer or non-healing cutaneous wound. Enrollment in this cohort occurs after safety review of lower dose levels under the predefined dose-escalation rules.

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: From first dose (Day 0) through Week 8 (end of treatment period) ]

Central Contacts

• Ignacio Baselga, PhD
  3102063548
  [email protected]
• Cynthia R Gonzalez
  [email protected]

Locations (1)

Find similar trials in Los Angeles, CA

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