LUT017 Gel for Wound Healing

IB
CR
Overseen ByCynthia R Gonzalez
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new topical gel, LUT017, to determine if it accelerates and improves healing after minor skin procedures, such as mole removal. Participants will have two small wounds created during the removal of benign skin lesions. One wound will receive LUT017 gel, while the other will receive a placebo gel (containing no active medication) for comparison. The study aims to assess the safety of LUT017 and its potential healing benefits. Ideal participants are healthy adults already scheduled for the removal of two benign skin lesions. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding how LUT017 works in people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using certain cancer treatments or high doses of corticosteroids. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Early lab studies have shown that LUT017 gel helps heal skin wounds. Researchers tested the gel in the lab before applying it to humans. So far, human studies have reported no serious side effects, but this current study is among the first to test it on people. As a Phase 1 trial, researchers primarily assess the gel's safety and its tolerability for users. Participants will have their wounds closely monitored for any signs of irritation or other side effects. This early phase demonstrates that LUT017 undergoes careful testing to ensure its safety for further use.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about LUT017 gel for wound healing because it offers a potentially faster and more targeted approach compared to standard treatments like antiseptic creams and antibiotic ointments. Unlike these traditional options, which often rely on broad-spectrum ingredients, LUT017 gel is applied directly to acute wounds with the potential to enhance early healing within just a week. Additionally, LUT017 gel is being tested in different concentrations (0.03%, 0.1%, and 0.25%), allowing researchers to fine-tune the optimal dose for maximized safety and effectiveness. This targeted, short-term application could revolutionize how quickly wounds heal after minor surgeries or lesion removals.

What evidence suggests that LUT017 gel might be an effective treatment for wound healing?

Research has shown that LUT017 gel aids skin wound healing by activating the body's natural repair processes. In studies with mice, the gel promoted new skin cell growth, resulting in faster healing. Although human studies provide limited information, early results suggest it might enhance wound healing. This trial will test various concentrations of LUT017 gel (0.03%, 0.1%, and 0.25%) to evaluate their effectiveness in enhancing the skin's natural repair, potentially accelerating healing compared to treatments without active ingredients.12367

Who Is on the Research Team?

AR

Antoni Ribas, M.D., PhD

Principal Investigator

University of California, Los Angeles

WZ

William Zhang, MD

Principal Investigator

University of California, Los Angeles

AT

Amanda Truong, MD, PhD

Principal Investigator

University of California, Los Angeles

JC

Jeremy C Davis, MD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18 or older who are having two benign (non-cancerous) skin lesions removed. Participants must not have conditions that affect wound healing, active infections, diabetes, recent skin cancer on the area, or be pregnant. They should not have a history of abnormal scarring or use certain medications.

Inclusion Criteria

Must be able and willing to provide informed consent prior to study participation
Subjects must be in generally good health, with no dermatologic or systemic condition that may impair normal wound healing, as determined by the Investigator
My skin lesions are benign and confirmed by my doctor.
See 3 more

Exclusion Criteria

I have recently been treated with a BRAF inhibitor.
I have had skin cancer on my affected limb in the past 24 months.
Blood chemistry and complete blood count values must meet specified criteria
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single topical application of LUT017 gel to one wound and placebo gel to a paired wound immediately following benign lesion removal.

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including clinical evaluations, photographs, and safety assessments.

7 days
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • LUT017

Trial Overview

The study tests LUT017 gel—a topical BRAF inhibitor—applied to one fresh wound after lesion removal, while another similar wound gets a placebo gel. Each participant receives both treatments for comparison. The main goal is to check safety and early signs of improved healing over about one week.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: UT017 Gel 0.03%Experimental Treatment1 Intervention
Group II: LUT017 Gel 0.25%Experimental Treatment1 Intervention
Group III: LUT017 Gel 0.1%Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Antoni Ribas

Lead Sponsor

Citations

Study of LUT017 Gel to Improve Healing of Skin Wounds ...

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 ...

Skin regeneration and wound healing with a topical BRAF ...

The administration LUT017 gel will regenerate cutaneous stem cells and induce keratinocyte proliferation resulting in an improvement of VLU non-healing wounds.

LUT017 Gel for Wound Healing · Info for Participants

This is a Phase 1 research study evaluating the safety and potential benefits of a topical gel called LUT017 in helping skin wounds heal ...

LUT-017 - Drug Targets, Indications, Patents

... Efficacy Study of Topically Administered LUT017 Gel for Cutaneous Wound Healing. 100 Clinical Results associated with LUT-017. Login to view more data. 100 ...

5.

clinicaltrials.ucbraid.org

clinicaltrials.ucbraid.org/wound-healing

Wound Healing clinical trials at University of California Health

This is a Phase 1 research study evaluating the safety and potential benefits of a topical gel called LUT017 in helping skin wounds heal ...

A Phase 1, Open-Label Clinical Trial to Assess the Safety ...

This research study is investigating a new topical medication called LUT017, which is being developed to help heal chronic skin wounds, ...

Lutris Pharma's Founder and Chairman of the Board ...

LUT017 harnesses this paradoxical effect in order to accelerate wound healing. In preclinical model studies of skin wounds, the topical B-Raf ...