What side effects are associated with this type of intervention?

Common treatments for acneiform lesions, particularly those induced by EGFR inhibitors, include topical therapies such as LUT014 Gel. Known side effects of these treatments can include skin irritation, dryness, and redness. In some cases, patients may experience pruritus (itchiness) at the application site. Other potential adverse effects noted in similar treatments include acne exacerbation and, less frequently, upper respiratory infections and headache. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several topical treatments for acneiform lesions, particularly those induced by EGFR inhibitors. Clindamycin phosphate and benzoyl peroxide gel is one such combination that has been shown to be effective and safe for treating cetuximab-associated acneiform eruptions. Additionally, Vitamin K1 ointment has been studied for its efficacy in treating acneiform eruptions induced by EGFR inhibitors, although it did not show statistically significant results. These treatments aim to reduce inflammation and bacterial growth, similar to the mechanism being studied in the trial for LUT014 Gel.

What other types of research exist?

Promising novel alternatives to LUT014 Gel for the treatment of EGFRI-induced acneiform lesions include: 1) Topical imiquimod, which has shown efficacy in various dermatological conditions but may have side effects such as local inflammation. 2) Photodynamic therapy (PDT) using aminolevulinic acid or methyl aminolevulinate, which has been effective in treating actinic keratoses and other skin conditions with minimal pain and good tolerability. 3) Sinecatechins, a topical treatment derived from green tea extracts, which has demonstrated immune-modulating effects and efficacy in treating external genital and perianal warts, suggesting potential for other dermatological uses.

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Topical Gel for Acne-like Skin Issues from Cancer Treatment

Phase 2

Recruiting

Research Sponsored by Lutris Pharma Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Currently being treated with an FDA approved monoclonal antibody EGFRI for the treatment of mCRC, including but not limited to Erbitux® (cetuximab) Injection and Vectibix® (panitumumab) Injection, as directed by the approved labeling

Diagnosed with mCRC

Must not have

Significant skin disease other than EGFRI induced acneiform lesions within the same body areas planned for study drug application

Has a beard that would interfere with administration of study drug and assessment of study endpoints (scoring of lesions)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks (56 days)

Awards & highlights

Summary

This trial tests a special gel applied regularly for a few weeks to help cancer patients with specific skin rashes from their treatment. The gel aims to reduce and soothe these rashes.

Who is the study for?

This trial is for adults with metastatic colorectal cancer (mCRC) who are currently being treated with certain FDA-approved EGFRI drugs and have developed Grade 2 or non-infected Grade 3 acneiform lesions. Participants should be able to apply the gel themselves or have someone to help, not have other cancers within the last three years, and women must test negative for pregnancy.

What is being tested?

The study tests two different doses of LUT014 Gel against a placebo in mCRC patients with specific skin lesions from EGFRI treatment. The gels are applied daily for four weeks to see if they reduce these skin issues better than a placebo.

What are the potential side effects?

While the trial information provided does not specify side effects, typical side effects of topical treatments may include skin irritation, redness, itching, dryness at the application site. Patients will be monitored for any adverse reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently receiving an FDA-approved monoclonal antibody treatment for my colorectal cancer.

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I have been diagnosed with metastatic colorectal cancer.

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I can take care of myself and am up and about more than half of my waking hours.

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I have moderate to severe acne that is not infected.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I don't have major skin conditions except for acne-like rashes from cancer treatment.

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I do not have a beard that would interfere with the study.

Select...

I haven't had any cancer other than colorectal in the past 3 years, except for early-stage cervical cancer.

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I do not have any serious health issues that could interfere with the study.

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I have not taken B-Raf inhibitors or certain cancer drugs in the last 30 days or 5 half-lives of the drug.

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I haven't used any topical medication on my face, neck, or chest in the last 7 days.

Select...

I haven't taken any EGFRI treatments for my colorectal cancer except the FDA-approved one within the last 30 days or 5 half-lives of the drug.

Select...

I am currently on antibiotics for an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks (56 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks (56 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks (56 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The proportion of subjects in each treatment group who reached treatment success

Secondary study objectives

Relative change in the FACT-EGFRI-18 HRQoL questionnaire

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: LUT014 Gel (Dose 2)Experimental Treatment1 Intervention

Group II: LUT014 Gel (Dose 1)Experimental Treatment1 Intervention

Group III: PlaceboPlacebo Group1 Intervention

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Topical treatments for acneiform lesions, such as LUT014 Gel, typically work by targeting inflammation, bacterial growth, and abnormal keratinization. These treatments often contain active ingredients like antibiotics, retinoids, or anti-inflammatory agents that reduce the proliferation of acne-causing bacteria, decrease inflammation, and normalize skin cell turnover. For patients with EGFRI-induced acneiform lesions, these mechanisms are crucial as they help manage the side effects of cancer treatments, improving skin appearance and patient comfort.

Randomized, Double-Blind, Placebo-Controlled Phase Ⅱ Study on the Efficacy and Safety of Vitamin K1 Ointment for Cetuximab or Panitumumab-Induced Acneiform Eruptions-VIKTORIA Study.Use of topical rapamycin in the treatment of superficial lymphatic malformations.