RecruitingPhase 2NCT06577311

Evaluating the Use of Photodynamic Therapy to Treat Facial Cutaneous Squamous Cell Carcinoma in Situ (SCCis)

An Investigator Initiated Study to Evaluate the Safety and Efficacy of Aminolevulinic Acid Hydrochloride Topical Gel, 10% (Ameluz ®) With RhodoLED-XL® Red Light in the Treatment of Facial Cutaneous Squamous Cell Carcinoma in Situ (SCCis)"

Sponsor

The Center for Clinical and Cosmetic Research

Enrollment

20 participants

Start Date

Aug 14, 2024

Study Type

INTERVENTIONAL

Conditions

Cutaneous Squamous Cell Carcinoma

Summary

The goal of this clinical trial is to test how safe and effective it is to treat early form of cancer cells found in the upper skin layer of the face, using a light-sensitive gel used in combination with a light source. The main questions this trial aims to answer are: * to confirm using laboratory testing, how much of the affected facial skin cancer section the treatment was able to remove, and; * seeing how many participants had no remaining affected facial skin cancer sections after treatment. Participants who qualify will be asked to complete 14 visits in total and will receive a total of two treatments, after voluntarily consent has been given.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether photodynamic therapy (PDT) — a treatment that uses light and a light-sensitive cream to destroy abnormal cells — can effectively treat squamous cell carcinoma in situ (a very early-stage skin cancer) on the face, as an alternative to surgery. **You may be eligible if...** - You are 18 years or older - You have been recently diagnosed with early-stage squamous cell skin cancer (in situ) on your face (within the last 6 months) - Your lesion meets the size requirements for standard surgical removal - You are willing to follow all study instructions, including not applying unapproved lotions on treated areas **You may NOT be eligible if...** - You have other skin conditions in the treatment area - You are unable or unwilling to follow the study protocol - You have had prior treatment for this lesion Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTAminolevulinic acid hydrochloride 10% topical gel with Red Light

Participants will have their facial Cutaneous Squamous Cell Carcinoma in situ (SCCis) prepped then treated with Aminolevulinic acid hydrochloride 10% topical gel (Ameluz ®), followed by red light therapy administered for 13 minutes and 30 seconds to deliver the total desired light dose to the SCCis lesion.