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

Официальное название

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)"

Обзор

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.

Подробное описание

In the study, participants will be asked to complete the following:

* Provide basic personal information (including date of birth, gender, race and ethnicity) * Provide their medical/ surgical history and perform a medical exam (including but not limited to symptom-directed physical exam, skin type, vital signs, height, weight and urine pregnancy test collection) * Follow study rules such as avoiding certain medications and treatments * Provide information on any medications, treatments or reactions that started after the study began * Allow two treatments on the skin cancer area of the face using a light-sensitive cream used in combination with a light source * Allow clinical documentation of the treatment, such as how well the treatment was tolerated, any skin reaction or side effects * Allow surgery to remove the skin cancer area from the face for Laboratory testing

To qualify for this trial, participants must:

* be an adult (18 years of age or older) * give voluntary written consent * have a recently diagnosed (less than six months from first visit) skin cancer area on the face that meets surgery size requirements * be willing to follow study instructions and complete study requirements, including not using non-approved lotions and creams on the treatments areas * allow photographs of the area of skin cancer being treated on the face * (if female) not be pregnant before and during the study and agree to use acceptable forms of birth control * confirm they are not sensitive to any of the study treatment ingredients

All surgery samples collected from the participants towards the end of the study will be sent to a laboratory for testing. All photographs of the treatment area collected during the study will be used as study data.

All participants have the right to refuse further participation in the study at any time.

Вмешательства

• Комбинированный продукт Aminolevulinic 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.

Первичные конечные точки

• Number of participants with histological clearance of treated SCCis lesion. [Срок оценки: an average of 12 weeks]

Вторичные конечные точки (3)

• Number of participants with clinical clearance of treated SCCis lesion [Срок оценки: an average of 12 weeks]
• Size of the lesion [Срок оценки: Up to 16 weeks]
• Local Skin Response Scale [Срок оценки: Up to 16 weeks]

Критерии участия

Критерии включения

• Must be an adult (18 years of age or older)
• Must have a recently diagnosed (no more than six months from first study visit) facial SCCis lesion that meets surgery excision size requirements
• Cannot have other dermatological disease in the SCCis target area
• Must be willing to follow study instructions and complete study requirements, including not using non-approved lotions and creams on the treatments areas
• Voluntary written consent required
• Allow photographs of the area of skin cancer being treated on the face
• Agree to use acceptable forms of birth control. If female, cannot be pregnant before and during the study

Критерии исключения

• Pregnant or lactating
• Sensitive to any of the study treatment ingredients
• Medical laboratory evidence of other non-SCCis tumor in the target lesion biopsy specimen
• History of recurrence if the target SCCis lesion
• Evidence of dermatological disease or skin condition in the treatment area
• Medical laboratory evidence of growth patterns in the target lesion biopsy specimen
• Chronic medical condition that in the Investigators opinion will interfere in the trial or affect participant safety.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Center for Clinical and Cosmetic Research — Aventura

Идентификаторы

NCT: NCT06577311 · CCCR 01-2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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