An Open-Label, Two-Cohort, Pharmacokinetic Study in a Maximal Use Setting for Patients With Actinic Keratosis on the Upper Extremities or the Face

Официальное название

An Open-Label, Single-Period, Pharmacokinetic Study of Aminolevulinic Acid (ALA) and Protoporphyrin IX (PpIX) When Reformulated Levulan Kerastick is Applied Topically in A Maximal Use Setting in Separate Cohorts of Patients With Actinic Keratosis on the Upper Extremities or Actinic Keratosis on the Face

Обзор

The research study will evaluate how the body absorbs and reacts to reformulated Levulan Kerastick when applied to actinic keratosis lesions (AKs) on the skin of the forearms or face followed by photodynamic therapy (PDT), a treatment that uses application of blue light.

Подробное описание

This is a pharmacokinetic (PK) study which involves measuring drug levels in blood. Blood levels of Levulan Kerastick's active ingredient (aminolaevulinic acid, ALA) and its by-product (protoporphyrin IX, PpIX) will be measured. PK blood samples will be collected at: pre-application, 15 minutes, 0.5 hours, 1 hour, 2 hours, 3 hours, 3.5 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, and 16 hours after dose on Day 1; at 24 hours and 36 hours post-dose on Day 2; and at 48 hours post-dose on Day 3.

Вмешательства

• Препарат Investigational drug
  The study drug will be applied to the treatment area containing an acceptable number of AK lesions. If enrolled in group A (Cohort A), the treatment area will be on both forearms. During an incubation period of 3 hours the treatment area on both forearms will be covered. After the dressing will be removed, and the light therapy will begin and last for 8 minutes and 20 seconds. If you are enrolled in group B (Cohort B), the treatment area will be on the face. During the incubation period of 3 h
• Устройство Photodynamic therapy
  The study drug will be applied to the treatment area containing an acceptable number of AK lesions. If enrolled in group A (Cohort A), the treatment area will be on both forearms. During an incubation period of 3 hours the treatment area on both forearms will be covered. After the dressing will be removed, and the light therapy will begin and last for 8 minutes and 20 seconds. If you are enrolled in group B (Cohort B), the treatment area will be on the face. During the incubation period of 3 hou

Первичные конечные точки

• Plasma concentrations [Срок оценки: From treatment to 48 hours]

Вторичные конечные точки (1)

• Safety/Tolerability [Срок оценки: From treatment to Day 29]

Критерии участия

Критерии включения

• Provided written Informed Consent.
• Patient is willing and able to comply with study protocol, visit schedule, and other study-related instructions/procedures, including in-clinic stay as required.
• Patient is a male or non-pregnant female 18 to 85 years of age (inclusive) at Screening.
• Patient has either 4 or more AK lesions on the upper extremities; or 6 or more AK lesions on the face. Lesions must be within an area of 25 cm2.
• Patient is in good general health and free of any disease state or physical condition.
• Patient has veins suitable for repeat blood draws.
• Patient is willing to abstain from sunbathing, solarium use, exposure to artificial tanning devices.
• Patient is willing to follow a consistent skin care routine without significant change.
• Patient is willing to stop using all topical products within the Treatment Area(s) starting from 8 hours prior to initiation of treatment.
• Patients who are women of childbearing potential must agree to use a highly effective method of contraception during the study.
• Patients who are male with female partners of childbearing potential must use a barrier method of contraception (e.g., condom) if not surgically sterile.
• Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test before initiation of treatment at Baseline.

Критерии исключения

• Patient is pregnant, lactating, or is planning to become pregnant during the study.
• Patient has severe AK lesions within the Treatment Area.
• Patient has untreated skin cancers or lesions suspicious for skin cancer within the Treatment Area.
• Patient has an active herpes simplex infection OR a history of ≥2 outbreaks within past 12 months in the Treatment Area.
• Patient has significant skin abnormality involving the Treatment Area
• Patient has a history of skin sensitivity to light.
• Patient has known hypersensitivity to one or more components of the IP.
• Patient has a history of lead poisoning or a history of significant exposure to lead.
• Patient smokes more than 10 cigarettes/day.
• Patient has a suppressed immune system.
• Patient has a coagulation defects.
• Patient has a Body Mass Index (BMI) > 32.0 kg/m2.
• Patient has donate blood recently.
• Patient is positive for HIV, Hepatitis B and/or Hepatitis C.
• Patient has history of alcohol or drug abuse during the past year prior.
• Patient has a positive urine screen for drugs of abuse.
• Patient has abnormal labs at Screening.
• Patient had a major surgery within 30 days or plans to have surgery during the study.
• Patient has any condition which would make it unsafe for the patient to participate in this research study or interferes with assessment/interpretation of study outcomes.
• Patient received any topical or systemic therapies on the Treatment Area within a certain amount of time.
• Patient is currently enrolled in an investigational drug, investigational biologic, or investigational device study.
• Patient has received an investigational drug, investigational biologic, or investigational device treatment within 30 days or 5 half-lives of the experimental agent, whichever is longer, prior to initiation of treatment at Baseline.

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

• J&S Studies — College Station

Идентификаторы

NCT: NCT07729579 · LEVU-24-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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