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
Sun Pharmaceutical Industries Limited
Summary
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.
Description
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.
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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…
Interventions
- DrugInvestigational 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 hours the treatment area will not be covered. After, the light therapy will begin and last for 8 minutes and 20 seconds. After treatment, the study staff will perform serial blood draws for PK testing at pre-determined time points during the day.
- DevicePhotodynamic 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 hours the treatment area will not be covered. After, the light therapy will begin and last for 8 minutes and 20 seconds. After treatment, the study staff will perform serial blood draws for PK testing at pre-determined time points during the day.
Location
- J&S StudiesCollege Station, Texas