Pharmacokinetic test of reformulated Levulan Kerastick for actinic keratosis on forearms or face

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, phase 1 pharmacokinetic study measures blood levels of aminolevulinic acid (ALA) and its by-product protoporphyrin IX (PpIX) after applying reformulated Levulan Kerastick to AK lesions on the forearms or face, prior to photodynamic therapy. Blood samples are collected at multiple time points over three days to map absorption and exposure. Participants must have suitable AK lesion burden, be in good health, and comply with treatment and sun/skin-care restrictions. The study is sponsored by Sun Pharmaceutical Industries and conducted at J&S Studies in College Station, Texas, with no listed collaborators.

Why it matters

Who can join: the full rules

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.
* 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.

Exclusion Criteria:

* 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.

Where it's running

• J&S Studies
  College Station, Texas, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.