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

NCT07729579 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-07-27

No results posted yet for this study

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.

Conditions

  • Actinic Keratosis (AK)

Interventions

DRUG

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 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.

DEVICE

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 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.

Sponsors & Collaborators

  • Sun Pharmaceutical Industries Limited

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-04
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07729579 on ClinicalTrials.gov