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Evaluating Photodynamic Therapy Used to Treat Cutaneous Squamous Cell Carcinoma in Situ (isSCC) on the Face, Upper Extremities & Trunk.
An Investigator Initiated Study to Evaluate the Safety and Efficacy of Aminolevulinic Acid 20% Topical Solution (Levulan® Kerastick®) (ALA) With Blue Light Model 4170E in the Treatment of Cutaneous Squamous Cell Carcinoma in Situ (isSCC) Located on the Face, Upper Extremities and Trunk.
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * Must be an adult (18 years of age or older). * Voluntary written consent required. * Must have a recently diagnosed (no more than six months from first study visit) facial or trunk/ upper extremities isSCC (Squamous Cell Carcinoma in situ) lesion that meets surgery excision size requirements. * Cannot have other dermatological disease in the isSCC 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. * If female, cannot be pregnant before and during the study and agree to use acceptable forms of birth control. Exclusion Criteria: * Sensitive to any of the study treatment ingredients. * Pregnant or lactating. * Medical laboratory evidence of other non-isSCC tumor in the target lesion biopsy specimen. * History of recurrence in the target isSCC lesion. * Medical laboratory evidence of certain 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. * History of abnormal heart muscles. * Currently participating in a research study or have been treated with an investigational product within 30 days from first study treatment.
About the study
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, upper extremities and trunk, using a light sensitive cream 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 skin cancer section the treatment was able to remove, and; * seeing how many participants had no remaining affected skin cancer sections after treatment.
Participants who qualify will be asked to complete 12 visits in total and will receive a total of two treatments, after voluntarily consent has been given.
What is being tested
- Aminolevulinic Acid 20% Topical Solution with Blue Light (dose 20 J/cm2) (combination product)
- Aminolevulinic Acid 20% Topical Solution with Blue Light (dose 10 J/cm2) (combination product)
Sponsor: The Center for Clinical and Cosmetic Research · Participants: 30 · Started: Nov 25, 2025
Contact the study team
- Clinical Coordinator · Phone: 305-933-6716
Official record on ClinicalTrials.gov — NCT07931664
Locations in the U.S.
| Florida | Center for Clinical and Cosmetic Research, Aventura |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.