Clinical trial · Interventional
Evaluating the Use of Photodynamic Therapy to Treat Facial Cutaneous Squamous Cell Carcinoma in Situ (isSCC)
An Investigator Initiated Study to Evaluate the Safety and Efficacy of Aminolevulinic Acid 20% Topical Solution (Levulan® Kerastick®) (ALA) + Blue Light in the Treatment of Facial Cutaneous Squamous Cell Carcinoma in Situ (isSCC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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, 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 facial skin cancer section the treatment was able to remove, and; * seeing how many participants had no remaining affected facial 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Facial Cutaneous Squamous Cell Carcinoma in Situ | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aminolevulinic Acid 20% Topical Solution with Blue Light | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Photodynamic Therapy (Blue light dose 10 J/cm2 at 10 mW/cm2)
- description
- 30 participants will be enrolled to this arm
- interventionNames
- Combination Product: Aminolevulinic Acid 20% Topical Solution with Blue Light
Primary outcomes (1)
- measure
- Number of participants with Histological Clearance of treated isSCC lesion
- timeFrame
- Up to 16 weeks
- description
- Histological clearance is defined as the absence of detectable evidence of isSCC tumor cell nests by the central pathology reports
Secondary outcomes (2)
- measure
- Number of participants with clinical clearance of treated isSCC lesion
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 isSCC 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
References
Publications (0)
Data not yet available