NCT07931664 Evaluating Photodynamic Therapy Used to Treat Cutaneous Squamous Cell Carcinoma in Situ (isSCC) on the Face, Upper Extremities & Trunk.
| NCT ID | NCT07931664 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The Center for Clinical and Cosmetic Research |
| Condition | Cutaneous Squamous Cell Carcinoma in Situ |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-11-25 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2025-11-25 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Mark S Nestor, MD, PhD
PRINCIPAL INVESTIGATOR
Center for Clinical and Cosmetic Research
Frequently Asked Questions
Who can join the NCT07931664 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cutaneous Squamous Cell Carcinoma in Situ. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07931664 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07931664 currently recruiting?
Yes, NCT07931664 is actively recruiting participants. Contact the research team at info@centerforclinicalandcosmeticresearch.com for enrollment information.
Where is the NCT07931664 trial being conducted?
This trial is being conducted at Aventura, United States.
Who is sponsoring the NCT07931664 clinical trial?
NCT07931664 is sponsored by The Center for Clinical and Cosmetic Research. The principal investigator is Mark S Nestor, MD, PhD at Center for Clinical and Cosmetic Research. The trial plans to enroll 30 participants.