Using light therapy to treat early facial skin cancer
An Investigator Initiated Study to Evaluate the Safety and Efficacy of Aminolevulinic Acid Hydrochloride Topical Gel, 10% (Ameluz ®) With RhodoLED-XL® Red Light in the Treatment of Facial Cutaneous Squamous Cell Carcinoma in Situ (SCCis)"
This study is testing if a special light therapy can safely treat early facial skin cancer by using a gel and light to see how well it works.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Center for Clinical and Cosmetic Research Academic / other |
| Locations | 1 site (Aventura, Florida) |
| Trial ID | NCT06577311 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of photodynamic therapy for treating cutaneous squamous cell carcinoma in situ on the face. Participants will receive a light-sensitive gel applied to the affected area, followed by exposure to a specific light source. The study aims to determine how much cancerous tissue is removed and the rate of complete response after treatment. Participants will undergo a total of 14 visits and two treatment sessions, with careful monitoring of their health and treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a recently diagnosed facial cutaneous squamous cell carcinoma in situ that meets specific size requirements.
Not a fit: Patients who are pregnant, have other dermatological diseases in the treatment area, or are sensitive to the treatment ingredients may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-invasive option for effectively managing early-stage facial skin cancer.
How similar studies have performed: Other studies have shown promise with photodynamic therapy for skin cancers, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Must be an adult (18 years of age or older) * Must have a recently diagnosed (no more than six months from first study visit) facial SCCis lesion that meets surgery excision size requirements * Cannot have other dermatological disease in the SCCis 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 * Voluntary written consent required * Allow photographs of the area of skin cancer being treated on the face * Agree to use acceptable forms of birth control. If female, cannot be pregnant before and during the study Exclusion Criteria: * Pregnant or lactating * Sensitive to any of the study treatment ingredients * Medical laboratory evidence of other non-SCCis tumor in the target lesion biopsy specimen * History of recurrence if the target SCCis lesion * Evidence of dermatological disease or skin condition in the treatment area * Medical laboratory evidence of 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.
Where this trial is running
Aventura, Florida
- Center for Clinical and Cosmetic Research — Aventura, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Mark S Nestor, MD, PhD — Center for Clinical and Cosmetic Research
- Study coordinator: Clinical Coordinator
- Email: info@centerforclinicalandcosmeticresearch.com
- Phone: 305-933-6716
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.