Evaluating the Use of Photodynamic Therapy to Treat Facial Cutaneous Squamous Cell Carcinoma in Situ (SCCis)

Launched by THE CENTER FOR CLINICAL AND COSMETIC RESEARCH · Aug 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat a specific type of skin cancer called cutaneous squamous cell carcinoma in situ (SCCis), which is an early form of cancer that develops in the upper layer of the skin on the face. The treatment involves using a light-sensitive gel combined with a special light to help eliminate the cancer cells. The main goals of the trial are to find out how effectively the treatment removes the affected skin and to see how many participants are left without any signs of cancer after treatment.

To take part in this trial, participants must be adults aged 18 or older with a recently diagnosed SCCis lesion on their face that meets certain size requirements. They should not have other skin diseases in the same area and must agree to follow specific instructions during the study. Those who qualify will attend a total of 14 visits and receive two treatments. Participants will also need to give written consent, allow photographs of the treatment area, and use acceptable forms of birth control if they are female. This trial is currently recruiting participants, and those interested should check if they meet the eligibility criteria before signing up.

Gender

ALL

Eligibility 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.