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)"

NCT06577311 Phase 2 RECRUITING

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 gel 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 14 visits in total and will receive a total of two treatments, after voluntarily consent has been given.

Details

Lead sponsor	The Center for Clinical and Cosmetic Research
Phase	Phase 2
Status	RECRUITING
Enrolment	20
Start date	2024-08-14
Completion	2025-08

Conditions

• Cutaneous Squamous Cell Carcinoma

Interventions

• Aminolevulinic acid hydrochloride 10% topical gel with Red Light

Primary outcomes

• Number of participants with histological clearance of treated SCCis lesion. — an average of 12 weeks
  Histological clearance is defined as the absence of detectable evidence of SCCis tumor cell nests by the central pathology reports

Countries

United States