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

Part of paid clinical trials in Aventura, Florida.

Sponsor
The Center for Clinical and Cosmetic Research
Study ID
NCT06577311
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aminolevulinic acid hydrochloride 10% topical gel with Red Light — COMBINATION_PRODUCT
    Participants will have their facial Cutaneous Squamous Cell Carcinoma in situ (SCCis) prepped then treated with Aminolevulinic acid hydrochloride 10% topical gel (Ameluz ®), followed by red light therapy administered for 13 minutes and 30 seconds to deliver the total desired light dose to the SCCis lesion.

Study Details

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.

Key Dates

Start date
Aug 14, 2024
Status verified
Aug 2024
Primary completion
Aug 31, 2025
Completion
Aug 31, 2025

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Photodynamic Therapy (using Red light dose)
    20 participants will be enrolled to this arm

Primary Outcome Measure

Number of participants with histological clearance of treated SCCis lesion. [ Time Frame: an average of 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Center for Clinical and Cosmetic ResearchAventuraFlorida33180
Clinical Research Coordinator
[email protected]
305-933-6716
Mark S. Nestor, MD, PhD
[email protected]
305-933-6716
Mark S Nestor, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aventura, FL

By condition
Skin cancer
By specialty
OncologySkin cancerDermatology
By research site
Center for Clinical and Cosmetic Research· Aventura, FL

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