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

NCT06577311 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-08-29

No results posted yet for this study

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, 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.

Conditions

Interventions

COMBINATION_PRODUCT

Aminolevulinic acid hydrochloride 10% topical gel with Red Light

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.

Sponsors & Collaborators

  • Biofrontera Inc.

    collaborator INDUSTRY

  • The Center for Clinical and Cosmetic Research

    lead OTHER

Principal Investigators

  • Mark S Nestor, MD, PhD · Center for Clinical and Cosmetic Research

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-14
Primary Completion
2025-08-31
Completion
2025-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06577311 on ClinicalTrials.gov