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

August 27, 2024 updated by: Mark Steven Nestor, M.D., Ph.D., The Center for Clinical and Cosmetic Research

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)"

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In the study, participants will be asked to complete the following:

  • Provide basic personal information (including date of birth, gender, race and ethnicity)
  • Provide their medical/ surgical history and perform a medical exam (including but not limited to symptom-directed physical exam, skin type, vital signs, height, weight and urine pregnancy test collection)
  • Follow study rules such as avoiding certain medications and treatments
  • Provide information on any medications, treatments or reactions that started after the study began
  • Allow two treatments on the skin cancer area of the face using a light-sensitive cream used in combination with a light source
  • Allow clinical documentation of the treatment, such as how well the treatment was tolerated, any skin reaction or side effects
  • Allow surgery to remove the skin cancer area from the face for Laboratory testing

To qualify for this trial, participants must:

  • be an adult (18 years of age or older)
  • give voluntary written consent
  • have a recently diagnosed (less than six months from first visit) skin cancer area on the face that meets surgery size requirements
  • be willing to follow study instructions and complete study requirements, including not using non-approved lotions and creams on the treatments areas
  • allow photographs of the area of skin cancer being treated on the face
  • (if female) not be pregnant before and during the study and agree to use acceptable forms of birth control
  • confirm they are not sensitive to any of the study treatment ingredients

All surgery samples collected from the participants towards the end of the study will be sent to a laboratory for testing. All photographs of the treatment area collected during the study will be used as study data.

All participants have the right to refuse further participation in the study at any time.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Photodynamic Therapy (using Red light dose)
20 participants will be enrolled to this arm
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.
Other Names:
  • Ameluz ®
  • RhodoLED-XL®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with histological clearance of treated SCCis lesion.
Time Frame: 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
an average of 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with clinical clearance of treated SCCis lesion
Time Frame: an average of 12 weeks
Complete Clinical Clearance will be measured by the Investigator and is defined as when there is no clinically visible lesion remaining at the site
an average of 12 weeks
Size of the lesion
Time Frame: Up to 16 weeks
Changes noted in the size of the treated SCCis lesion site, measured by the longest diameter.
Up to 16 weeks
Local Skin Response Scale
Time Frame: Up to 16 weeks
Observations and changes noted in the aesthetic appearance (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/ Pustulation, Erosion/ Ulceration) of thetreated isSCC lesion will each be graded on a scale of 0 to 4, with 0 as no presenceand 4 as a severe outcome.
Up to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Center for Clinical and Cosmetic Research

Collaborators

Biofrontera, Inc.

Investigators

  • Principal Investigator: Mark S Nestor, MD, PhD, Center for Clinical and Cosmetic Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

August 27, 2024

First Submitted That Met QC Criteria

August 27, 2024

First Posted (Actual)

August 29, 2024

Study Record Updates

Last Update Posted (Actual)

August 29, 2024

Last Update Submitted That Met QC Criteria

August 27, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCCR 01-2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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