Evaluating Photodynamic Therapy Used to Treat Cutaneous Squamous Cell Carcinoma in Situ (isSCC) on the Face, Upper Extremities & Trunk.

November 6, 2026 updated by: The Center for Clinical and Cosmetic Research

An Investigator Initiated Study to Evaluate the Safety and Efficacy of Aminolevulinic Acid 20% Topical Solution (Levulan® Kerastick®) (ALA) With Blue Light Model 4170E in the Treatment of Cutaneous Squamous Cell Carcinoma in Situ (isSCC) Located on the Face, Upper Extremities and Trunk.

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, upper extremities and trunk, using a light sensitive cream 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 skin cancer section the treatment was able to remove, and;
  • seeing how many participants had no remaining affected skin cancer sections after treatment.

Participants who qualify will be asked to complete 12 visits in total and will receive a total of two treatments, after voluntarily consent has been given.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 physical exam, skin type, vital signs, height, weight and urine pregnancy test collection)
  • Follow study rules such as avoiding certain medications and treatments
  • Allow photographs of the area of skin cancer being treated on the face or upper extremities/ trunk.
  • 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 upper extremities/ trunk 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 or upper extremities/ trunk 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 or upper extremities/ trunk 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
  • (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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must be an adult (18 years of age or older).
  • Voluntary written consent required.
  • Must have a recently diagnosed (no more than six months from first study visit) facial or trunk/ upper extremities isSCC (Squamous Cell Carcinoma in situ) lesion that meets surgery excision size requirements.
  • Cannot have other dermatological disease in the isSCC 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.
  • If female, cannot be pregnant before and during the study and agree to use acceptable forms of birth control.

Exclusion Criteria:

  • Sensitive to any of the study treatment ingredients.
  • Pregnant or lactating.
  • Medical laboratory evidence of other non-isSCC tumor in the target lesion biopsy specimen.
  • History of recurrence in the target isSCC lesion.
  • Medical laboratory evidence of certain 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.
  • History of abnormal heart muscles.
  • Currently participating in a research study or have been treated with an investigational product within 30 days from first study treatment.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Facial isSCC Photodynamic Therapy (Blue light dose 20 J/cm2)

8 participants will be enrolled to this arm.
Combination product: Aminolevulinic Acid 20% Topical Solution with Blue Light (dose 20 J/cm2)

Participants will have their isSCC lesions prepped then treated with Aminolevulinic Acid 20% Topical Solution (Levulan® Kerastick® Applicators) (ALA), followed by Blue Light therapy administered for 16 minutes and 40 seconds to deliver the total desired light dose to the isSCC lesion.

Other Names:
  • BLU-U® Blue Light Photodynamic Therapy Illuminator
  • Levulan® Kerastick®
Experimental: Trunk and/or upper extremities isSCC Photodynamic Therapy (Blue light dose 20 J/cm2)

8 participants will be enrolled to this arm.
Combination product: Aminolevulinic Acid 20% Topical Solution with Blue Light (dose 20 J/cm2)

Participants will have their isSCC lesions prepped then treated with Aminolevulinic Acid 20% Topical Solution (Levulan® Kerastick® Applicators) (ALA), followed by Blue Light therapy administered for 16 minutes and 40 seconds to deliver the total desired light dose to the isSCC lesion.

Other Names:
  • BLU-U® Blue Light Photodynamic Therapy Illuminator
  • Levulan® Kerastick®
Experimental: Facial isSCC Photodynamic Therapy (Blue light dose 10 J/cm2)

7 participants will be enrolled to this arm.
Combination product: Aminolevulinic Acid 20% Topical Solution with Blue Light (dose 10 J/cm2)

Participants will have their isSCC lesions prepped then treated with Aminolevulinic Acid 20% Topical Solution (Levulan® Kerastick® Applicators) (ALA), followed by Blue Light therapy administered for 8 minutes and 20 seconds to deliver the total desired light dose to the isSCC lesion.

Other Names:
  • BLU-U® Blue Light Photodynamic Therapy Illuminator
  • Levulan® Kerastick®
Experimental: Trunk and/or upper extremities isSCC Photodynamic Therapy (Blue light dose 10 J/cm2)

7 participants will be enrolled to this arm.
Combination product: Aminolevulinic Acid 20% Topical Solution with Blue Light (dose 10 J/cm2)

Participants will have their isSCC lesions prepped then treated with Aminolevulinic Acid 20% Topical Solution (Levulan® Kerastick® Applicators) (ALA), followed by Blue Light therapy administered for 8 minutes and 20 seconds to deliver the total desired light dose to the isSCC lesion.

Other Names:
  • BLU-U® Blue Light Photodynamic Therapy Illuminator
  • Levulan® Kerastick®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants with Histological Clearance of treated isSCC lesion
Time Frame: Up to 63 days after treatment 2.

Histological clearance is defined as the absence of detectable evidence of isSCC tumor cell nests by the central pathology reports
Up to 63 days after treatment 2.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants with clinical clearance of treated isSCC lesion
Time Frame: Up to 63 days after treatment 2.

Complete Clinical Clearance will be measured by the Investigator and is defined as when there is no clinically visible lesion remaining at the site.
Up to 63 days after treatment 2.
Local Skin Response Scale
Time Frame: Up to 63 days after treatment 2

Observations and changes noted in the aesthetic appearance of the treated isSCC lesion site.
Up to 63 days after treatment 2

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Center for Clinical and Cosmetic Research

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sun Pharmaceutical Industries Limited

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 25, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CCCR 02-2024

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.

No

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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