Cutaneous Squamous Cell CarcinomaPhase 2NCT06577311
Evaluating the Use of Photodynamic Therapy to Treat Facial Cutaneous Squamous Cell Carcinoma in Situ (SCCis)
A Phase 2 study testing Aminolevulinic acid hydrochloride 10% topical gel with Red Light in people with Cutaneous Squamous Cell Carcinoma, run by The Center for Clinical and Cosmetic Research at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Squamous Cell Carcinoma
- What is being tested?
- Aminolevulinic acid hydrochloride 10% topical gel with Red Light
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2024to Aug 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Center for Clinical and Cosmetic Research
Aventura, Florida, 33180
Clinical Research Coordinator, 305-933-6716, info@centerforclinicalandcosmeticresearch.com
Mark S. Nestor, MD, PhD, 305-933-6716, nestormd@admcorp.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Cutaneous Squamous Cell Carcinoma
- Being tested
- Aminolevulinic acid hydrochloride 10% topical gel with Red Light
- Keywords
- skin cancer, facial skin cancer, Squamous Cell Carcinoma, Squamous Cell Carcinoma in Situ, Cutaneous Squamous Cell Carcinoma in Situ, Facial Cutaneous Squamous Cell Carcinoma in Situ, SCCis
- Medical subject headings
- Skin Neoplasms, Carcinoma, Squamous Cell, Squamous Intraepithelial Lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aminolevulinic acid hydrochloride 10% topical gel with Red LightCombination product
Also called Ameluz ®, RhodoLED-XL®
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 group | Role | What they receive |
|---|---|---|
| Photodynamic Therapy (using Red light dose) | Experimental | 20 participants will be enrolled to this arm Receives: Combination Product: Aminolevulinic acid hydrochloride 10% topical gel with Red Light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with histological clearance of treated SCCis lesion.
Histological clearance is defined as the absence of detectable evidence of SCCis tumor cell nests by the central pathology reports
Measured: an average of 12 weeks
Secondary outcomes (3)
Number of participants with clinical clearance of treated SCCis lesion
Complete Clinical Clearance will be measured by the Investigator and is defined as when there is no clinically visible lesion remaining at the site
Measured: an average of 12 weeks
Size of the lesion
Changes noted in the size of the treated SCCis lesion site, measured by the longest diameter.
Measured: Up to 16 weeks
Local Skin Response Scale
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.
Measured: Up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start14 Aug 2024
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Center for Clinical and Cosmetic Research
- Sponsor type
- University, hospital or other
- Collaborators
- Biofrontera Inc.
- Responsible party
- Principal investigator, Mark Steven Nestor, M.D., Ph.D., The Center for Clinical and Cosmetic Research
- Investigators
- Mark S Nestor, MD, PhD, Principal investigator, Center for Clinical and Cosmetic Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06577311
- Sponsor's protocol ID
- CCCR 01-2024
- Status last verified
- Aug 2024
- First submitted
- 27 Aug 2024
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)"
- ClinicalTrials.gov ID
- NCT06577311
- Acronym / sponsor ID
- CCCR 01-2024
- Conditions
- Cutaneous Squamous Cell Carcinoma
- Keywords
- skin cancer, facial skin cancer, Squamous Cell Carcinoma, Squamous Cell Carcinoma in Situ, Cutaneous Squamous Cell Carcinoma in Situ, Facial Cutaneous Squamous Cell Carcinoma in Situ, SCCis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Center for Clinical and Cosmetic ResearchUniversity, hospital or other
- Collaborators
- Biofrontera Inc.
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Photodynamic Therapy (using Red light dose) | Experimental | Combination Product: Aminolevulinic acid hydrochloride 10% topical gel with Red Light20 participants will be enrolled to this arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aminolevulinic acid hydrochloride 10% topical gel with Red LightAlso: Ameluz ®, RhodoLED-XL®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. | Combination product | Photodynamic Therapy (using Red light dose) |
Primary outcome
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
3 secondary outcomes
Number of participants with clinical clearance of treated SCCis lesion
Time frame: an average of 12 weeks
Size of the lesion
Time frame: Up to 16 weeks
Local Skin Response Scale
Time frame: Up to 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark S Nestor, MD, PhD principal investigator
Center for Clinical and Cosmetic Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aminolevulinic acid hydrochloride 10% topical gel with Red Light in people with Cutaneous Squamous Cell Carcinoma, run by The Center for Clinical and Cosmetic Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clinical Coordinator (305-933-6716, info@centerforclinicalandcosmeticresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with histological clearance of treated SCCis lesion. (time frame: an average of 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2024.