Squamous Cell CarcinomaNCT03025724
Photodynamic Therapy for Treatment of Cutaneous Squamous Cell Carcinoma in Situ
A study testing Levulan Kerastick, blue light source and participant satisfaction survey in people with Squamous Cell Carcinoma, run by Rhode Island Hospital.
Trial summary
This pilot study will evaluate the effectiveness of using photodynamic therapy for treatment of cutaneous squamous cell in situ (SCCis). Our hypothesis is that PDT will be effective for treating SCCis. This study will also secondarily evaluate the tolerability of using photodynamic therapy for treatment of SCCis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma
- What is being tested?
- Levulan Kerastick, blue light source and participant satisfaction survey
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jan 2020
- Phase
- Interventional
- 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
- Age > 18, any gender
- Biopsy proven SCCis without evidence of microinvasion beyond the epidermis
- Low-risk site (trunk, arms, legs)
- Clinical presence of tumor at biopsy site to ensure that biopsy itself was not curative
- Lesion <2cm
- Subject amenable to surgical excision at 6 months after the last PDT treatment
Who cannot join
- High-risk site (head, neck, hands, feet)
- Previous severe adverse reaction to topical 20% aminolevulinic acid (Kerastick)
- Previous severe adverse reaction to blue light (BLU-U)
- Allergy to Tegaderm
- Exclusion of any patient with primary or secondary immunosuppression
- History of > 6 skin cancers in the past year
- Photosensitizing condition such as lupus
- Sensitivity to porphyrins
Trial locations and contacts
No sites are listed yet.
About this study
This pilot study will evaluate the effectiveness of using photodynamic therapy for treatment of cutaneous squamous cell in situ (SCCis). Our hypothesis is that PDT will be effective for treating SCCis. This study will also secondarily evaluate the tolerability of using photodynamic therapy for treatment of SCCis.
Investigators plan to enroll 40 subjects with biopsy proven SCCis. Exclusion criteria include lesion in high-risk site (head, neck, hands, feet), previous severe adverse reaction to topical 20% aminolevulinic acid (Kerastick), previous severe adverse reaction to blue light (BLU-U), allergy to Tegaderm, primary or secondary immunosuppression, history of > 6 skin cancers in the past year, photosensitizing condition such as lupus, or sensitivity to porphyrins.
Age, gender, size, and location of the SCCis will be recorded. All subjects will receive surgical treatment of their SCCis. The control group will undergo a surgical excision of the tumor. After the excision, subjects will be asked to fill out a satisfaction survey. The intervention group will receive PDT plus surgical treatment. Photographs of the lesion will be taken at each study visit. Subjects in the intervention group will then undergo the study procedure of application of topical 20% 5-ALA (Levulan Kerastick; DUSA Pharmaceuticals) to the SCCis. At 3-5 weeks after the initial treatment, the subject will repeat the 3-hour ALA incubation and blue light exposure. At 6 months after the last treatment, subjects in the intervention group will return for clinical follow-up and surgical excision of the lesion. After excision, the specimen will be sent for processing by pathology and subjects will be asked to fill out a satisfaction visual analog scale. All slides will be read by a board-certified dermatopathologist. Side effects will also be monitored using the same graded scale described previously. Mild adverse events that have been associated with PDT, including erythema, skin crusting, superficial blistering, hypopigmentation, and hyperpigmentation. These reactions usually occur during or immediately after the PDT treatment.
Read the detailed description
Objective: This trial will evaluate the effectiveness of photodynamic therapy (aminolevulinic acid plus blue light) for treatment of cutaneous squamous cell carcinoma in situ (SCCis).
This pilot study will prospectively recruit 40 subjects with biopsy proven SCCis at the time of their visit at University Dermatology East Providence office. Exclusion criteria include lesion in high-risk site (head, neck, hands, feet), previous severe adverse reaction to topical 20% aminolevulinic acid (Kerastick), previous severe adverse reaction to blue light (BLU-U), allergy to Tegaderm, primary or secondary immunosuppression, history of > 6 skin cancers in the past year, photosensitizing condition such as lupus, or sensitivity to porphyrins.
Half of the subjects will be randomized to the control group (n=20), and the remaining subjects (n=20) will be randomized to the intervention group. The subject's age and gender, and size and location of the SCCis will be recorded. For the control group, subjects will undergo a surgical excision of the tumor, which is the gold standard of treatment for SCCis. After the excision, subjects will be asked to fill out a satisfaction survey. They will not receive any PDT treatment.
For the intervention group, photographs of the lesion will be taken at each study visit. A clear transparency film will be used to trace the clinical margins of the lesion, as well as any other distinctive skin markings such as nevi or birthmarks. Subjects will then undergo the study procedure. The area to be treated will be swabbed with an alcohol wipe and allowed to dry. The investigator will apply topical 20% 5-ALA to the SCCis. Then, the area will be covered with Tegaderm film for 3 hours. At the end of 3 hours, the Tegaderm will be removed and the subject will be exposed to a blue light source, which is the standard protocol for treatment with blue light PDT. During administration of the light and immediately afterwards, the subject will be monitored for any side effects, such as erythema, edema, stinging/burning, blisters/crusting, hyperpigmentation, and hypopigmentation. These items will be graded on a scale of 1 to 4 (1=mild and 4=severe) assessed immediately after treatment. This process will be repeated at the next visit 3-5 weeks later. At six months after the last treatment, subjects in the intervention group will return for clinical follow-up and surgical excision of the lesion. Patients will complete a satisfaction survey at the end of this visit.
- Conditions
- Squamous Cell Carcinoma
- Being tested
- Levulan Kerastick, blue light source, participant satisfaction survey
- Medical subject headings
- Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levulan KerastickDrug
Also called Intervention Group
Intervention group subjects will undergo a surgical excision of the tumor. Then a clear transparency film will be used to trace the clinical margins of the lesion, as well as any other distinctive skin markings such as nevi or birthmarks. Subjects will then undergo the study procedure where the area to be treated will be swabbed with an alcohol wipe and allowed to dry. Next, the investigator will apply topical 20% 5-ALA (Levulan Kerastick; DUSA Pharmaceuticals) to the SCCis. Then, the area will be occluded with Tegaderm film for 3 hours.
blue light sourceDevice
At the end of the incubation period, the Tegaderm will be removed and the patient will be exposed to a blue light source (BLU-U; DUSA Pharmaceuticals).
participant satisfaction surveyOther
Participants will be asked to fill out a satisfaction survey.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | After the surgical excision, subjects will be asked to fill out a satisfaction survey. They will not receive any PDT treatment. |
| Intervention Group | Experimental | Subjects will undergo a surgical excision of the tumor. Then a clear transparency film will be used to trace the clinical margins of the lesion, as well as any other distinctive skin markings such as nevi or birthmarks. Subjects will then undergo the study procedure where the area to be treated will be swabbed with an alcohol wipe and allowed to dry. Next, the investigator will apply topical 20% 5-ALA (Levulan Kerastick; DUSA Pharmaceuticals) to the SCCis. Then, the area will be occluded with Tegaderm film for 3 hours. At the end of the incubation period, the Tegaderm will be removed and the patient will be exposed to a blue light source (BLU-U; DUSA Pharmaceuticals). Lastly, they will be asked to fill out a satisfaction survey. Receives: Drug: Levulan Kerastick; Device: blue light source; Other: participant satisfaction survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the incidence of SCCis present after exposure to the experimental procedures
After the excision, investigators will collect patient satisfaction data. Investigators will also review the final pathology report for presence or absence of the tumor.
Measured: six months
Secondary outcomes (1)
Physician graded scoring on a 1 to 4 scale of erythema, edema, stinging/burning, blisters/crusting, hyperpigmentation, and hypopigmentation.
The subjects will be monitored for any side effects, such as erythema, edema, stinging/burning, blisters/crusting, hyperpigmentation, and hypopigmentation. These items will be graded on a scale of 1 to 4 (1=mild and 4=severe) assessed immediately after treatment.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- DUSA Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Kachiu C. Lee, MD, Principal investigator, University Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03025724
- Sponsor's protocol ID
- 897494
- Status last verified
- Dec 2016
- First submitted
- 21 Dec 2016
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Green A. Changing patterns in incidence of non-melanoma skin cancer. Epithelial Cell Biol. 1992 Jan;1(1):47-51.
PubMed 1307938Glass AG, Hoover RN. The emerging epidemic of melanoma and squamous cell skin cancer. JAMA. 1989 Oct 20;262(15):2097-100.
PubMed 2795783Brancaleon L, Moseley H. Laser and non-laser light sources for photodynamic therapy. Lasers Med Sci. 2002;17(3):173-86. doi: 10.1007/s101030200027.
PubMed 12181632Kennedy JC, Pottier RH, Pross DC. Photodynamic therapy with endogenous protoporphyrin IX: basic principles and present clinical experience. J Photochem Photobiol B. 1990 Jun;6(1-2):143-8. doi: 10.1016/1011-1344(90)85083-9.
PubMed 2121931Tierney E, Barker A, Ahdout J, Hanke CW, Moy RL, Kouba DJ. Photodynamic therapy for the treatment of cutaneous neoplasia, inflammatory disorders, and photoaging. Dermatol Surg. 2009 May;35(5):725-46. doi: 10.1111/j.1524-4725.2009.01117.x. Epub 2009 Mar 20.
PubMed 19309338Rogers HW, Weinstock MA, Harris AR, Hinckley MR, Feldman SR, Fleischer AB, Coldiron BM. Incidence estimate of nonmelanoma skin cancer in the United States, 2006. Arch Dermatol. 2010 Mar;146(3):283-7. doi: 10.1001/archdermatol.2010.19.
PubMed 20231499Miller DL, Weinstock MA. Nonmelanoma skin cancer in the United States: incidence. J Am Acad Dermatol. 1994 May;30(5 Pt 1):774-8. doi: 10.1016/s0190-9622(08)81509-5.
PubMed 8176018
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photodynamic Therapy for Treatment of Cutaneous Squamous Cell Carcinoma in Situ
- ClinicalTrials.gov ID
- NCT03025724
- Acronym / sponsor ID
- 897494
- Conditions
- Squamous Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- DUSA Pharmaceuticals, Inc.
- Study start
- Jan 2017
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 19 Jan 2017 (estimated)
- 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.
This pilot study will evaluate the effectiveness of using photodynamic therapy for treatment of cutaneous squamous cell in situ (SCCis). Our hypothesis is that PDT will be effective for treating SCCis. This study will also secondarily evaluate the tolerability of using photodynamic therapy for treatment of SCCis.
Investigators plan to enroll 40 subjects with biopsy proven SCCis. Exclusion criteria include lesion in high-risk site (head, neck, hands, feet), previous severe adverse reaction to topical 20% aminolevulinic acid (Kerastick), previous severe adverse reaction to blue light (BLU-U), allergy to Tegaderm, primary or secondary immunosuppression, history of > 6 skin cancers in the past year, photosensitizing condition such as lupus, or sensitivity to porphyrins.
Age, gender, size, and location of the SCCis will be recorded. All subjects will receive surgical treatment of their SCCis. The control group will undergo a surgical excision of the tumor. After the excision, subjects will be asked to fill out a satisfaction survey. The intervention group will receive PDT plus surgical treatment. Photographs of the lesion will be taken at each study visit. Subjects in the intervention group will then undergo the study procedure of application of topical 20% 5-ALA (Levulan Kerastick; DUSA Pharmaceuticals) to the SCCis. At 3-5 weeks after the initial treatment, the subject will repeat the 3-hour ALA incubation and blue light exposure. At 6 months after the last treatment, subjects in the intervention group will return for clinical follow-up and surgical excision of the lesion. After excision, the specimen will be sent for processing by pathology and subjects will be asked to fill out a satisfaction visual analog scale. All slides will be read by a board-certified dermatopathologist. Side effects will also be monitored using the same graded scale described previously. Mild adverse events that have been associated with PDT, including erythema, skin crusting, superficial blistering, hypopigmentation, and hyperpigmentation. These reactions usually occur during or immediately after the PDT treatment.
Detailed description
Objective: This trial will evaluate the effectiveness of photodynamic therapy (aminolevulinic acid plus blue light) for treatment of cutaneous squamous cell carcinoma in situ (SCCis).
This pilot study will prospectively recruit 40 subjects with biopsy proven SCCis at the time of their visit at University Dermatology East Providence office. Exclusion criteria include lesion in high-risk site (head, neck, hands, feet), previous severe adverse reaction to topical 20% aminolevulinic acid (Kerastick), previous severe adverse reaction to blue light (BLU-U), allergy to Tegaderm, primary or secondary immunosuppression, history of > 6 skin cancers in the past year, photosensitizing condition such as lupus, or sensitivity to porphyrins.
Half of the subjects will be randomized to the control group (n=20), and the remaining subjects (n=20) will be randomized to the intervention group. The subject's age and gender, and size and location of the SCCis will be recorded. For the control group, subjects will undergo a surgical excision of the tumor, which is the gold standard of treatment for SCCis. After the excision, subjects will be asked to fill out a satisfaction survey. They will not receive any PDT treatment.
For the intervention group, photographs of the lesion will be taken at each study visit. A clear transparency film will be used to trace the clinical margins of the lesion, as well as any other distinctive skin markings such as nevi or birthmarks. Subjects will then undergo the study procedure. The area to be treated will be swabbed with an alcohol wipe and allowed to dry. The investigator will apply topical 20% 5-ALA to the SCCis. Then, the area will be covered with Tegaderm film for 3 hours. At the end of 3 hours, the Tegaderm will be removed and the subject will be exposed to a blue light source, which is the standard protocol for treatment with blue light PDT. During administration of the light and immediately afterwards, the subject will be monitored for any side effects, such as erythema, edema, stinging/burning, blisters/crusting, hyperpigmentation, and hypopigmentation. These items will be graded on a scale of 1 to 4 (1=mild and 4=severe) assessed immediately after treatment. This process will be repeated at the next visit 3-5 weeks later. At six months after the last treatment, subjects in the intervention group will return for clinical follow-up and surgical excision of the lesion. Patients will complete a satisfaction survey at the end of this visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –After the surgical excision, subjects will be asked to fill out a satisfaction survey. They will not receive any PDT treatment. |
| Intervention Group | Experimental | Drug: Levulan Kerastick, Device: blue light source, Other: participant satisfaction surveySubjects will undergo a surgical excision of the tumor. Then a clear transparency film will be used to trace the clinical margins of the lesion, as well as any other distinctive skin markings such as nevi or birthmarks. Subjects will then undergo the study procedure where the area to be treated will be swabbed with an alcohol wipe and allowed to dry. Next, the investigator will apply topical 20% 5-ALA (Levulan Kerastick; DUSA Pharmaceuticals) to the SCCis. Then, the area will be occluded with Tegaderm film for 3 hours. At the end of the incubation period, the Tegaderm will be removed and the patient will be exposed to a blue light source (BLU-U; DUSA Pharmaceuticals). Lastly, they will be asked to fill out a satisfaction survey. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18, any gender
- Biopsy proven SCCis without evidence of microinvasion beyond the epidermis
- Low-risk site (trunk, arms, legs)
- Clinical presence of tumor at biopsy site to ensure that biopsy itself was not curative
- Lesion <2cm
Key exclusion criteria (8 listed)
- High-risk site (head, neck, hands, feet)
- Previous severe adverse reaction to topical 20% aminolevulinic acid (Kerastick)
- Previous severe adverse reaction to blue light (BLU-U)
- Allergy to Tegaderm
- Exclusion of any patient with primary or secondary immunosuppression
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 |
|---|---|---|
| Levulan KerastickAlso: Intervention GroupIntervention group subjects will undergo a surgical excision of the tumor. Then a clear transparency film will be used to trace the clinical margins of the lesion, as well as any other distinctive skin markings such as nevi or birthmarks. Subjects will then undergo the study procedure where the area to be treated will be swabbed with an alcohol wipe and allowed to dry. Next, the investigator will apply topical 20% 5-ALA (Levulan Kerastick; DUSA Pharmaceuticals) to the SCCis. Then, the area will be occluded with Tegaderm film for 3 hours. | Drug | Intervention Group |
| blue light sourceAt the end of the incubation period, the Tegaderm will be removed and the patient will be exposed to a blue light source (BLU-U; DUSA Pharmaceuticals). | Device | Intervention Group |
| participant satisfaction surveyParticipants will be asked to fill out a satisfaction survey. | Other | Intervention Group |
Primary outcome
Evaluate the incidence of SCCis present after exposure to the experimental procedures
Time frame: six months
After the excision, investigators will collect patient satisfaction data. Investigators will also review the final pathology report for presence or absence of the tumor.
1 secondary outcome
Physician graded scoring on a 1 to 4 scale of erythema, edema, stinging/burning, blisters/crusting, hyperpigmentation, and hypopigmentation.
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
- Background: PubMed 1307938Green A. Changing patterns in incidence of non-melanoma skin cancer. Epithelial Cell Biol. 1992 Jan;1(1):47-51.
- Background: PubMed 2795783Glass AG, Hoover RN. The emerging epidemic of melanoma and squamous cell skin cancer. JAMA. 1989 Oct 20;262(15):2097-100.
- Background: PubMed 12181632Brancaleon L, Moseley H. Laser and non-laser light sources for photodynamic therapy. Lasers Med Sci. 2002;17(3):173-86. doi: 10.1007/s101030200027.
- Background: PubMed 2121931Kennedy JC, Pottier RH, Pross DC. Photodynamic therapy with endogenous protoporphyrin IX: basic principles and present clinical experience. J Photochem Photobiol B. 1990 Jun;6(1-2):143-8. doi: 10.1016/1011-1344(90)85083-9.
- Background: PubMed 19309338Tierney E, Barker A, Ahdout J, Hanke CW, Moy RL, Kouba DJ. Photodynamic therapy for the treatment of cutaneous neoplasia, inflammatory disorders, and photoaging. Dermatol Surg. 2009 May;35(5):725-46. doi: 10.1111/j.1524-4725.2009.01117.x. Epub 2009 Mar 20.
- Results publication: PubMed 20231499Rogers HW, Weinstock MA, Harris AR, Hinckley MR, Feldman SR, Fleischer AB, Coldiron BM. Incidence estimate of nonmelanoma skin cancer in the United States, 2006. Arch Dermatol. 2010 Mar;146(3):283-7. doi: 10.1001/archdermatol.2010.19.
- Results publication: PubMed 8176018Miller DL, Weinstock MA. Nonmelanoma skin cancer in the United States: incidence. J Am Acad Dermatol. 1994 May;30(5 Pt 1):774-8. doi: 10.1016/s0190-9622(08)81509-5.
- Individual participant dataSharing planned: No
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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.
Kachiu C. Lee, MD principal investigator
University Dermatology
Questions about this trial
What is this clinical trial studying?
A study testing Levulan Kerastick, blue light source and participant satisfaction survey in people with Squamous Cell Carcinoma, run by Rhode Island Hospital.
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 6 inclusion and 8 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 19 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Steven K. Knapp, BA (401-444-7853, sknapp@lifespan.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the incidence of SCCis present after exposure to the experimental procedures (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03025724, which also lists 7 linked publications.
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 19 Jan 2017.