Photodynamic Therapy for Treatment of Cutaneous Squamous Cell Carcinoma in Situ

NCT03025724 | Unknown DMC

• 1 other identifier: 897494
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  six months

Secondary Outcomes (1)

• Physician graded scoring on a 1 to 4 scale of erythema, edema, stinging/burning, blisters/crusting, hyperpigmentation, and hypopigmentation.

  six months

Study Arms (2)

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.

Drug: Levulan Kerastick; Device: blue light source; Other: participant satisfaction survey

Interventions

Levulan Kerastick DRUG

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.

Also known as: Intervention Group

Intervention Group

blue light source DEVICE

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).

Intervention Group

participant satisfaction survey OTHER

Participants will be asked to fill out a satisfaction survey.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• History of \> 6 skin cancers in the past year
• Photosensitizing condition such as lupus
• Sensitivity to porphyrins

Sponsors & Collaborators

• Rhode Island Hospital: lead
• DUSA Pharmaceuticals, Inc.: collaborator

Related Publications (7)

• Green A. Changing patterns in incidence of non-melanoma skin cancer. Epithelial Cell Biol. 1992 Jan;1(1):47-51.

  PMID: 1307938 BACKGROUND

• Glass AG, Hoover RN. The emerging epidemic of melanoma and squamous cell skin cancer. JAMA. 1989 Oct 20;262(15):2097-100.

  PMID: 2795783 BACKGROUND

• Brancaleon L, Moseley H. Laser and non-laser light sources for photodynamic therapy. Lasers Med Sci. 2002;17(3):173-86. doi: 10.1007/s101030200027.

  PMID: 12181632 BACKGROUND

• Kennedy 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.

  PMID: 2121931 BACKGROUND

• Tierney 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.

  PMID: 19309338 BACKGROUND

• Rogers 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.

  PMID: 20231499 RESULT

• Miller 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.

  PMID: 8176018 RESULT

MeSH Terms

Conditions

Carcinoma, Squamous Cell

Interventions

Aminolevulinic Acid

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Kachiu C. Lee, MD

  University Dermatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven K. Knapp, BA

CONTACT

401-444-7853; sknapp@lifespan.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2016
• First Posted: January 19, 2017
• Study Start: January 1, 2017
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: January 19, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share