Clinical trial · Interventional

Photodynamic Therapy for Treatment of Cutaneous Squamous Cell Carcinoma in Situ

NCT03025724CI-TRIAL-00025535unknownN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Squamous Cell Carcinoma	Squamous Cell Carcinoma	ONTOLOGY_EXACT	0.98

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
blue light source	Device	—	UNRESOLVED
Levulan Kerastick	Drug	Aminolevulinic Acid	ALIAS
participant satisfaction survey	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
NO_INTERVENTION
label
Control
description
After the surgical excision, subjects will be asked to fill out a satisfaction survey. They will not receive any PDT treatment.
type
EXPERIMENTAL
label
Intervention Group
description
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.
interventionNames
1. Drug: Levulan Kerastick
2. Device: blue light source
3. Other: participant satisfaction survey

Primary outcomes (1)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

1. Age \> 18, any gender
2. Biopsy proven SCCis without evidence of microinvasion beyond the epidermis
3. Low-risk site (trunk, arms, legs)
4. Clinical presence of tumor at biopsy site to ensure that biopsy itself was not curative
5. Lesion \<2cm
6. Subject amenable to surgical excision at 6 months after the last PDT treatment

Exclusion Criteria:

1. High-risk site (head, neck, hands, feet)
2. Previous severe adverse reaction to topical 20% aminolevulinic acid (Kerastick)
3. Previous severe adverse reaction to blue light (BLU-U)
4. Allergy to Tegaderm
5. Exclusion of any patient with primary or secondary immunosuppression
6. History of \> 6 skin cancers in the past year
7. Photosensitizing condition such as lupus
8. Sensitivity to porphyrins

References

Publications (7)

BACKGROUNDGreen A. Changing patterns in incidence of non-melanoma skin cancer. Epithelial Cell Biol. 1992 Jan;1(1):47-51. PMID 1307938
BACKGROUNDGlass AG, Hoover RN. The emerging epidemic of melanoma and squamous cell skin cancer. JAMA. 1989 Oct 20;262(15):2097-100. PMID 2795783
BACKGROUNDBrancaleon 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
BACKGROUNDKennedy 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
BACKGROUNDTierney 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
RESULTRogers 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
RESULTMiller 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