Efficacy of AFL-assisted PDT in Microinvasive Squamous Cell Carcinoma

Dong-A University

Status and phase

Completed

Phase 1

Conditions

Microinvasive Squamous Cell Carcinoma

Treatments

Device: Illuminating using red light-emitting diode lamps

Drug: methyl-aminolevulinate application

Drug: lidocaine-prilocaine 5% cream application

Device: 2940-nm Er:YAG AFL pretreatment

Study type

Interventional

Funder types

Other

Identifiers

NCT02666534

DAUderma-05

Details and patient eligibility

About

Surgical excision is the standard treatment for cutaneous SCC. However, many patients diagnosed with SCC are elderly and ineligible for surgery. Ablative fractional laser- assisted photodynamic therapy (AFL-PDT) offered a higher efficacy than conventional Methylaminolevulinate (MAL)-PDT.

Full description

Squamous cell carcinoma (SCC) lesions are potentially metastatic and can be life threatening. Hence, surgical excision is the standard treatment for cutaneous SCC. However, some patients are ineligible for surgery because of their poor general health, concomitant anticoagulant or immunosuppressive therapies, or allergy to local anesthetics.

Photodynamic therapy (PDT) with methylaminolevulinate (MAL) is an innovative treatment modality that has been approved in Europe for the treatment of actinic keratosis, basal cell carcinoma, and Bowen's disease. However, currently, there is insufficient evidence to support the routine use of topical PDT for SCC.

Ablative fractional laser (AFL) ablates the epidermis and dermis without significant thermal injury, creating microscopic ablation zones in the portion of the skin that the laser is applied to. Our previous studies showed that AFL-primed MAL-PDT (AFL-PDT) offered a higher efficacy than conventional MAL-PDT in the treatment of many other diseases, such as actinic keratosis, actinic cheilitis, and Bowen's disease.

Investigators recruited Korean patients with microinvasive SCC and compared the efficacy, recurrence rate, and cosmetic outcomes of AFL-PDT with those of standard MAL-PDT.

Enrollment

45 patients

Sex

All

Ages

65 to 89 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Patients aged 18 years or more who had previously untreated microinvasive SCC, providing they satisfied both of the following conditions:
- tumor invasion into the papillary dermis (Clark level II) according to a biopsy specimen and
- difficulty in surgical excision because of health problems (bleeding tendency or cardiac problems)

Exclusion criteria

pregnancy or lactation
active systemic infectious disease
other inflammatory, infectious, or neoplastic skin diseases in the treated area
allergy to MAL,other topical photosensitizers, or excipients of the cream
history of photosensitivity
use of immunosuppressive or photosensitizing drugs
participation in any other investigational study in the preceding 30 days
history or indicators of poor compliance
Histological findings of acantholysis, desmoplasia, perineural or lymphovascular invasion, and echographic features of regional lymph node metastasis were the disease-specific exclusion criteria

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Double Blind

45 participants in 2 patient groups

AFL-PDT

Experimental group

Description:

Forty-five Korean patients were enrolled in this study. Patients were randomly assigned to receive either AFL-PDT or MAL-PDT in a 1:1 ratio. As result, the patients were randomized to treatment with AFL-PDT (21 patients) or MAL-PDT (24 patients)

Treatment:

Device: 2940-nm Er:YAG AFL pretreatment

Drug: lidocaine-prilocaine 5% cream application

Drug: methyl-aminolevulinate application

Device: Illuminating using red light-emitting diode lamps

MAL-PDT

Active Comparator group

Description:

Treatment:

Drug: methyl-aminolevulinate application

Device: Illuminating using red light-emitting diode lamps