Efficacy of AFL-assisted PDT in Microinvasive Squamous Cell Carcinoma

Phase 1

Completed

• Conditions: Microinvasive Squamous Cell Carcinoma
• Interventions: Drug: lidocaine-prilocaine 5% cream application; Drug: methyl-aminolevulinate application; Device: Illuminating using red light-emitting diode lamps

• Registration Number: NCT02666534
• Lead Sponsor: Dong-A University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-01
• Study First Submitted: 2016-01-21
• Study First Submitted QC: 2016-01-27
• Last Update Submitted: 2016-01-27
• Study First Posted: 2016-01-28
• Last Update Posted: 2016-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
MAL-PDT	Illuminating using red light-emitting diode lamps	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)
AFL-PDT	lidocaine-prilocaine 5% cream application	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)
MAL-PDT	methyl-aminolevulinate application	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)
AFL-PDT	methyl-aminolevulinate application	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)
AFL-PDT	Illuminating using red light-emitting diode lamps	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)

Primary Outcome Measures

Name	Time	Method
Difference of short-term complete response (CR) rate between AFL-PDT and MAL-PDT	Short-term CR rate was evaluated at 3 months	The response was classified as either complete response (complete disappearance of the lesion) or incomplete response (incomplete disappearance of the lesion)
Difference of recurrence rate at 24 months	Recurrent rate was evaluated at 24months	In all cases of complete response, the patients were reviewed at 24 months to check for recurrence. Post-therapy punch biopsies were performed when there was doubt concerning incomplete-response and clinical recurrence
Difference of long-term complete response (CR) rate between AFL-PDT and MAL-PDT	Long-term CR rate was evaluated at 24 months	The response was classified as either complete response (complete disappearance of the lesion) or incomplete response (incomplete disappearance of the lesion)

Secondary Outcome Measures

Name	Time	Method
Difference of the cosmetic outcome between AFL-PDT and MAL-PDT	Cosmetic outcome was assessed by each investigator for all lesions that achieved a complete response at 24 months	The overall cosmetic outcome was assessed by each investigator for all lesions that achieved complete response at 24 months, and was graded using a 4-point scale: excellent (only slight occurrence of redness or change in pigmentation), good (moderate redness or change in pigmentation), fair (slight to moderate scarring, atrophy, or induration), or poor (extensive scarring, atrophy, or induration)

Trial Locations

Locations (1)

Dong-A University; 🇰🇷 Busan, Dong dae sin-dong, Seo-gu, Korea, Republic of