Clinical trial NCT02666534: Efficacy of AFL-assisted PDT in Microinvasive Squamous Cell Carcinoma
Official title: A Randomised Trial Comparing Methyl Aminolaevulinate Photodynamic Therapy With and Without Ablative Fractional Laser Treatment in Patients With Microinvasive Squamous Cell Carcinoma: Results From a 24-month Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Microinvasive Squamous Cell Carcinoma
Keywords: Ablative fractional laser
microinvasive squamous cell carcinoma
photodynamic therapy
Lead sponsor: Dong-A University
Sponsor class: OTHER
First posted: 2016-01-28
Enrollment: 45
Sex: ALL
Minimum age (years): 65
Maximum age (years): 89
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference of short-term complete response (CR) rate between AFL-PDT and MAL-PDT
timeFrame: Short-term CR rate was evaluated at 3 months
measure: Difference of long-term complete response (CR) rate between AFL-PDT and MAL-PDT
timeFrame: Long-term CR rate was evaluated at 24 months
measure: Difference of recurrence rate at 24 months
timeFrame: Recurrent rate was evaluated at 24months
Secondary outcomes:
measure: Difference of the cosmetic outcome between AFL-PDT and MAL-PDT
timeFrame: Cosmetic outcome was assessed by each investigator for all lesions that achieved a complete response at 24 months
Other outcomes:
measure: Differences of Adverse events(erythema, burning sensation, swelling, bleeding) between AFL-PDT and MAL-PDT
timeFrame: Within 24 months after each treatment
Locations:
city: Busan
country: Korea, Republic of
facility: Dong-A University
state: Dong dae sin-dong, Seo-gu
Study officials:
References:
citation: Choi SH, Kim KH, Song KH. Effect of Methyl Aminolevulinate Photodynamic Therapy With and Without Ablative Fractional Laser Treatment in Patients With Microinvasive Squamous Cell Carcinoma: A Randomized Clinical Trial. JAMA Dermatol. 2017 Mar 1;153(3):289-295. doi: 10.1001/jamadermatol.2016.4463.