Clinical trial NCT02018679: Er:YAG Ablative Fractional Laser Assisted-Photodynamic Therapy Versus Photodynamic Therapy for Basal Cell Carcinoma
Official title: Er:YAG Ablative Fractional Laser Assisted-Photodynamic Therapy Versus Photodynamic Therapy for Nodular Basal Cell Carcinoma in Asian: A Prospective, Randomized Study With 12 Months Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Nodular Basal Cell Carcinoma
Keywords: Nodular basal cell carcinoma
Er:YAG
AFL-assisted
MAL-PDT
Lead sponsor: Dong-A University
Sponsor class: OTHER
First posted: 2013-12-23
Enrollment: 34
Sex: ALL
Minimum age (years): 38
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Topical photodynamic therapy with methyl-aminolaevulinate (MAL-PDT) has been introduced as an alternatively attractive procedure for BCC. Er:YAG ablative fractional laser (AFL) treatment removes the stratum corneum to increase MAL uptake and may improve efficacy. However, no studies have directly compared the efficacy of Er:YAG AFL-PDT and MAL-PDT in treating nodular BCC in Asians.

Detailed description: Basal cell carcinoma (BCC) is the most common cancer in the Caucasian population, with an incidence rising worldwide. there is an increasing trend in the incidence rates of BCC in asian and greater percentage of pigmented BCCs is found to be the most characteristic clinical feature of BCC in Asian compared to BCC in Caucasians. Topical photodynamic therapy with methyl-aminolaevulinate (MAL-PDT) has been introduced as an alternatively attractive procedure for BCC. PDT facilitates the light activation of a photosensitizer in the presence of oxygen. The oxygen generates reactive oxygen species leading to selective and highly localized destruction of abnormal cells. MAL is an efficient photosensitizer as a result of improved lesion penetration attributed to enhanced lipophilicity, decreased charge and also has a greater specificity for neoplastic cells, compared with 5-aminolevulinic acid. Because histologic features of nBCC include down-growth of epithelial buds into the dermis, palisading basal cell and separation of epidermis from the underlying dermis, it is generally treated twice within an interval of 1 week.But, MAL-PDT shows the lower efficacy for the treatment of pigmented BCC because melanin disturbs the absorption of the MAL. Also, a significantly higher proportions of BCC in the Asian population were pigmented BCC compared with pigmented BCC of Caucasian. Consequently, additional techniques are needed to enhance the penetration and accumulation of MAL in order to improve PDT efficacy and decrease treatment duration in darker-skinned patients.

Er:YAG ablative fractional laser therapy (AFL) can ablate the epidermis and dermis without significant thermal injury. This approach creates microscopic ablation zones (MAZ) in laser-applied portion of the skin. The tissue with MAZ is surrounded by thin layers of coagulated tissue. Since the Er:YAG AFL resurfaces 5-20% of the skin at one time and does not injure the entire thickness of the epidermis, healing times are minimized. Recent studies have demonstrated that Er:YAG AFL facilitates delivery and uptake of topical MAL deep into the skin, enhancing porphyrin synthesis and photodynamic activation. We have compared the efficacy, recurrence rate, cosmetic outcomes and safety of Er:YAG AFL-PDT with standard MAL-PDT in the treatment of nBCC among Korean populations.

Eligibility criteria: Inclusion Criteria:

* patient's request for alternative treatment due to the lower cosmetic outcomes of surgery
* difficulty to surgical excision due to bleeding abnormalities or cardiac problems

Exclusion Criteria:

* patients with more than 5 eligible lesions
* lesions deeper than 2mm in depth
* lesions located in the midface region, nose, orbital areas, and ears
* lesions with a longest diameter of less than 6 mm or more than 15mm
* infiltrative BCC
* morpheaform BCC
* known allergies to the MAL cream or lidocaine
* pregnancy
* lactation
* any active systemic infectious disease
* immunosuppressive treatment
* personal history of malignant melanoma
* tendency towards melasma or keloid formation
* prior treatment of the lesions within 4 weeks
* any indication of poor compliance

Primary outcomes:
measure: Difference the efficacy between Er:YAG AFL-PDT and MAL-PDT
timeFrame: Efficacy was evaluated at 3 months and 12 months after treatment
Secondary outcomes:
measure: Difference of the cosmetic outcomes between Er:YAG AFL-PDT and MAL-PDT treatment
timeFrame: Cosmetic outcome was assessed by each investigator for all lesions that achieved a complete response at 3 or 12 months
Other outcomes:
measure: Difference of the recurrence rates between Er:YAG AFL-PDT and MAL-PDT
timeFrame: recurrence rates were evaluated at 12 months after the last treatment.
measure: Difference of the safety between Er:YAG AFL-PDT and MAL-PDT
timeFrame: Safety assessments were performed at the end of the 3-hour cream application; after the illumination during each treatment session; and at 1 week, 3 months, and 12 months after the last treatment
Locations:
city: Busan
country: Korea, Republic of
facility: Dong-A University
state: Seo-gu
Study officials:
affiliation: Dong-A University
name: Ki-Hoon Song, M.D., Ph.D.
role: STUDY_CHAIR
References: