Er:YAG Ablative Fractional Laser Assisted-Photodynamic Therapy Versus Photodynamic Therapy for Basal Cell Carcinoma

NCT02018679 | Completed Phase 1

• 1 other identifier: DAUDerma-02
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Nodular Basal Cell Carcinoma

Keywords

Nodular basal cell carcinoma; Er:YAG; AFL-assisted; MAL-PDT

Outcome Measures

Primary Outcomes (1)

• Difference the efficacy between Er:YAG AFL-PDT and MAL-PDT

  Lesion responses were classified as either a complete response (complete disappearance of the lesion) or a non-complete response (incomplete disappearance)

  Efficacy was evaluated at 3 months and 12 months after treatment

Secondary Outcomes (1)

• Difference of the cosmetic outcomes between Er:YAG AFL-PDT and MAL-PDT treatment

  Cosmetic outcome was assessed by each investigator for all lesions that achieved a complete response at 3 or 12 months

Other Outcomes (2)

• Difference of the recurrence rates between Er:YAG AFL-PDT and MAL-PDT

  recurrence rates were evaluated at 12 months after the last treatment.

• Difference of the safety between Er:YAG AFL-PDT and MAL-PDT

  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

Study Arms (2)

Er:YAG AFL-PDT

EXPERIMENTAL

AFL was performed using a 2940-nm Er:YAG ablative fractional laser (Joule, Sciton Inc., CA, UA) at 550-600 µm ablation in depth, level 1 coagulation, 22% treatment density, and a single pulse. Immediately afterwards, a 1-mm thick layer of MAL (16% Metvix® cream, PhotoCure ASA, Oslo, Norway) was applied to the lesion and to 5 mm of surrounding healthy tissue. The area was covered with an occlusive dressing (Tegaderm, 3M, Saint Paul, MN, US) for 3 hours, after which the remaining cream was removed with saline gauze, and the red fluorescence of porphyrins was visualized with Wood's light. Each treatment area was then separately illuminated with red light-emitting diode (LED) lamps (Aktilite CL128; Galderma, Bruchsal, Germany) with peak emission at 632 nm and total light dose of 37 J cm2.

Procedure: Er:YAG AFL-PDT

MAL-PDT

ACTIVE COMPARATOR

Immediately afterwards, a 1-mm thick layer of MAL (16% Metvix® cream, PhotoCure ASA, Oslo, Norway) was applied to the lesion and to 5 mm of surrounding healthy tissue. The area was covered with an occlusive dressing (Tegaderm, 3M, Saint Paul, MN, US) for 3 hours, after which the remaining cream was removed with saline gauze, and the red fluorescence of porphyrins was visualized with Wood's light. Each treatment area was then separately illuminated with red light-emitting diode (LED) lamps (Aktilite CL128; Galderma, Bruchsal, Germany) with peak emission at 632 nm and total light dose of 37 J cm2. Areas which were scheduled to receive MAL-PDT received the second treatment 7 days later.

Procedure: MAL-PDT

Interventions

Er:YAG AFL-PDT PROCEDURE

AFL was performed using a 2940-nm Er:YAG ablative fractional laser (Joule, Sciton Inc., CA, UA) at 550-600 µm ablation in depth, level 1 coagulation, 22% treatment density, and a single pulse. Immediately afterwards, a 1-mm thick layer of MAL (16% Metvix® cream, PhotoCure ASA, Oslo, Norway) was applied to the lesion and to 5 mm of surrounding healthy tissue. The area was covered with an occlusive dressing (Tegaderm, 3M, Saint Paul, MN, US) for 3 hours, after which the remaining cream was removed with saline gauze, and the red fluorescence of porphyrins was visualized with Wood's light. Each treatment area was then separately illuminated with red light-emitting diode (LED) lamps (Aktilite CL128; Galderma, Bruchsal, Germany) with peak emission at 632 nm and total light dose of 37 J cm2.

Er:YAG AFL-PDT

MAL-PDT PROCEDURE

a 1-mm thick layer of MAL (16% Metvix® cream, PhotoCure ASA, Oslo, Norway) was applied to the lesion and to 5 mm of surrounding healthy tissue. The area was covered with an occlusive dressing (Tegaderm, 3M, Saint Paul, MN, US) for 3 hours, after which the remaining cream was removed with saline gauze, and the red fluorescence of porphyrins was visualized with Wood's light. Each treatment area was then separately illuminated with red light-emitting diode (LED) lamps (Aktilite CL128; Galderma, Bruchsal, Germany) with peak emission at 632 nm and total light dose of 37 J cm2. Areas which were scheduled to receive MAL-PDT received the second treatment 7 days later.

MAL-PDT

Eligibility Criteria

• Age: 38 Years - 78 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dong-A University: lead

Study Sites (1)

Dong-A University

Busan, Seo-gu, 602-715, South Korea

Location

Study Officials

• Ki-Hoon Song, M.D., Ph.D.

  Dong-A University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor and chairman, Department of dermatology Dong-A University, College of medicine

Study Record Dates

• First Submitted: November 29, 2013
• First Posted: December 23, 2013
• Study Start: March 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: September 1, 2013
• Last Updated: December 23, 2013

Record last verified: 2013-12

Locations

KR (1)