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Trial record 9 of 24 for:    Porphyrins

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

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ClinicalTrials.gov Identifier: NCT02018679
Recruitment Status : Completed
First Posted : December 23, 2013
Last Update Posted : December 23, 2013
Sponsor:
Information provided by (Responsible Party):
Song Ki-Hoon, Dong-A University

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.

Condition or disease Intervention/treatment Phase
Nodular Basal Cell Carcinoma Procedure: Er:YAG AFL-PDT Procedure: MAL-PDT Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : March 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : September 2013

Arm Intervention/treatment
Experimental: Er:YAG AFL-PDT
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
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.

Active Comparator: MAL-PDT
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
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.




Primary Outcome Measures :
  1. Difference the efficacy between Er:YAG AFL-PDT and MAL-PDT [ Time Frame: Efficacy was evaluated at 3 months and 12 months after treatment ]
    Lesion responses were classified as either a complete response (complete disappearance of the lesion) or a non-complete response (incomplete disappearance)


Secondary Outcome Measures :
  1. Difference of the cosmetic outcomes between Er:YAG AFL-PDT and MAL-PDT treatment [ Time Frame: Cosmetic outcome was assessed by each investigator for all lesions that achieved a complete response at 3 or 12 months ]
    I 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)


Other Outcome Measures:
  1. Difference of the recurrence rates between Er:YAG AFL-PDT and MAL-PDT [ Time Frame: recurrence rates were evaluated at 12 months after the last treatment. ]
    In all cases of complete response, the patients were reviewed at 12 months to check for recurrence. Recurrence was assessed by inspection, dermoscopy, photography, palpation, and histologic findings.

  2. Difference of the safety between Er:YAG AFL-PDT and MAL-PDT [ Time Frame: 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 ]

    Adverse events reported by the patient were noted at each follow-up visit, including severity, duration, and need for additional treatment.

    The severity of the adverse event was assessed as follows: mild (transient and easily tolerated); moderate (caused the patient discomfort and interrupted usual activities); and severe (caused considerable interference with usual activities and may have been incapacitating or life threatening).

    All adverse events due to PDT were described as phototoxic reactions (i.e. erythema, postinflammatory hyperpigmentation, edema, itching, oozing, bleeding, etc.).




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Ages Eligible for Study:   38 Years to 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02018679


Locations
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Korea, Republic of
Dong-A University
Busan, Seo-gu, Korea, Republic of, 602-715
Sponsors and Collaborators
Dong-A University
Investigators
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Study Chair: Ki-Hoon Song, M.D., Ph.D. Dong-A University

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Responsible Party: Song Ki-Hoon, Assistant professor and chairman, Department of dermatology Dong-A University, College of medicine, Dong-A University
ClinicalTrials.gov Identifier: NCT02018679     History of Changes
Other Study ID Numbers: DAUDerma-02
First Posted: December 23, 2013    Key Record Dates
Last Update Posted: December 23, 2013
Last Verified: December 2013

Keywords provided by Song Ki-Hoon, Dong-A University:
Nodular basal cell carcinoma
Er:YAG
AFL-assisted
MAL-PDT

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Methyl 5-aminolevulinate
Photosensitizing Agents
Dermatologic Agents