- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02018679
Er:YAG Ablative Fractional Laser Assisted-Photodynamic Therapy Versus Photodynamic Therapy for Basal Cell Carcinoma
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Seo-gu
-
Busan, Seo-gu, Korea, Republic of, 602-715
- Dong-A University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Efficacy was evaluated at 3 months and 12 months after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Cosmetic outcome was assessed by each investigator for all lesions that achieved a complete response at 3 or 12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
recurrence rates were evaluated at 12 months after the last treatment.
|
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.). |
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ki-Hoon Song, M.D., Ph.D., Dong-A University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DAUDerma-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Nodular Basal Cell Carcinoma
-
Maastricht University Medical CenterActive, not recruitingNodular Basal Cell CarcinomaNetherlands
-
Spirig Pharma Ltd.TerminatedNodular Basal Cell CarcinomaGermany, Switzerland
-
MediWound LtdRecruitingNodular Basal Cell Carcinoma | Superficial Basal Cell CarcinomaUnited States
-
University of MiamiCompletedNodular Basal Cell Carcinoma | Superficial Basal Cell CarcinomaUnited States
-
Christopher ZacharyRecruitingBasal Cell Carcinoma | Nodular Basal Cell Carcinoma | Superficial Basal Cell CarcinomaUnited States
-
Memorial Sloan Kettering Cancer CenterActive, not recruitingBasal Cell Carcinoma | Nodular Basal Cell Carcinoma | Superficial Basal Cell Carcinoma | BCC | BCC - Basal Cell Carcinoma | Basal Cell CancerUnited States
-
AiViva BioPharma, Inc.CompletedNodular Basal Cell Carcinoma | Superficial Basal Cell CarcinomaUnited States
-
Novartis PharmaceuticalsTerminatedSporadic Superficial and Nodular Skin Basal Cell CarcinomasAustria, Australia
-
Ascend Biopharmaceuticals LtdCompletedBasal Cell Nevus Syndrome | Skin Neoplasm | Nodular Basal Cell Carcinoma of SkinAustralia
-
University Hospital, BordeauxCompletedLocally Advanced Basal Cell Carcinoma | Metastatic Basal Cell CarcinomaFrance
Clinical Trials on Er:YAG AFL-PDT
-
Dong-A UniversityCompletedBowen's DiseaseKorea, Republic of
-
Dong-A UniversityCompletedActinic CheilitisKorea, Republic of
-
Dong-A UniversityCompletedActinic KeratosisKorea, Republic of
-
San Diego State UniversityArizona State UniversityCompletedPhysical Activity | Cardiovascular FitnessUnited States
-
University of MiamiWithdrawn
-
Rambam Health Care CampusCompleted
-
Damascus UniversityCompletedClass II Division 1 Malocclusion | Protrusion, Incisor | Maxillary PrognathismSyrian Arab Republic
-
University Hospital Inselspital, BerneWithdrawnLupus Erythematosus, CutaneousSwitzerland
-
University Of PerugiaCompletedDental Caries | Microbial ColonizationItaly