Back to resultsEfficacy of Methylene Blue Mediated Photodynamic Therapy for Primary Localized Cutaneous Amyloidosis Treatment in Asians
Primary Purpose
Lichen Amyloidosis
Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Methylene blue-mediated photodynamic therapy
Sponsored by
About this trial
This is an interventional treatment trial for Lichen Amyloidosis focused on measuring Methylene blue, photodynamic therapy, primary cutaneous localized amyloidosis, lichen amyloidosis
Eligibility Criteria
Inclusion Criteria:
- Patients, aged > 18 years old with lichen amyloidosis diagnosed by using clinical presentation and pathological findings.
Exclusion Criteria:
- Those with systemic disease associated cutaneous amyloidosis
- Pregnancy or lactating woman
- Those who are allergic to urea, olive oil
- Those who are photosensitive to ultraviolet radiation
- Those who had been previously treated with any of which -medications, radiation, laser within 3 months and 1 month for topical therapy
Sites / Locations
- King Chulalongkorn Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
MB-PDT
Control
Arm Description
Outcomes
Primary Outcome Measures
Roughness evaluation by using visioscan
The improvement of roughness during the treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT03068208
First Posted
February 20, 2017
Last Updated
February 26, 2017
Sponsor
Chulalongkorn University
1. Study Identification
Unique Protocol Identification Number
NCT03068208
Brief Title
Efficacy of Methylene Blue Mediated Photodynamic Therapy for Primary Localized Cutaneous Amyloidosis Treatment in Asians
Official Title
Efficacy of Methylene Blue Mediated Photodynamic Therapy for Primary Localized Cutaneous Amyloidosis Treatment in Asians: Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2017 (Anticipated)
Primary Completion Date
April 30, 2018 (Anticipated)
Study Completion Date
June 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chulalongkorn University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Efficacy of Methylene blue mediated Photodynamic therapy for primary localized cutaneous amyloidosis treatment in Asians, pilot study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lichen Amyloidosis
Keywords
Methylene blue, photodynamic therapy, primary cutaneous localized amyloidosis, lichen amyloidosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MB-PDT
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Methylene blue-mediated photodynamic therapy
Intervention Description
The 2% MB aqueous solution was applied to the lesion until saturation occurred, followed by a occlusive dressing and rest period of 30 minutes. After the rest period, the lesion was immediately illuminated with incoherent red light (peak emission spectrum at 630-640 nm)
Primary Outcome Measure Information:
Title
Roughness evaluation by using visioscan
Description
The improvement of roughness during the treatment
Time Frame
Change from baseline roughness at every 2 weeks up to 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients, aged > 18 years old with lichen amyloidosis diagnosed by using clinical presentation and pathological findings.
Exclusion Criteria:
Those with systemic disease associated cutaneous amyloidosis
Pregnancy or lactating woman
Those who are allergic to urea, olive oil
Those who are photosensitive to ultraviolet radiation
Those who had been previously treated with any of which -medications, radiation, laser within 3 months and 1 month for topical therapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Einapak Amnarttrakul, M.D.
Phone
7521182743
Email
einapak.b@chula.ac.th
First Name & Middle Initial & Last Name or Official Title & Degree
Pravit Asawanonda, M.D., PhD
Phone
66818129393
Email
pravit.a@chula.ac.th, fibrosis@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Einapak Amnarttrakul, M.D.
Organizational Affiliation
Chulalongkorn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anukorn Sriaram, B.Eng.
Phone
66860645757
Email
photochulateam@gmail.com
First Name & Middle Initial & Last Name & Degree
Jaruwan Pemcharoen, B.Sc.
Phone
66823573912
Email
photochulateam@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy of Methylene Blue Mediated Photodynamic Therapy for Primary Localized Cutaneous Amyloidosis Treatment in Asians
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