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Efficacy of Methylene Blue Mediated Photodynamic Therapy for Primary Localized Cutaneous Amyloidosis Treatment in Asians

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03068208
Recruitment Status : Unknown
Verified February 2017 by Chulalongkorn University.
Recruitment status was:  Not yet recruiting
First Posted : March 1, 2017
Last Update Posted : March 1, 2017
Information provided by (Responsible Party):
Chulalongkorn University

Brief Summary:
Efficacy of Methylene blue mediated Photodynamic therapy for primary localized cutaneous amyloidosis treatment in Asians, pilot study.

Condition or disease Intervention/treatment Phase
Lichen Amyloidosis Procedure: Methylene blue-mediated photodynamic therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Methylene Blue Mediated Photodynamic Therapy for Primary Localized Cutaneous Amyloidosis Treatment in Asians: Pilot Study
Estimated Study Start Date : May 1, 2017
Estimated Primary Completion Date : April 30, 2018
Estimated Study Completion Date : June 30, 2018

Arm Intervention/treatment
Experimental: MB-PDT Procedure: Methylene blue-mediated photodynamic therapy
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)

No Intervention: Control

Primary Outcome Measures :
  1. Roughness evaluation by using visioscan [ Time Frame: Change from baseline roughness at every 2 weeks up to 16 weeks ]
    The improvement of roughness during the treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT03068208

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Contact: Einapak Amnarttrakul, M.D. 7521182743
Contact: Pravit Asawanonda, M.D., PhD 66818129393,

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King Chulalongkorn Memorial Hospital
Bangkok, Thailand, 10330
Contact: Anukorn Sriaram, B.Eng.    66860645757   
Contact: Jaruwan Pemcharoen, B.Sc.    66823573912   
Sponsors and Collaborators
Chulalongkorn University
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Principal Investigator: Einapak Amnarttrakul, M.D. Chulalongkorn University
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Responsible Party: Chulalongkorn University Identifier: NCT03068208    
Other Study ID Numbers: CU_MBPDT_for_amyloidosis
First Posted: March 1, 2017    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chulalongkorn University:
Methylene blue
photodynamic therapy
primary cutaneous localized amyloidosis
lichen amyloidosis
Additional relevant MeSH terms:
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Proteostasis Deficiencies
Metabolic Diseases
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action