Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov 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
Sponsor:
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

Layout table for study information
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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): NCT03068208


Contacts
Layout table for location contacts
Contact: Einapak Amnarttrakul, M.D. 7521182743 einapak.b@chula.ac.th
Contact: Pravit Asawanonda, M.D., PhD 66818129393 pravit.a@chula.ac.th, fibrosis@gmail.com

Locations
Layout table for location information
Thailand
King Chulalongkorn Memorial Hospital Not yet recruiting
Bangkok, Thailand, 10330
Contact: Anukorn Sriaram, B.Eng.    66860645757    photochulateam@gmail.com   
Contact: Jaruwan Pemcharoen, B.Sc.    66823573912    photochulateam@gmail.com   
Sponsors and Collaborators
Chulalongkorn University
Investigators
Layout table for investigator information
Principal Investigator: Einapak Amnarttrakul, M.D. Chulalongkorn University

Layout table for additonal information
Responsible Party: Chulalongkorn University
ClinicalTrials.gov Identifier: NCT03068208     History of Changes
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

Layout table for additional information
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:
Layout table for MeSH terms
Amyloidosis
Skin Diseases, Genetic
Amyloidosis, Familial
Proteostasis Deficiencies
Metabolic Diseases
Genetic Diseases, Inborn
Skin Diseases
Metabolism, Inborn Errors
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action