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Efficacy of 308-nm Excimer Laser 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: NCT03068156
Recruitment Status : Unknown
Verified February 2017 by Chulalongkorn University.
Recruitment status was:  Recruiting
First Posted : March 1, 2017
Last Update Posted : March 1, 2017
Sponsor:
Collaborator:
Ratchadapiseksompotch Fund
Information provided by (Responsible Party):
Chulalongkorn University

Brief Summary:
Efficacy of 308-nm excimer laser for primary localized cutaneous amyloidosis treatment in Asians, pilot study.

Condition or disease Intervention/treatment Phase
Lichen Amyloidosis Radiation: 308-nm excimer laser 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 308-nm Excimer Laser for Primary Localized Cutaneous Amyloidosis Treatment in Asians: Pilot Study
Actual Study Start Date : January 31, 2017
Estimated Primary Completion Date : January 30, 2018
Estimated Study Completion Date : March 2, 2018


Arm Intervention/treatment
Experimental: excimer laser Radiation: 308-nm excimer laser
monochromator UVB laser (308nm)

No Intervention: Control



Primary Outcome Measures :
  1. Roughness evaluation by using Visioscan® VC98 [ Time Frame: Change from baseline roughness at every 2 weeks up to 16 weeks ]
    The improvement of roughness evaluation



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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 pathologic features

Exclusion Criteria:

  • Those with cutaneous amyloidosis associated systemic diseases
  • 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 medications/ radiation/ laser within 3 months for systemic 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): NCT03068156


Contacts
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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
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Thailand
King Chulalongkorn Memorial Hospital Recruiting
Bangkok, Thailand, 10330
Contact: Anukorn Sriaram, B.Eng.    66860645757    photochulateam@gmail.com   
Contact: Jaruwan Pemcharoen, B.Sc.    66823573912    photochulateam@gmail.com   
Sub-Investigator: Pawinee Rerknimitr, M.D.         
Sub-Investigator: Chanat Kumtornrat, M.D.         
Sub-Investigator: Kitipong Wantavornprasert, M.D.         
Sponsors and Collaborators
Chulalongkorn University
Ratchadapiseksompotch Fund
Investigators
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Principal Investigator: Einapak Amnarttrakul, M.D. Chulalongkorn University
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Responsible Party: Chulalongkorn University
ClinicalTrials.gov Identifier: NCT03068156    
Other Study ID Numbers: CU_308excimer_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
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Chulalongkorn University:
308-nm excimer laser
primary localized cutaneous amyloidosis
lichen amyloidosis
Asians
Additional relevant MeSH terms:
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Skin Diseases, Genetic
Amyloidosis, Familial
Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases
Genetic Diseases, Inborn
Skin Diseases
Metabolism, Inborn Errors