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Efficacy of 308-nm Excimer Laser for Primary Localized Cutaneous Amyloidosis Treatment in Asians

Primary Purpose

Lichen Amyloidosis

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
308-nm excimer laser
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lichen Amyloidosis focused on measuring 308-nm excimer laser, primary localized cutaneous amyloidosis, lichen amyloidosis, Asians

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • King Chulalongkorn Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

excimer laser

Control

Arm Description

Outcomes

Primary Outcome Measures

Roughness evaluation by using Visioscan® VC98
The improvement of roughness evaluation

Secondary Outcome Measures

Full Information

First Posted
February 20, 2017
Last Updated
February 26, 2017
Sponsor
Chulalongkorn University
Collaborators
Ratchadapiseksompotch Fund
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1. Study Identification

Unique Protocol Identification Number
NCT03068156
Brief Title
Efficacy of 308-nm Excimer Laser for Primary Localized Cutaneous Amyloidosis Treatment in Asians
Official Title
Efficacy of 308-nm Excimer Laser 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
January 31, 2017 (Actual)
Primary Completion Date
January 30, 2018 (Anticipated)
Study Completion Date
March 2, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chulalongkorn University
Collaborators
Ratchadapiseksompotch Fund

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Efficacy of 308-nm excimer laser 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
308-nm excimer laser, primary localized cutaneous amyloidosis, lichen amyloidosis, Asians

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
excimer laser
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Radiation
Intervention Name(s)
308-nm excimer laser
Intervention Description
monochromator UVB laser (308nm)
Primary Outcome Measure Information:
Title
Roughness evaluation by using Visioscan® VC98
Description
The improvement of roughness evaluation
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 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
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
Individual Site Status
Recruiting
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
First Name & Middle Initial & Last Name & Degree
Pawinee Rerknimitr, M.D.
First Name & Middle Initial & Last Name & Degree
Chanat Kumtornrat, M.D.
First Name & Middle Initial & Last Name & Degree
Kitipong Wantavornprasert, M.D.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Efficacy of 308-nm Excimer Laser for Primary Localized Cutaneous Amyloidosis Treatment in Asians

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