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

February 26, 2017 updated by: Chulalongkorn University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Recruiting
        • King Chulalongkorn Memorial Hospital
        • Sub-Investigator:
          • Pawinee Rerknimitr, M.D.
        • Sub-Investigator:
          • Chanat Kumtornrat, M.D.
        • Sub-Investigator:
          • Kitipong Wantavornprasert, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
EXPERIMENTAL: excimer laser
Radiation: 308-nm excimer laser
monochromator UVB laser (308nm)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline roughness at every 2 weeks up to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Collaborators

Ratchadapiseksompotch Fund

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 31, 2017

Primary Completion (ANTICIPATED)

January 30, 2018

Study Completion (ANTICIPATED)

March 2, 2018

Study Registration Dates

First Submitted

February 20, 2017

First Submitted That Met QC Criteria

February 26, 2017

First Posted (ACTUAL)

March 1, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 1, 2017

Last Update Submitted That Met QC Criteria

February 26, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CU_308excimer_amyloidosis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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