NCT03068156

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2017

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2018

Completed
Last Updated

March 1, 2017

Status Verified

February 1, 2017

Enrollment Period

12 months

First QC Date

February 20, 2017

Last Update Submit

February 26, 2017

Conditions

Lichen Amyloidosis

Keywords

308-nm excimer laserprimary localized cutaneous amyloidosislichen amyloidosisAsians

Outcome Measures

Primary Outcomes (1)

  • Roughness evaluation by using Visioscan® VC98

    The improvement of roughness evaluation

    Change from baseline roughness at every 2 weeks up to 16 weeks

Study Arms (2)

excimer laser

EXPERIMENTAL
Radiation: 308-nm excimer laser

Control

NO INTERVENTION

Interventions

308-nm excimer laserRADIATION

monochromator UVB laser (308nm)

excimer laser

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients, aged \>18 years old with lichen amyloidosis diagnosed by using clinical presentation and pathologic features

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Chulalongkorn Memorial Hospital

Bangkok, Bangkok, 10330, Thailand

RECRUITING

MeSH Terms

Conditions

Amyloidosis, Primary Cutaneous

Interventions

Lasers, Excimer

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Einapak Amnarttrakul, M.D.

    Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Einapak Amnarttrakul, M.D.

CONTACT

7521182743einapak.b@chula.ac.th

Pravit Asawanonda, M.D., PhD

CONTACT

66818129393pravit.a@chula.ac.th, fibrosis@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2017

First Posted

March 1, 2017

Study Start

January 31, 2017

Primary Completion

January 30, 2018

Study Completion

March 2, 2018

Last Updated

March 1, 2017

Record last verified: 2017-02

Locations

TH(1)