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

Lichen Amyloidosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03068156
• Other study ID #: CU_308excimer_amyloidosis
• Status: Recruiting
• Phase: N/A
• First received: February 20, 2017
• Last updated: February 26, 2017
• Start date: January 31, 2017
• Est. completion date: March 2, 2018

Study information

• Verified date: February 2017
• Source: Chulalongkorn University
• Contact: Einapak Amnarttrakul, M.D.
• Phone: 7521182743
• Email: einapak.b[@]chula.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: March 2, 2018
• Est. primary completion date: January 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyloidosis
• Amyloidosis, Familial
• Lichen Amyloidosis
• Skin Diseases, Genetic

Intervention

Radiation:
• 308-nm excimer laser
monochromator UVB laser (308nm)

Locations

Country	Name	City	State
Thailand	King Chulalongkorn Memorial Hospital	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Chulalongkorn University	Ratchadapiseksompotch Fund

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Roughness evaluation by using Visioscan® VC98	The improvement of roughness evaluation	Change from baseline roughness at every 2 weeks up to 16 weeks