Efficacy of Methylene Blue Mediated Photodynamic Therapy for Primary Localized Cutaneous Amyloidosis Treatment in Asians

Lichen Amyloidosis Clinical Trial

Official title:

Efficacy of Methylene Blue Mediated Photodynamic Therapy for Primary Localized Cutaneous Amyloidosis Treatment in Asians: Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03068208
• Other study ID #: CU_MBPDT_for_amyloidosis
• Status: Not yet recruiting
• Phase: N/A
• First received: February 20, 2017
• Last updated: February 26, 2017
• Start date: May 1, 2017
• Est. completion date: June 30, 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 Methylene blue mediated Photodynamic therapy for primary localized cutaneous amyloidosis treatment in Asians, pilot study.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: June 30, 2018
• Est. primary completion date: April 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 pathological findings.

Exclusion Criteria:

• Those with systemic disease associated cutaneous amyloidosis

• 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 any of which -medications, radiation, laser within 3 months and 1 month for topical therapy

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Methylene blue-mediated photodynamic therapy
The 2% MB aqueous solution was applied to the lesion until saturation occurred, followed by a occlusive dressing and rest period of 30 minutes. After the rest period, the lesion was immediately illuminated with incoherent red light (peak emission spectrum at 630-640 nm)

Locations

Country	Name	City	State
Thailand	King Chulalongkorn Memorial Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Roughness evaluation by using visioscan	The improvement of roughness during the treatment	Change from baseline roughness at every 2 weeks up to 16 weeks