NCT03068208

Brief Summary

Efficacy of Methylene blue mediated Photodynamic therapy for primary localized cutaneous amyloidosis treatment in Asians, pilot study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

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
5.2 years until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

12 months

First QC Date

February 20, 2017

Last Update Submit

May 9, 2026

Conditions

Lichen Amyloidosis

Keywords

Methylene bluephotodynamic therapyprimary cutaneous localized amyloidosislichen amyloidosis

Outcome Measures

Primary Outcomes (1)

  • Roughness evaluation by using visioscan

    The improvement of roughness during the treatment

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

Study Arms (2)

MB-PDT

EXPERIMENTAL
Procedure: Methylene blue-mediated photodynamic therapy

Control

NO INTERVENTION

Interventions

Methylene blue-mediated photodynamic therapyPROCEDURE

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)

MB-PDT

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 pathological findings.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Chulalongkorn Memorial Hospital

Bangkok, Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Amyloidosis, Primary Cutaneous

Study Officials

  • Einapak Amnarttrakul, M.D.

    Chulalongkorn University

    PRINCIPAL INVESTIGATOR

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
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

February 20, 2017

First Posted

March 1, 2017

Study Start

May 1, 2022

Primary Completion

April 30, 2023

Study Completion

June 30, 2023

Last Updated

May 13, 2026

Record last verified: 2026-05

Locations

TH(1)