Efficacy of Methylene Blue Mediated Photodynamic Therapy... | NCT03068208

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

NCT03068208

Sponsor

Chulalongkorn University

Status

Completed

Last Update Posted

May 13, 2026Actual

Enrollment

15Actual

Phase

Not Applicable

Conditions

Lichen Amyloidosis

Interventions

Methylene blue-mediated photodynamic therapy

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2022Actual

Primary Completion Date

Apr 30, 2023Actual

Completion Date

Jun 30, 2023Actual

First Submitted Date

Feb 20, 2017

First Submission Date that Met QC Criteria

Feb 26, 2017

First Posted Date

Mar 1, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 9, 2026

Last Update Posted Date

May 13, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MB-PDT	Experimental		Procedure: Methylene blue-mediated photodynamic therapy
Control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Methylene blue-mediated photodynamic therapy	Procedure	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)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Einapak Amnarttrakul, M.D.	Chulalongkorn University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
King Chulalongkorn Memorial Hospital		Bangkok	Bangkok	10330	Thailand

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
C562642	Amyloidosis, Primary Cutaneous

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided