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

NCT ID: NCT03068208

Last Updated: 2017-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-06-30

Brief Summary

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

Detailed Description

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Conditions

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Lichen Amyloidosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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MB-PDT

Group Type EXPERIMENTAL

Methylene blue-mediated photodynamic therapy

Intervention Type 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)

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Einapak Amnarttrakul, M.D.

Role: PRINCIPAL_INVESTIGATOR

Chulalongkorn University

Locations

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King Chulalongkorn Memorial Hospital

Bangkok, Bangkok, Thailand

Site Status

Countries

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Thailand

Central Contacts

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Einapak Amnarttrakul, M.D.

Role: CONTACT

7521182743

Pravit Asawanonda, M.D., PhD

Role: CONTACT

Facility Contacts

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Anukorn Sriaram, B.Eng.

Role: primary

66860645757

Jaruwan Pemcharoen, B.Sc.

Role: backup

66823573912

Other Identifiers

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CU_MBPDT_for_amyloidosis

Identifier Type: -

Identifier Source: org_study_id

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