Lichen AmyloidosisNCT03068208
Efficacy of Methylene Blue Mediated Photodynamic Therapy for Primary Localized Cutaneous Amyloidosis Treatment in Asians
A study testing Methylene blue-mediated photodynamic therapy in people with Lichen Amyloidosis, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
Efficacy of Methylene blue mediated Photodynamic therapy for primary localized cutaneous amyloidosis treatment in Asians, pilot study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lichen Amyloidosis
- What is being tested?
- Methylene blue-mediated photodynamic therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteThailand
- Study dates
- 1 May 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients, aged > 18 years old with lichen amyloidosis diagnosed by using clinical presentation and pathological findings.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Methylene Blue Mediated Photodynamic Therapy for Primary Localized Cutaneous Amyloidosis Treatment in Asians: Pilot Study
Efficacy of Methylene blue mediated Photodynamic therapy for primary localized cutaneous amyloidosis treatment in Asians, pilot study.
- Conditions
- Lichen Amyloidosis
- Being tested
- Methylene blue-mediated photodynamic therapy
- Keywords
- Methylene blue, photodynamic therapy, primary cutaneous localized amyloidosis, lichen amyloidosis
- Medical subject headings
- Amyloidosis, Primary Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylene blue-mediated photodynamic therapyProcedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| MB-PDT | Experimental | Not described Receives: Procedure: Methylene blue-mediated photodynamic therapy |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Roughness evaluation by using visioscan
The improvement of roughness during the treatment
Measured: Change from baseline roughness at every 2 weeks up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start1 May 2022
- Primary completion30 Apr 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lichen AmyloidosisStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Einapak Boontaveeyuwat, MD, Chulalongkorn University
- Investigators
- Einapak Amnarttrakul, M.D., Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068208
- Sponsor's protocol ID
- CU_MBPDT_for_amyloidosis
- Status last verified
- May 2026
- First submitted
- 20 Feb 2017
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Methylene Blue Mediated Photodynamic Therapy for Primary Localized Cutaneous Amyloidosis Treatment in Asians: Pilot Study
- ClinicalTrials.gov ID
- NCT03068208
- Acronym / sponsor ID
- CU_MBPDT_for_amyloidosis
- Conditions
- Lichen Amyloidosis
- Keywords
- Methylene blue, photodynamic therapy, primary cutaneous localized amyloidosis, lichen amyloidosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 1 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Efficacy of Methylene blue mediated Photodynamic therapy for primary localized cutaneous amyloidosis treatment in Asians, pilot study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MB-PDT | Experimental | Procedure: Methylene blue-mediated photodynamic therapy |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients, aged > 18 years old with lichen amyloidosis diagnosed by using clinical presentation and pathological findings.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylene blue-mediated photodynamic therapyThe 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) | Procedure or surgery | MB-PDT |
Primary outcome
Roughness evaluation by using visioscan
Time frame: Change from baseline roughness at every 2 weeks up to 16 weeks
The improvement of roughness during the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Lichen Amyloidosis
Not yet recruiting
Efficacy and Safety of Stapokibart for Primary Cutaneous Amyloidosis
Primary Cutaneous Amyloidosis
RecruitingPhase 4
A Prospective Cohort Study on Primary Cutaneous Amyloidosis
Primary Cutaneous Amyloidosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Einapak Amnarttrakul, M.D. principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methylene blue-mediated photodynamic therapy in people with Lichen Amyloidosis, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Roughness evaluation by using visioscan (time frame: Change from baseline roughness at every 2 weeks up to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.