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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031721
Receipt No. R000036086
Scientific Title Study of 5-aminolevulinic acid ointment and 410 nm LED photodynamic therapy for treatment of skin ulcers infected with methicillin-resistant Staphylococcus aureus, Pseudomonas aeruginosa, or both bacteria
Date of disclosure of the study information 2018/03/14
Last modified on 2018/03/14

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Basic information
Public title Study of 5-aminolevulinic acid ointment and 410 nm LED photodynamic therapy for treatment of skin ulcers infected with methicillin-resistant Staphylococcus aureus, Pseudomonas aeruginosa, or both bacteria
Acronym ALA-PDT for ulcers infected with MRSA or Pseudomonas aeruginosa
Scientific Title Study of 5-aminolevulinic acid ointment and 410 nm LED photodynamic therapy for treatment of skin ulcers infected with methicillin-resistant Staphylococcus aureus, Pseudomonas aeruginosa, or both bacteria
Scientific Title:Acronym ALA-PDT for ulcers infected with MRSA or Pseudomonas aeruginosa
Region
Japan

Condition
Condition Skin ulcers infected with methicillin-resistant Staphylococcus aureus (MRSA), Pseudomonas aeruginosa, or both bacteria.
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In patients who have skin ulcers infected by MRSA, Pseudomonas aeruginosa, or both bacteria, treatment with 5-aminolevulinic acid (ALA) ointment and 410 nm LED photodynamic therapy will be conducted to evaluate its efficacy and safety.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall assessment of safety will be conducted on the basis of laboratory test results and adverse events, and a rating will be assigned on the following 4-item scale:
1. Completely safe, 2. Almost safe, 3. Possibly unsafe, 4. Unsafe
Assessment of clinical data and lesion photographs will be performed independently by 3 dermatologists in a blinded manner. If the 3 dermatologists do not agree about an assessment, it will be determined through deliberation. If the rating is 1 or 2 above in more over 80% of the patients, it will be concluded that the treatment is safe.
Key secondary outcomes 1) clinical assessment of ulcers
the following assessment will be conducted at initiation of treatment and every week after initiation. a scale and a color assessment sticker will be placed near each ulcer and photographs will be obtained under the same conditions each time.
・ulcer area (mm2): longer diameter x shorter diameter.・ulcer depth (mm): the deepest site will be measured.
・granulation:・extent of good granulation: ・formation of new epidermis: ・serous secretions: ・purulent secretions:・color of pus:・necrotic tissue: ・severity of infection:
2) bacterial testing
identification of bacterial strains in the ulcers and determination of the colony count will be performed before treatment, in weeks 2 and 4 of treatment, and at the end of treatment. this should also be done in weeks 1 and 3, if possible.
3) improvement of symptoms
improvement of each symptom versus the severity at initiation of treatment will be assessed by using the following 5-item scale:
1. markedly improved, 2. moderately improved, 3. slightly improved, 4. no change, 5. worse
assessment of clinical data and lesion photographs will be performed independently by 3 dermatologists in a blinded manner.
4) assessment of overall efficacy
assessment will be done by using the following 5-item scale:
1. very effective, 2. effective, 3. slightly effective, 4. not effective, 5. worse
assessment of clinical data and lesion photographs will be performed independently by 3 dermatologists in a blinded manner.
5) assessment of usefulness
based on the results for overall efficacy and overall safety, usefulness will be assessed by employing the following 5-item scale:
assessment of data and photographs will be conducted independently by 3 dermatologists.
1. very useful, 2. useful, 3. slightly useful, 4. not useful, 5. harmful
assessment of clinical data and lesion photographs will be performed independently by 3 dermatologists in a blinded manner.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment Maneuver
Interventions/Control_1 Patients will receive treatment with ALA ointment and 410 nm LED photodynamic therapy for skin ulcers infected by MRSA, Pseudomonas aeruginosa, or both bacteria.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who meet all of the following criteria will be eligible for the study.
1) Patients who have a skin ulcer infected with MRSA, Pseudomonas aeruginosa, or both bacteria.
2) Patients aged 20 years or older at the time of giving informed consent.
3) Patients who have bedsores, burn ulcers, or lower limb ulcers with the longer diameter greater than 20 mm and less than or equal to 120 mm.
Each patient should have one ulcer as the study lesion. If a patient has multiple ulcers, one that is considered suitable for this study should be selected and the reason for selection should be recorded.
4) Patients who need hospitalization for treatment of the study lesion.
Key exclusion criteria Patients who meet any of the following criteria will be excluded from the study.
1) Patients with a history of hypersensitivity to ALA ointment or porphyrin.
2) Patients with porphyria.
3) Patients who are using or are expected to receive any of the following drugs known to induce photosensitivity: tetracyclines, sulfonamides, new quinolone, hypericin (Hypericum perforatum extract, etc.), and foods containing Hypericum perforatum (St. John's Wort).
4) Pregnant women, nursing women, and women who plan to become pregnant during the study period.
5) Patients who have received oral or IV antibiotics within 14 days prior to treatment initiation.
6) Patients who are expected to receive antibiotics for greater than 7 days during hospitalization.
In addition, patients who are considered unsuitable for this study by the investigator or subinvestigator (doctor) should be excluded.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiyuki Ozawa
Organization Osaka city university hospital
Division name Department of dermatorogy
Zip code
Address 545-8586 1-4-3asahi-machi ,abeno-ku,osaka city,osaka,Japan
TEL 06-6645-3826
Email aaa@aaa

Public contact
Name of contact person
1st name
Middle name
Last name Toshiyuki Ozawa
Organization Osaka city university hospital
Division name Department of dermatorogy
Zip code
Address 545-8586 1-4-3asahi-machi ,abeno-ku,osaka city,osaka,Japan
TEL 06-6645-3826
Homepage URL http://www.med.osaka-cu.ac.jp/Derma/
Email aaa@aaa

Sponsor
Institute Osaka City University Graduate school of Medicine
Institute
Department

Funding Source
Organization Osaka City University Graduate school of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 14 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 01 Month 30 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 14 Day
Last modified on
2018 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036086

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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