Unique ID issued by UMIN | UMIN000031721 |
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Receipt number | 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 15:59:38 |
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
ALA-PDT for ulcers infected with MRSA or Pseudomonas aeruginosa
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
ALA-PDT for ulcers infected with MRSA or Pseudomonas aeruginosa
Japan |
Skin ulcers infected with methicillin-resistant Staphylococcus aureus (MRSA), Pseudomonas aeruginosa, or both bacteria.
Dermatology |
Others
NO
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.
Safety,Efficacy
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.
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.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Device,equipment | Maneuver |
Patients will receive treatment with ALA ointment and 410 nm LED photodynamic therapy for skin ulcers infected by MRSA, Pseudomonas aeruginosa, or both bacteria.
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
12
1st name | |
Middle name | |
Last name | Toshiyuki Ozawa |
Osaka city university hospital
Department of dermatorogy
545-8586 1-4-3asahi-machi ,abeno-ku,osaka city,osaka,Japan
06-6645-3826
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1st name | |
Middle name | |
Last name | Toshiyuki Ozawa |
Osaka city university hospital
Department of dermatorogy
545-8586 1-4-3asahi-machi ,abeno-ku,osaka city,osaka,Japan
06-6645-3826
http://www.med.osaka-cu.ac.jp/Derma/
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Osaka City University Graduate school of Medicine
Osaka City University Graduate school of Medicine
Self funding
NO
2018 | Year | 03 | Month | 14 | Day |
Unpublished
Open public recruiting
2018 | Year | 01 | Month | 30 | Day |
2018 | Year | 03 | Month | 14 | Day |
2018 | Year | 03 | Month | 14 | Day |
2018 | Year | 03 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036086
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