UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061085 |
|---|---|
| Receipt number | R000069897 |
| Scientific Title | Evaluating the real-world effectiveness of a pyroxylin-based liquid bandage for treatment of superficial abrasion wounds: a randomized, self-controlled trial |
| Date of disclosure of the study information | 2026/03/27 |
| Last modified on | 2026/03/27 15:40:10 |
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Basic information
Public title
Study on the Effectiveness of a Liquid Bandage for Minor Skin Abrasions
Acronym
Liquid Bandage Study
Scientific Title
Evaluating the real-world effectiveness of a pyroxylin-based liquid bandage for treatment of superficial abrasion wounds: a randomized, self-controlled trial
Scientific Title:Acronym
SWIFT Heal Study
Region
| Asia(except Japan) |
Condition
Condition
Superficial abrasion wounds
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the real-world effectiveness of liquid bandage compared to adhesive bandage in promoting wound healing among consumers with superficial wounds.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Wound area
Key secondary outcomes
Scar quality
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
In this randomized, self-controlled trial, participants with at least two superficial abrasion wounds (1-3 cm) on opposite sides of the body receive two treatments. One wound is treated with a pyroxylin-based liquid bandage, and the contralateral wound is treated with a conventional adhesive bandage with a wound pad as a control. The healing process is evaluated and compared between the two sites over a 30-day period.
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
| 21 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy males and females aged between 21 and 64 years old.
2. Have 2 or more abrasions that occurred within one day (equivalent to Stage I of StatPearls Wound Assessment), with at least one on each side of the upper or lower extremities.
3. Have a fresh superficial wound with a wound surface area of 1-3 cm (inclusive) in diameter (corresponding to an area of 0.79-7.07cm2). Wounds need to have a moist surface, with no visible bleeding or mild visible bleeding, and not yet have formed a crust or scab.
4. Recommended to use liquid bandage or adhesive bandage as per routine clinical practice.
Key exclusion criteria
1. Individuals suffering from or currently being treated for serious diseases such as diabetes, cancer, kidney disease, liver disease, thyroid disease, adrenal disease, or metabolic diseases that may significantly affect the healing process, or those with a history of such conditions.
2. Individuals suffering from or currently being treated for chronic bedsores, immune disorders, infections that may affect the healing process, or those with a history of such conditions.
3. Individuals who routinely consume collagen peptides.
4. Individuals with Fitzpatrick Classification skin types V - VI (due to higher susceptibility to keloids and hypertrophic scars).
5. Individuals with acne, sunburn, eczema, scars, excessive hair, acute skin infections, hyperpigmentation, hypopigmentation, or tattoos near the target wound.
6. Pregnant or breastfeeding individuals, those who may be pregnant, or those planning to become pregnant.
7. Individuals currently participating in, or who have participated in, clinical trials related to wound care or wound healing within the past 3 months.
8. Individual deemed unsuitable for this study by the Principal Investigator.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Eng Chun |
| Middle name | |
| Last name | Tan |
Organization
EJ Family Clinic & Surgery Blk
Division name
None
Zip code
310109
Address
109 Toa Payoh Lorong 1, #01-314 Singapore
TEL
+6262778272
drectan2@gmail.com
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Kajiyama |
Organization
KOBAYASHI Pharmaceutical Co., Ltd.
Division name
Life Science Research Department R&D Headquarters
Zip code
567-0057
Address
1-30-3, Toyokawa, Ibaraki-city, Osaka 567-0057 Japan
TEL
072-640-0121
Homepage URL
s.kajiyama@kobayshi.co.jp
Sponsor or person
Institute
KOBAYASHI Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
KOBAYASHI Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Parkway Independent Ethics Committee (PIEC)
Address
HarbourFront Tower One 1 HarbourFront Place #03-02 Singapore 098633
Tel
+65 6277 8272
piec@ihhhealthcare.com
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
| 2026 | Year | 03 | Month | 27 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 27 | Day |
Last modified on
| 2026 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069897
