UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062905 |
|---|---|
| Receipt number | R000071873 |
| Scientific Title | The Efficacy of Dry Wrap Therapy for Pediatric Atopic Dermatitis |
| Date of disclosure of the study information | 2026/09/14 |
| Last modified on | 2026/09/14 08:58:04 |
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Basic information
Public title
Gentle Under-wrap Application for Relief of Dermatitis Study
Acronym
Gentle Under-wrap Application for Relief of Dermatitis Study (GUARD Study)
Scientific Title
The Efficacy of Dry Wrap Therapy for Pediatric Atopic Dermatitis
Scientific Title:Acronym
The Efficacy of Dry Wrap Therapy for Pediatric Atopic Dermatitis (GUARD Study)
Region
| Japan |
Condition
Condition
Atopic Dermatitis
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether adding dry wrap therapy using commercially available bandages to the standard treatment regimen for pediatric patients with atopic dermatitis results in a significant improvement in the severity of atopic dermatitis after 4 weeks, compared with standard treatment alone.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in EASI scores for the limbs from enrollment through 4 weeks
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Dry Wrap Therapy
Interventions/Control_2
Standard Treatment
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
| 1 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Children aged 1 year or older and 15 years or younger who have been diagnosed with atopic dermatitis by a physician according to the UK Working Party criteria.
2. Children who have been receiving appropriate standard anti-inflammatory treatment for atopic dermatitis for at least one month prior to study screening.
3. Children with obvious symptoms of atopic dermatitis on their limbs and a vIGA-AD score of 1 or higher.
4. Children whose parents or guardians are able to ensure compliance with treatment involving ointments and bandaging.
5. Children for whom neither the child nor the parent or guardian has any difficulty understanding Japanese.
6. Children for whom a sufficient written explanation of this study was provided and written informed consent was obtained from a parent, guardian, or other authorized representative of their own free will. Note that for children in elementary school or older, the child's own free will consent is required.
Key exclusion criteria
1. Children with a history of severe skin infections.
2. Children with suspected active localized skin infections (such as cellulitis or impetigo) at the start of the study, or children with concurrent infections requiring systemic administration of antibiotics.
3. Children with serious underlying medical conditions (such as congenital heart disease, severe neuromuscular disorders, or immunodeficiency) for whom the attending physician determines that participation in the study would pose a safety risk.
4. Children for whom the attending physician determines that the application of bandages would increase the absorption rate of the topical medication, thereby raising the risk of adverse reactions.
5. Children for whom regular outpatient visits during the study period are deemed difficult.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Miyamoto |
Organization
Dokkyo Medical University
Division name
Department of Pediatrics
Zip code
321-0293
Address
880, Kita-kobayashi, Mibu-machi, Shimotsuga-gun, Tochigi
TEL
0282-86-1111
manabu-m@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Miyamoto |
Organization
Dokkyo Medical University
Division name
Department of Pediatrics
Zip code
321-0293
Address
880, Kita-kobayashi, Mibu-machi, Shimotsuga-gun, Tochigi
TEL
0282-86-1111
Homepage URL
manabu-m@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board for Clinical Research, Dokkyo Medical University Hospital
Address
880, Kita-kobayashi, Mibu-machi, Shimotsuga-gun, Tochigi
Tel
0282-87-2275
r-kenkyu@dokkyomed.ac.jp
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 | 09 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | 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 | 09 | Month | 14 | Day |
Last modified on
| 2026 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071873
