UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059941 |
|---|---|
| Receipt number | R000068074 |
| Scientific Title | A Clinical Use Study of Pure Golden Jojoba Oil in Patients with Atopic Dermatitis and Dry Skin |
| Date of disclosure of the study information | 2025/12/03 |
| Last modified on | 2025/12/02 11:56:36 |
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Basic information
Public title
A Clinical Use Study of Pure Golden Jojoba Oil in Patients with Atopic Dermatitis and Dry Skin
Acronym
Pure Golden Jojoba Oil Moisturizing Study for Atopic Skin
Scientific Title
A Clinical Use Study of Pure Golden Jojoba Oil in Patients with Atopic Dermatitis and Dry Skin
Scientific Title:Acronym
Jojoba Oil for Atopic Dermatitis - Moisturizing Study
Region
| Japan |
Condition
Condition
Atopic dermatitis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the moisturizing efficacy and safety of Pure Golden Jojoba Oil when applied to dry skin in patients with atopic dermatitis (AD).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of the Skin Dryness Score between the test-applied and non-applied sides at Week 4.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-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
| Other |
Interventions/Control_1
The test article (Pure Golden Jojoba Oil) shall be topically applied to the unilaterally assigned area on either the forearm or lower leg, twice per day (in the morning and evening), for a duration of four weeks. The corresponding contralateral area will serve as the untreated control.
Assessments will be conducted in a blinded manner by an evaluator who is unaware of the assignment codes (evaluator-blinded).
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients aged 18 years or older with atopic dermatitis.
2. Patients with AD who have maintained a remission state*1 for at least four weeks.
*1 Definition of remission:
The overall condition remains stable with an IGA score of 0 or 1.
The remission state can be maintained mainly with moisturizers, while anti-inflammatory topical agents*2 are used only on limited areas of the body. The use of oral JAK inhibitors or biologics is permitted.
*2 Anti-inflammatory topical agents- topical corticosteroids, tacrolimus ointment, delgocitinib ointment, difamilast ointment, and tapinarof cream.
3. Patients presenting with comparable skin dryness on both sides of the lower legs or forearms -evaluation sites.
Selection of Evaluation Sites
Both the left and right sides of either the lower legs or forearms will be designated as evaluation sites.
The application site and the non-application site of the test product will be randomly assigned to the left or right side.
If dryness is observed on both the lower legs and forearms, the lower legs will be selected as the evaluation sites.
Key exclusion criteria
Patients with inflammation at the evaluation site who are using anti-inflammatory topical medications
Patients with a history of contact dermatitis to cosmetics or similar products
Other patients deemed ineligible for the study by the principal investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuichiro |
| Middle name | |
| Last name | Tsunemi |
Organization
Department of Dermatology, Saitama Medical University
Nonprofit Organization Health Institute Research of Skin
Division name
Department of Dermatology
Zip code
101-0047
Address
Fukuda Building 2F, 1-8-9 Uchikanda, Chiyoda-ku, 101-0047,Tokyo, Japan
TEL
03-6435-3868
info@npo-hifu.net
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | Fukase |
Organization
EBC&M LLC
Division name
Scientific Planning Department
Zip code
1050011
Address
Shibamatsuobiru 4F, 2-9-1 Shibakoen, Minato-ku, Tokyo-to
TEL
0364353833
Homepage URL
jojoba_cr@ebc-m.com
Sponsor or person
Institute
Non-Profit Organization Health Institute Research of Skin
Institute
Department
Personal name
Funding Source
Organization
Dojin Iyaku-kako 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
Nonprofit Organization Skin Health Research Organization
Address
Fukuda Bldg. 2F, 1-8-9 Uchikanda, Chiyoda-ku, Tokyo-to
Tel
03-6435-3868
info@npo-hifu.net
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
| 2025 | Year | 12 | Month | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 10 | Month | 29 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 05 | 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
| 2025 | Year | 12 | Month | 02 | Day |
Last modified on
| 2025 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068074
