UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049604 |
|---|---|
| Receipt number | R000056494 |
| Scientific Title | Intervention study on the effectiveness of a new nipple care cream focusing on aloe ingredients. |
| Date of disclosure of the study information | 2022/11/25 |
| Last modified on | 2022/11/25 00:28:32 |
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Basic information
Public title
Research on the effectiveness of a new nipple care cream focusing on aloe ingredients.
Acronym
Research on the effectiveness of a new nipple care cream focusing on aloe ingredients.
Scientific Title
Intervention study on the effectiveness of a new nipple care cream focusing on aloe ingredients.
Scientific Title:Acronym
Intervention study on the effectiveness of a new nipple care cream focusing on aloe ingredients.
Region
| Japan |
Condition
Condition
Not applicable (normal papilla)
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the characteristics of a nipple care cream in terms of water retention and extensibility on nipple skin with those of lanolin-based care products.
Basic objectives2
Others
Basic objectives -Others
Characteristics for water retention and extensibility on nipple skin.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Nipple moisture content (%) as primary outcomes.
Key secondary outcomes
Nipple extensibility (mm), nipple skin hardness (Bishop score), skin sensation during lactation and impressions of nipple cream use as key secondary outcomes.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
No application to the nipple.
Interventions/Control_2
Applying nipple care cream to the nipple (18 weeks).
Interventions/Control_3
Applying REPAIR NIPPLE to the nipple (18 weeks).
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
| 45 | years-old | > |
Gender
Female
Key inclusion criteria
The patient must be pregnant, have normal nipples, and provide written consent from the patient.
Key exclusion criteria
Women with nipple shape that is not normal (folded or inverted nipples), women with skin inflammation or disease such as atopic dermatitis,Women with sensitivity or allergy to lanolin or aloe ingredients, women who are already taking routine nipple care (moisturizers, creams, etc.) at 24 weeks of pregnancy, and women who do not wish breastfeeding.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yumiko |
| Middle name | |
| Last name | Tateoka |
Organization
Shiga University of Medical Science
Division name
Department of Clinical Nursing, Division of Maternity Nursing
Zip code
520-2192
Address
Tsukinowa-cho, Seta, Otsu-shi, Shiga, Japan
TEL
077-548-2433
ytateoka@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Yumiko |
| Middle name | |
| Last name | Tateoka |
Organization
Shiga University of Medical Science
Division name
Department of Clinical Nursing, Division of Maternity Nursing
Zip code
520-2192
Address
Tsukinowa-cho, Seta, Otsu-shi, Shiga, Japan
TEL
077-548-2433
Homepage URL
ytateoka@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Pigeon Home Products Corporation
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
Shiga University of Medical Science Research Ethics Committee.
Address
Tsukinowa-cho, Seta, Otsu-shi, Shiga, Japan
Tel
077-548-3576
hqrec@belle.shiga-med.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
| 2022 | Year | 11 | Month | 25 | 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
| 2022 | Year | 08 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 25 | Day |
Last modified on
| 2022 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056494
