UMIN-CTR Clinical Trial

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
Email	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
Email	ytateoka@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056494