UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of usefulness and safety of heparinoid agent based external medicine (over counter drug) for facial dryness symptom.
Title of the study (Brief title)	Usefulness of heparinoid agent based external medicine for facial dryness symptom.
Region	Japan

Condition
Condition	facial dryness symptom
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Examination of usefulness and safety of heparinoid agent based external medicine (over counter drug) for facial dryness symptom.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	At the time of strating, 2 weeks later and 4 weeks later. The measurement of a. Wrinkle and pigmented spot. b. Moisture content of the stratum corneum. c. Transepidermal water loss. d. Skin elasticity. e. Tape stripping of corneocyte.
Key secondary outcomes	Change of the subjective symptoms of the subject.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Test medicine is used for right face, and placebo medicine is used for left face, for 4 weeks twice a day.
Interventions/Control_2	Placebo medicine is used for right face, and test medicine is used for left face, for 4 weeks twice a day.
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	35 years-old <=
Age-upper limit	65 years-old >=
Gender	Female
Key inclusion criteria	The person who fells facail dryness symptom.
Key exclusion criteria	The person 1. Who takes in an oral pharmaceutical product or a supplement which may affect the skin condition habitually. 2. Who had the anamnestic history of surgical operation on the testing area. 3. Who is infected with hemorrhagic disease. 4. Who has skin rash of atopic dermatitis on face. 5. Who uses regularly an external medicine. 6. Who had the anamnesis of heparinoid allergy. 7. Who has allergy or sensitivity to drug and cosmetics. 8. Who can not agree that using same cosmetics all over the study time. 9. Who has skin disease on the testing area. 10. Who has the factor on the testing area which may affect the result. 11. Who has critical illness of glucose metabolism, lipid metabolism, liver function, renal function, cardiovascular system, respiratory tract, endocrine system, immune system and nervous system, or had the anamnestic history of psychiatric disorder. 12. Who can not understand about examination contents. 13. Who is pregnant or lactating. 14. Who is impossible to come to the testing institution on an examination day. 15. Who participates in other examinations. 16. Who is recognized to be inappropriate as a subject by attending physician.
Target sample size	50

Research contact person
Name of lead principal investigator	Daisuke Tsuruta
Organization	Osaka city university graduate school of medicine
Division name	department of dermatology
Address	1-4-3 Asahimachi Abeno-ku Osaka
TEL	06-6645-3826
Email	dtsuruta@med.osaka-cu.ac.jp

Public contact
Name of contact person	Daisuke Tsuruta
Organization	Osaka city university graduate school of medicine
Division name	department of dermatology
Address	1-4-3 Asahimachi Abeno-ku Osaka
TEL	06-6645-3826
Homepage URL
Email	dtsuruta@med.osaka-cu.ac.jp

Sponsor
Institute	Osaka city university graduate school of medicine, department of dermatology
Institute
Department

Funding Source
Organization	Kobayashi pharmaceutical Co., Ltd
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Nikoderm research Inc., CIEL Co., Ltd.
Name of secondary funｄer(s)

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	株式会社ニコダームリサーチ(大阪府）Nikoderm research Inc. (Osaka-fu)

Other administrative information
Date of disclosure of the study information	2015 Year 09 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 02 Day
Anticipated trial start date	2015 Year 11 Month 12 Day
Last follow-up date	2015 Year 12 Month 24 Day
Date of closure to data entry	2016 Year 05 Month 31 Day
Date trial data considered complete	2016 Year 11 Month 30 Day
Date analysis concluded	2016 Year 11 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 09 Month 11 Day
Last modified on	2018 Year 10 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021959