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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027221
Receipt No. R000022386
Scientific Title The effect of skin care products for topical acne treatments which frequently show adverse events.
Date of disclosure of the study information 2017/05/02
Last modified on 2017/05/02

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Basic information
Public title The effect of skin care products for topical acne treatments which frequently show adverse events.
Acronym The effect of skin care products for topical acne treatments
Scientific Title The effect of skin care products for topical acne treatments which frequently show adverse events.
Scientific Title:Acronym The effect of skin care products for topical acne treatments
Region
Japan

Condition
Condition acne vulgaris
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objectives of this experiment are assessments of safety, usefulness and effects for patients' quality-of-life of skin care for acne patients treated with adapalene or benzoyl peroxide which has frequently show adverse events on application sites.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes No deteriorating of the total number of eruptions in comparison of before and after the usage of the test formula.
Key secondary outcomes 1) The number of non-inflammatory acne eruptions at the beginning and end of the experiments.
2) The number of papule/inflammatory eruptions at the beginning and end of the experiments.
3) Global Severity at the beginning and end of the experiments.
4) Skin observation/Subjective symptom: 5 criteria on skin observation (dryness/ erythema/ scale) and subjective symptom (irritation/ pruritus) at the beginning and end of the experiments.
5) Change in medication during this trial.
6) Skin conductance for measuring water content in stratum corneum at the beginning and end of the experiments.(examined at Akihabara Skin Clinic)
7) General evaluation of the safety and usefulness by the dermatologists at the beginning and end of the test.
8) QOL Assessment according to Skindex-16 at the beginning and end of the experiments.
9) Questionnaire for patients at the beginning and end of the experiments.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Patients are instructed to apply the following skin care products and the topical medicine prescribed by dermatologists for 4 weeks. Patients apply Collage Cleansing Milk for removal of makeup, Collage Facial Soap for face wash in the morning, Collage face wash powder for face wash at night, and Collage moisturizing lotion and Collage moisturizing emulsion as moisturizer.
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
20 years-old <=
Age-upper limit
50 years-old >
Gender Male and Female
Key inclusion criteria Patients with acne vulgaris who has been treated with adapalene, benzyl peroxide and/or formulations including benzyl peroxide for more than 1 month.
Key exclusion criteria 1) Patients who are pregnant or under lactation.
2) Patients whose facial condition may affect the acne treatment.
3) Patients with medical history of cosmetic allergy.
4) Patients who received unusual skin care within 4 weeks prior to the study that might affect their skin condition.
5) Patients who have applied the cosmetics aimed for acne treatment within 4 weeks prior to the study.
6) Patients who has been defined by the doctor as inappropriate.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobukazu Hayashi
Organization Toranomon Hospital
Division name Department of Dermatology
Zip code
Address 2-2-2Toranomon, Minatoku, Tokyo, Japan
TEL 03-3588-1111
Email hayashi@toranomon.gr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobukazu Hayashi
Organization Toranomon Hospital
Division name Department of Dermatology
Zip code
Address 2-2-2Toranomon, Minatoku, Tokyo, Japan
TEL 03-3588-1111
Homepage URL
Email hayashi@toranomon.gr.jp

Sponsor
Institute Department of Dermatology, Toranomon hospital
Institute
Department

Funding Source
Organization Mochida Health Care Co.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Skin clinic Akihabara
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 虎の門病院(東京都),秋葉原スキンクリニック(東京)

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 02 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 Completed
Date of protocol fixation
2015 Year 12 Month 08 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 08 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 03 Month 31 Day
Date analysis concluded
2017 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 05 Month 02 Day
Last modified on
2017 Year 05 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022386

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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