UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of skin care products for topical acne treatments which frequently show adverse events.
Title of the study (Brief title)	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	Nobukazu Hayashi
Organization	Toranomon Hospital
Division name	Department of Dermatology
Address	2-2-2Toranomon, Minatoku, Tokyo, Japan
TEL	03-3588-1111
Email	hayashi@toranomon.gr.jp

Public contact
Name of contact person	Nobukazu Hayashi
Organization	Toranomon Hospital
Division name	Department of Dermatology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 08 Day
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

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Publication of results	Unpublished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