UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027221 |
|---|---|
| Receipt number | 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 13:20:41 |
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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
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
hayashi@toranomon.gr.jp
Sponsor or person
Institute
Department of Dermatology, Toranomon hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022386
