UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062385 |
|---|---|
| Receipt number | R000071399 |
| Scientific Title | A Multicenter Randomized Half-Face Controlled Study Evaluating the Efficacy and Safety of Short-Contact Therapy Using a High-Concentration Azelaic Acid Derivative Face Mask in Patients with Acne Vulgaris |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2026/07/29 14:37:59 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Study to Evaluate the Effects of a High-Concentration Azelaic Acid Derivative Face Mask on Acne Vulgaris
Acronym
AZMILE Study
Scientific Title
A Multicenter Randomized Half-Face Controlled Study Evaluating the Efficacy and Safety of Short-Contact Therapy Using a High-Concentration Azelaic Acid Derivative Face Mask in Patients with Acne Vulgaris
Scientific Title:Acronym
AZMILE Study
Region
| Japan |
Condition
Condition
Acne Vulgaris
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy, durability of response, and safety of short-contact therapy using a high-concentration azelaic acid derivative face mask in addition to standard therapy in patients with acne vulgaris.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of changes in inflammatory lesion counts, non-inflammatory lesion counts, and total lesion counts between the face mask-treated side and the untreated side at each assessment visit.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Short-contact therapy using a high-concentration azelaic acid derivative face mask (cosmetic) and Standard therapy for acne vulgaris
Interventions/Control_2
Standard therapy for acne vulgaris
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 16 years or older with acne vulgaris who have approximately symmetrical facial lesions, at least six inflammatory lesions and five non-inflammatory lesions on each side of the face, are receiving standard treatment under health insurance coverage, have no history of azelaic acid treatment, and have no known allergy to azelaic acid.
Key exclusion criteria
Patients with facial eczema, dermatitis, or other significant skin disorders; patients who have participated in another clinical study within the previous 3 months; patients with severe cardiac, renal, hepatic, respiratory, or cardiovascular disorders; and patients considered unsuitable for participation by the principal investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Kawashima |
Organization
Nishi-Shinjuku Skin Care Clinic
Division name
Director
Zip code
1600023
Address
Suite 401, 4th Floor, Sankyo Nishi-Shinjuku Building, 4-2-18 Nishi-Shinjuku, Shinjuku-ku, Tokyo
TEL
0359906078
contact@b-hr.jp
Public contact
Name of contact person
| 1st name | Naomi |
| Middle name | |
| Last name | Shima |
Organization
Beauty and Health Research Co., Ltd.
Division name
Clinical Research Department
Zip code
1600023
Address
Suite 401, 4th Floor, Sankyo Nishi-Shinjuku Building, 4-2-18 Nishi-Shinjuku, Shinjuku-ku, Tokyo
TEL
0353547388
Homepage URL
shima@b-hr.jp
Sponsor or person
Institute
Nishi-Shinjuku Skin Care Clinic
Institute
Department
Personal name
Makoto Kawashima
Funding Source
Organization
Lohas Medical Co., Ltd.
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
Noguchi Dermatology Clinic Institutional Review Board
Address
964-1 Kamishima, Kashima-machi, Kamimashiki-gun, Kumamoto 861-3101, Japan
Tel
0962374112
info@nogcli.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
| 2026 | Year | 08 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2027 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 29 | Day |
Last modified on
| 2026 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071399
