UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062384 |
|---|---|
| Receipt number | R000071394 |
| Scientific Title | A Multicenter Randomized Half-Face Controlled Study Evaluating the Efficacy and Safety of AviClear in Combination with Standard Therapy in Patients with Acne Vulgaris |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2026/07/29 14:14:07 |
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Basic information
Public title
A Study to Evaluate the Effects of AviClear Laser Therapy Combined with Standard Treatment for Acne
Acronym
A Study of AviClear Laser Therapy for Acne
Scientific Title
A Multicenter Randomized Half-Face Controlled Study Evaluating the Efficacy and Safety of AviClear in Combination with Standard Therapy in Patients with Acne Vulgaris
Scientific Title:Acronym
ACCLAIM Study
Region
| Japan |
Condition
Condition
Acne Vulgaris
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the efficacy and safety of AviClear in combination with standard therapy in patients with acne vulgaris and to determine whether the combination treatment provides greater improvement in acne lesions and facilitates remission compared with standard therapy alone.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of inflammatory lesion counts, comedone counts, and total lesion counts between the AviClear-treated side and the control side.
Key secondary outcomes
Plain Text1Remission and near-remission rates, comparative treatment efficacy between facial sides, changes in sebum production, incidence of adverse events, and photographic assessment of the treated and control sides.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Standard therapy for acne vulgaris plus AviClear laser treatment administered to one randomly assigned side of the face at baseline, Week 4, and Week 8.
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 fewer than three cysts or nodules, are receiving standard acne treatment according to clinical guidelines or are untreated at enrollment, and have at least six inflammatory lesions and five non-inflammatory lesions (comedones) on each side of the face with comparable bilateral severity.
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
30
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
None
Organization
Division
Category of Funding Organization
Self funding
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 | 06 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2027 | Year | 05 | Month | 31 | 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=R000071394
