UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059535 |
|---|---|
| Receipt number | R000068099 |
| Scientific Title | Verification of the efficacy of topical agents and blood circulation promoters for reducing work load in hairdressers and beauticians |
| Date of disclosure of the study information | 2025/10/24 |
| Last modified on | 2025/10/24 16:06:52 |
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Basic information
Public title
Effects of topical agents for reducing finger fatigue in hairdressers and beauticians
Acronym
Hairdresser Fatigue Reduction Study
Scientific Title
Verification of the efficacy of topical agents and blood circulation promoters for reducing work load in hairdressers and beauticians
Scientific Title:Acronym
Verification of the efficacy of topical agents and blood circulation promoters for reducing work load in hairdressers and beauticians
Region
| Japan |
Condition
Condition
Prevention of muscle fatigue in healthy individuals
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the efficacy of combined intervention using topical anti-inflammatory analgesics and functional cosmetics with blood flow-promoting effects for occupational disease prevention in hairdressers and beauticians. To clarify the effect of topical agents in suppressing muscle fatigue by counteracting the shift to lower frequencies in electromyographic signals and local blood flow reduction that occur with continuous scissors opening/closing motions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle fatigue (changes in median frequency of surface electromyography) and subjective fatigue and pain (Visual Analogue Scale: VAS)
Key secondary outcomes
Skin surface blood flow, electromyographic discharge (%MVE), subjective evaluation scores at each measurement time point
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine | Other |
Interventions/Control_1
In the topical anti-inflammatory analgesic group: Apply 1 g of the topical anti-inflammatory analgesic to the forearm (radial wrist extensor area) and 0.2 g to the thenar area. Allow 10 minutes for absorption, then perform a 3-minute scissor-opening and closing task
Interventions/Control_2
In the functional cosmetics group: Apply 1 g of the functional cosmetics to the forearm (radial wrist extensor area) and 0.2 g to the thenar area. Allow 10 minutes for absorption, then perform a 3-minute scissor-opening and closing task
Interventions/Control_3
In the placebo group: Apply 1 g of Vaseline to the forearm (radial wrist extensor area) and 0.2 g to the thenar area. Allow 10 minutes for absorption, then perform a 3-minute scissor-opening and closing task
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Female undergraduate students aged 18 years or older, who are right-handed and enrolled at Saitama Prefectural University
2. No history of orthopedic diseases in the upper extremities
3. No known allergy to any component of the topical agents used in this study
4. No sensory or motor disorder in the upper extremities
5. Received sufficient explanation of the purpose and content of this study and provided written informed consent
6. No physical functional problems in daily life, and judged to be able to participate safely in the study
7. Able to expose the skin from fingertips to upper arms for topical agent application
8. No known allergy to any component of the topical agents used in this study
Key exclusion criteria
1. Those with metal allergy
2. Those with inflammation, trauma, or skin diseases (atopic dermatitis, eczema, etc.) at the application site
3. Those with heart disease, neurological disease, or other serious underlying conditions
4. Those with a history of hypersensitivity reactions to topical agents (aspirin preparations: ASA), adverse effects common to NSAIDs (non-steroidal anti-inflammatory drugs), or aspirin-induced asthma
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Koizumi |
Organization
Saitama Prefectural University
Division name
Department of Occupational Therapy/Graduate School of Health and Social Services
Zip code
3438540
Address
820 Sannomiya, Koshigaya-shi, Saitama, Japan
TEL
0489734125
koizumi-kohei@spu.ac.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Koizumi |
Organization
Saitama Prefectural University
Division name
Department of Occupational Therapy/Graduate School of Health and Social Services
Zip code
3438540
Address
820 Sannomiya, Koshigaya-shi, Saitama, Japan
TEL
0489734125
Homepage URL
koizumi-kohei@spu.ac.jp
Sponsor or person
Institute
Saitama Prefectural University
Institute
Department
Personal name
Funding Source
Organization
Rohto Pharmaceutical 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
Saitama Prefectural University Research Ethics Review Committee
Address
820 Sannomiya, Koshigaya, Saitama, Japan
Tel
048-973-4125
koizumi-kohei@spu.ac.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
| 2025 | Year | 10 | Month | 24 | 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
| 2025 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 24 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2025 | Year | 10 | Month | 24 | Day |
Last modified on
| 2025 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068099
