Tokyo, Oct. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059535) titled 'Effects of topical agents for reducing finger fatigue in hairdressers and beauticians' on Oct. 24.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Saitama Prefectural University
Condition:
Condition - Prevention of muscle fatigue in healthy individuals
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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
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 Size - 45
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068099
Disclaimer: Curated by HT Syndication.