Safe examination of the household hotpack

JRCT ID: jRCTs032180113

Registered date:08/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: fatigue
• Date of first enrollment: 25/02/2019
• Target sample size: 33
• Study type: Interventional
• Intervention(s): Put samples on skin of both calves.Once a day for 7days.6 to 8 hours.Make sure use at 16:00.

Outcome(s)

• Primary Outcome: Low-temperature burn
• Secondary Outcome: Skin symptoms,poor physical condition.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 49age old
• Gender: Both

Include criteria

1) Age20-49(At obtaining informed consent)Male and Female,Japanese.
2) Healthy subject.
3) Giving written informed consent.

Exclude criteria

1)History of serious liver disease,renal disorder,or heart disease.
2)Participating in other clinical study.
3)Possible pregnancy.
4)Cutaneous hypersensitivity.
5)Baseline desease or cutaneous symptom(atopic dermatitis,perioral dermatitis,rosacea etc) with general or local treatment
6)Diabetes,disease of hematogenous disorder,hyperhidrosis.
7)Cutaneous symptom(trauma,burn)on calves.
8)Skin allergy symptoms(rash,redness,itching,contact dermatitis etc) bycosmetics,fomentations,plasters.
9)Having a very good or bud warming.
10)Hives and eczema by touching to warm things for a long time.
11)Going to dermatology.
12)Hard walking employment(home delivery,construction worker) who can not use cooling sheet because coming off.
13)Judged as unsuitable for this study by the investigator or sub-investigator.

Related Information

• Primary Sponsor: Koikeda Takashi
• Secondary Sponsor: Ashitani Hiroaki,Lotte Co.,Ltd