臨床研究等提出・公開システム

Safe evaluation examination of the household hotpack (Safe evaluation examination of the household hotpack)

Safe examination of the household hotpack (Safe examination of the household hotpack)

32

1)Age 20-49(At obtaining informed consent)Male and Female,Japanese. 2)Healthy subject. 3)Giving written informed consent.

Healthy males and females with the age between 20 and 49 were recruited. Informed consent was obtained and 32 males and females were registered on February 25th. Medical diagnoses were performed for primary outcomes (low-temperature burn) and secondary outcomes (skin symptoms, poor physical condition) by dermatologists on the same day. Subjects used the test samples following the directions for use for 7 days from February 26th to march 4th. Medical diagnoses were performed for primary outcomes and secondary outcomes by dermatologists on March 5th followed with comprehensive judgments of safety.

(before use) Primary outcomes (low-temperature burn) : No symptoms. Secondary outcomes (skin symptoms, poor physical condition): No symptoms. (after use) Primary outcomes (low-temperature burn) : No symptoms. Secondary outcomes (skin symptoms, poor physical condition): 4 of 32 subjects had skin symptoms. The other 28 subjects had no symptoms.

Primary outcomes (low-temperature burn), Secondary outcomes (poor physical condition):No symptoms. Secondary outcomes (skin symptoms) were occurred as below. Subject 1: Back side of both lower legs were dotted with erythema. No itching. Subject 2: Erythema appeared from 3 days after the start of use. Mild itching. Subject 3: Erythema were seen on adhesive tape area. No itching. Subject 4: Erythema were seen on adhesive area. Mild itching.

This study showed mild skin symptoms for 4 subjects and no symptoms for 28 subjects of all the 32 subjects based on medical findings after the use. Subject 1 is supposed to have had dermatitis due to sealed condition. Sebject2 is supposed to have had mild irritant dermatitis due to the test samples. Subject 3 and 4 are supposed to have had symptoms due to materials of adhesive, strength of adhesive force and contact dermatitis when removing adhesive.

Dec. 09, 2019

No

No

https://jrct.mhlw.go.jp/latest-detail/jRCTs032180113

Koikeda Takashi

Shiba Palace Clinic

6F Daiwa A Hamamatucho Bld.,1-9-10 Hamamatsucho,Minato-ku,Tokyo

shiba_palace@s-palace-clinic.com

Motooka Rika

SOUKEN Co.,Ltd

3F Daiwa A Hamamatucho Bld.,1-9-10 Hamamatsucho,Minato-ku,Tokyo

+81-3-5408-1555

r_motooka@mail.souken-r.com

Complete

Jan. 11, 2018

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

single assignment

health services research

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

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.

Both

fatigue

Put samples on skin of both calves.Once a day for 7days.6 to 8 hours.Make sure use at 16:00.

Low-temperature burn

Skin symptoms,poor physical condition.

+81-43-206-4706

Dec. 28, 2018

none