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Safety evaluation study at the using time of household hotpack use

Safety evaluation study at the using time of household hotpack use - Safety evaluation study of household hotpack use

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000024083
Enrollment
30
Registered
2016-09-16
Start date
2016-09-20
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adult

Interventions

Put a sample over clothes (underwear, shorts etc) in the lower abdomen more than 8 hours

Sponsors

SOUKEN Co., Ltd
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: (1)Japanese (2)Female (3)Age:20~39 (At obtaining informed consent) (4)Subjects giving written informed consent

Exclusion criteria

Exclusion criteria: (1)Subjects who are judged as unsuitable for the study by the lead principal investigator. (2)Subjects who use topical cream to under abdomen. (3)Subjects who get hives and eczema by touching to warm things for a long time. (4)Subjects who have skin allergy and cutaneous hypersensitivity. (5)Subjects who are diabetes, disease of hematogenous disorder, hyperhidrosis, other disease of abdomen. (6)Subjects who have skin symptoms in under abdomen that affect the study. For example, scratch, pimple, verrcura, burn. (7)Subjects who have a navel piercing and tattoo in under abdomen. (8)Subjects who go to dermatology. (9)Subjects who are pregnant, could be pregnant in near future, or is breast feeding. (10)Subjects who participate in other clinical study. (11)Subjects who cause skin allergy symptoms (rash, redness, itching etc) by medicine, cosmetics, fomentations, plasters. (12)Subjects who have a very good or bud warming.

Design outcomes

Primary

MeasureTime frame
Presence or absence of low-temperature burn

Secondary

MeasureTime frame
Abnormality in the skin (discoloration, pain, itching, redness) Abnormality of physical condition

Countries

Japan

Contacts

Public ContactReiko Maruya

SOUKEN Co., Ltd Clinical trial management department

r_maruya@mail.souken-r.com03-5408-1555

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026