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Skin Primary Irritation Test in Humans

Skin Primary Irritation Test in Humans

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CRIS
Registry ID
KCT0004022
Enrollment
30
Registered
2019-05-31
Start date
2019-05-13
Completion date
Unknown
Last updated
2019-06-17

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

Conditions

None listed

Interventions

Others(cosmetics) : Upper back of 30 healthy women subjects attach the closed patch test of test product (2 products) for 48 hours. Reactions were assessed at 30 mins, 24 hrs after patch removal by t

Sponsors

Dermapro
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: ? Healthy females or males aged 20 to 60 years ? Subjects who signed the informed consent; the purpose and the protocol of the study are explained to subjects. ? Subjects who are willing to cooperate with the requirements of the study during the test period and contact investigator immediately if they experience any adverse reaction. ? Subjects should be cooperative and available for follow-up during the study period.

Exclusion criteria

Exclusion criteria: ? Women who are self-reported pregnant, nursing or planning a pregnancy ? Subjects with a history of any dermatological disease or condition, including but not limited to active atopic dermatitis, psoriasis, eczema, active seasonal allergies within the past a months ? Subjects with abnormal skin pigmentation at the test sites which might interfere with subsequent evaluations of dermal responsiveness ? Subjects taking medications which might interfere with the test results, including anti-inflammatory, antihistamines or immunosuppressive drugs ? Subjects who have applied any type of topical anti-inflammatory medication to the test sites within two weeks prior to enrollment ? Subjects with any other skin condition that would interfere with the conduct of the study ? Subjects with a history of immune deficiency or auto-immune disease ? Subjects who are currently receiving allergy injections, have received allergy injections within one week prior to enrollment, or expect to begin receiving allergy injections during the study ? Subjects who are currently under treatment for chronic diseases (asthma and diabetes etc.) ? Current enrollment in any other research study or participation in a patch test study within 30 days prior to the start of this study ? Subjects who are known tape/adhesive reactors

Design outcomes

Primary

MeasureTime frame
skin irritation

Secondary

MeasureTime frame
skin irritation index

Countries

Korea, Republic of

Contacts

Public ContactJahyun Ryu

Dermapro

dermatpi@dermapro.co.kr+82-2-597-5435

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026