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A study of adhesion to skin for film dressings

A randomized, comparative study of adhesion to skin between two firm dressings in healthy participants - A randomized, comparative study of adhesion to skin between two firm dressings in healthy participants

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000055805
Enrollment
26
Registered
2024-10-11
Start date
2023-10-18
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 participants

Interventions

Right forearm: Dressing A Left forearm: Dressing B Right forearm: Dressing B Left forearm: Dressing A

Sponsors

SOUKEN Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Japanese female and male participants who were aged 20 to 49 years 2. Healthy aprticipants who has no history of outpatient visits or medication for disease treatment 3. Participants who have healthy skin 4. Participats who are able to provide informed consent 5. Participats who are able to shave forearm hair with a T-shaped razor, if necessary.

Exclusion criteria

Exclusion criteria: 1. Participants who have a history of previous treatment applied to the skin, particularly within the previous 2 weeks 2. Participants who have a history of anaphylactoid symptoms 3. Participants who have a history of hypersensitivity symptoms when applying a skin dressing or bandage 4. Participants who have a current history of atopic dermatitis 5. Participants who have a skin symptoms such as wounds or eczema on the forearm 6. Participants who have excessive hairiness on the forearm.

Design outcomes

Primary

MeasureTime frame
Adhesion to the skin after 4 days of dermal application

Secondary

MeasureTime frame
Adhesion, itchiness, pain, skin maceration, adhesive residue, skin reaction

Countries

Japan

Contacts

Public ContactShiori Sakurai

NICHIBAN CO., LTD. Medical Regulatory Affairs

shio-murayama@nichiban.co.jp03-5978-5089

Outcome results

None listed

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