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Clinical study on irritation and sensitization of earphone materials

Clinical study on irritation and sensitization of earphone materials

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066325
Enrollment
Unknown
Registered
2022-12-01
Start date
2022-12-05
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Ear skin disease

Interventions

Part ?:Pach test

Sponsors

Beijing ChuiYangLiu Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Part I (Clinical case study) : (1) X earphones has been used for more than 1 month and is continuing to be used; (2) The following clinical manifestations occurred after X earphone was used; Skin rashes of external ear and auricle, mainly erythema, papule, herpetic rashes, itching or tingling sensation of different degrees; (3) ears are not exposed to other materials that can cause allergic dermatitis; (4) agree to conduct patch test, bacterial culture, skin test and other methods to find the cause of disease. (5) Consent to personal information collection, such as demographic, living habits, usage habits, symptoms, photo collection, etc. Part II (Patch test): (1) Healthy people without allergic skin diseases; (2) No history of allergic diseases, such as eczema, contact dermatitis, allergic rhinitis, asthma, etc.

Exclusion criteria

Exclusion criteria: Part I (Clinical case study) : ? People who have not used X earphone for a long time; ? Do not agree to personal information collection. ? Patients without clinical symptoms. The second part (patch test) : Patch test is not suitable for the following situations: ? patients with a history of rapid contact reaction (such as contact urticaria); ? Patients with a history of systemic allergic reactions related to contact allergens; ? Pregnant and lactating women; (4) Patients who have no behavioral control ability or cannot guarantee the conditions of patch test; (5) For those who are using glucocorticoids, if the dosage of prednisone is less than or equal to 0.4 mg/kg per day, the effect is usually small; otherwise, it should wait until 2 weeks after drug withdrawal; For topical use of glucocorticoids at the patch test site, wait until 1 week after discontinuation.

Design outcomes

Primary

MeasureTime frame
Pach test;

Countries

China

Contacts

Public ContactShaowei Cheng

Beijing Chuiyangliu Hospital

13911996360@139.com13911996360

Outcome results

None listed

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