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A clinical control study on the safety and efficacy of Aleeto transdermal microneedle in the treatment of idiopathic facial paralysis in the recovery period

A clinical control study on the safety and efficacy of Aleeto transdermal microneedle in the treatment of idiopathic facial paralysis in the recovery period

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099150
Enrollment
Unknown
Registered
2025-03-19
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

Idiopathic facial paralysis

Interventions

Test group:From the first day of the experiment, the local subcutaneous administration of Aleeto scalp microneedles (100 µ g of Aleeto per patch) was given to the affected side of Yangbai acupoint, Ji
Control group:From the first day of the experiment, blank microneedles were given every 3 days at the affected side of Yangbai, Jiache, Dicang, Yingxiang, bilateral Taiyang, Hegu, and Sibai for a tota

Sponsors

Yuquan Hospital of Tsinghua University (Tsinghua University Hospital of integrated traditional Chinese and Western Medicine)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Meet the ifnp diagnostic criteria; 2. Age 18-65 years old, both male and female; 3. Ifnp recovery period, duration of 3-6 months; 4. H-B grade is II-V; 5. Patients with only one side facial paralysis; 6. Voluntarily participate in this clinical trial, give informed consent and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with central facial paralysis; 2. Patients with secondary facial paralysis caused by encephalitis, trauma, tumor or other reasons; 3. Patients with major diseases such as cardiovascular, cerebrovascular, liver and kidney dysfunction, endocrine system diseases, hematopoietic system and other diseases or systemic organ failure, as well as psychiatric patients; 4. Patients with poor compliance and unable to cooperate with follow-up; 5. Patients or family members refused to cooperate with the experimenter.

Design outcomes

Primary

MeasureTime frame
House-Brackmann sacle;Sunnybrook sacle;Portmann scale;Self rating Anxiety Scale;Self rating Depression Scale;Blink reflex examination;EMG of facial nerve;

Countries

China

Contacts

Public ContactXin Pan

Yuquan Hospital of Tsinghua University (Tsinghua University Hospital of integrated traditional Chinese and Western Medicine)

luciflous@126.com+86 88257755

Outcome results

None listed

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