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A prospective, single-arm study of the efficacy and safety of adalimumab in the treatment of facial granulomas

A prospective, single-arm study of the efficacy and safety of adalimumab in the treatment of facial granulomas

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300072368
Enrollment
Unknown
Registered
2023-06-12
Start date
2023-06-01
Completion date
Unknown
Last updated
2023-06-18

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

Conditions

granuloma faciale

Interventions

The adalimumab group:Not applicable

Sponsors

The First Affiliated Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) age greater than or equal to 18 years; 2) patients diagnosed with facial granuloma according to the accepted clinical and histopathological criteria; 3) If patients were receiving systemic therapy, this therapy had to be discontinued and, after a 4-week washout period, patients were kept off other medications during the study; 4) If the patient was receiving topical therapy, this therapy had to be discontinued, and after a 2-week washout period, the patient was kept off other medications during the study; 5) Women of childbearing potential must consent to use contraception during pregnancy 6) patients with written informed consent;

Exclusion criteria

Exclusion criteria: 1) pregnant and lactating women; 2) pregnant or lactating women of childbearing potential who are unable or unwilling to use contraception; 3) patients with acute or chronic infection, or with a history of active tuberculosis or hepatitis; 4) subjects with malignant tumors; 5) taking other immunosuppressive drugs at the same time, including but not limited to cyclosporine, tacrolimus and other drugs; 6) patients with severe heart, liver, kidney and other organ and systemic diseases; 7) Use of the trial drug was deemed inappropriate by other investigators

Design outcomes

Primary

MeasureTime frame
Proportion of patients achieving complete clinical remission (CR).;

Secondary

MeasureTime frame
Proportion of patients with a partial clinical response (PR);Changes of lesion surface characteristics by dermoscopy;

Countries

China

Contacts

Public ContactZheng Song

The First Affiliated Hospital of China Medical University

nyaadzs@163.com+86 133 2242 2777

Outcome results

None listed

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