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Efficacy and safety of minocycline combined with low-dose glucocorticoid versus medium-dose glucocorticoid as initial treatment for bullous pemphigoid:a perspective multicenter randomized double blind and parallel control study

Efficacy and safety of minocycline combined with low-dose glucocorticoid versus medium-dose glucocorticoid as initial treatment for bullous pemphigoid:a perspective multicenter randomized double blind and parallel control study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060454
Enrollment
Unknown
Registered
2022-06-01
Start date
2022-05-22
Completion date
Unknown
Last updated
2024-05-21

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

Conditions

Bullous pemphigoid (BP)

Interventions

experimental group:minocycline combined with low-dose glucocorticoids group
control group:medium-dose glucocorticoids

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. BP was confirmed (positive for clinical manifestations, histology, direct immunofluorescence and anti-BP180 antibody); 2. Moderate to severe (10-50%BSA); 3. Aged 50-80 years, no gender limit; 4. Had not received immunosuppressive therapy, systemic glucocorticoid therapy or biologics in the last 3 months before screening; 5. Volunteer as a subject and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. BP patients with mainly mucosal manifestations/only mucosal involvement; 2. Combined with other skin diseases, such as psoriasis, urticaria, eczema, which can affect the judgment of curative effect; 3. Pregnant/lactating patients/patients planning to become pregnant in the near future; 4. Participate in another clinical study within the last 3 months; 5. Patients who cannot be followed up regularly; 6. Karnofsky <50 points; 7. Use drugs that interact with the drugs in the study due to other diseases; 8. Absolute contraindications for minocycline/glucocorticoid use (e.g., allergy to study drug, use of attenuated live vaccine within 1 month, combination of severe infection, severe uncontrolled hyperglycemia/hypertension, severe heart, lung, liver and renal insufficiency, etc.); 9. Tumors with malignant neoplasms (excluding non-melanoma skin cancer/carcinoma excised in situ); 10. Severe, uncontrolled mental illness/neurological disease; 11. Patients addicted to alcohol or drugs; 12. The presence of other critical illnesses or other conditions that the clinician has determined preclude participation in the study.

Design outcomes

Primary

MeasureTime frame
treatment effect;adverse reaction;

Secondary

MeasureTime frame
cumulative dose of glucocorticoids used;treatment costs;

Countries

China

Contacts

Public ContactWang Mingyue
wangmy@pku.edu.cn+86 10 83573075

Outcome results

None listed

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