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A Single-center clinical study to evaluate the safety and efficacy of recombinant type XVII collagen in the repair of cutaneous bullous diseases

A Single-center clinical study to evaluate the safety and efficacy of recombinant type XVII collagen in the repair of cutaneous bullous diseases

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070035
Enrollment
Unknown
Registered
2023-03-31
Start date
2023-04-01
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

cutaneous bullous diseases

Interventions

Test group:Recombinant XVII collagen gel dressing

Sponsors

Department of Dermatology, the First People 's Hospital of Changzhou
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18 to 90 years, male or female; (2) The wound diagnosis meets the following items: A) Clinical diagnosis of bullous pemphigoid (BP); B) As confirmed by the clinician, dressing change is still required for 3 weeks or more; C) Target wound surface = 10 cm2; (3) Agree to participate in this study and sign a written informed consent.

Exclusion criteria

Exclusion criteria: (1) Severe malnutrition, albumin 38.5? or white blood cells > 12 × 109/L or wound edge redness > 5 cm; (3) Uncontrollable multi-drug resistant bacterial infection or severe systemic infection; (4) Known to have a history of allergy or allergic constitution (allergic to two or more allergens) similar to the components or other chemical structures contained in this product and the control product; (5) Pregnant or lactating women and those who have fertility plans in the past 6 months; (6) Participated in other clinical investigators within 1 month before inclusion; (7) Other researchers think it is not appropriate to participate in clinical research;

Design outcomes

Primary

MeasureTime frame
Clinical efficiency;Wound Area Measurements;

Secondary

MeasureTime frame
Adverse events;Vital signs;Liver and renal function;

Countries

China

Contacts

Public ContactZhang Ruzhi

The First People 's Hospital of Changzhou

zhangruzhi628@163.com18761161826

Outcome results

None listed

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