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Evaluate of clinical efficacy of autologous serum therapy

Evaluate of clinical efficacy of autologous serum therapy in patients with atopic dermatitis: a randomized, double-blind, placebo-controlled study

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CRIS
Registry ID
KCT0001969
Enrollment
50
Registered
2016-07-13
Start date
2015-12-02
Completion date
Unknown
Last updated
2023-03-06

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

Conditions

None listed

Interventions

Procedure/Surgery : Autologous serum aseptically seperated from the autologous blood or salinie will be administered to the patients by intramuscular injection, twice a week for 4 weeks (total 8 injec

Sponsors

Ajou University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adult patients with recalcitrant atopic dermatitis (age = 13 years) whose clinical conditions has not been effectively controlled by current standard medical therapies for more than 2 months 2. =10% lesion body surface area (BSA) of atopic dermatitis involvement in area at the screening and baseline visits

Exclusion criteria

Exclusion criteria: Exclusion criteria 1) Patients under the age of 13 year. 2) Patients who are unable to agree on their own (emergency patients, patients with mental disability, patients with limited capacity to consent due to stroke or delirium caused by diabetes). 3) Patients with severe disease whose expected survival duration is less than 3 months. 4) Pregnancy or planned pregnancy within 1 year 5) Skin condition not appropriate for blood sampling and transfusion 6) Presence of skin comorbidities that may interfere with study assessments

Design outcomes

Primary

MeasureTime frame
Proportion of patients with both a reduction of clinical severity scores by = 30% or =50% from baseline.

Secondary

MeasureTime frame
Safety verification;Blood test parameters (serum immunoglobulin, allergen-specific IgE, IgG autoantibodies, serum eosinophil cationic protein, cytokine, etc);Requirement for medication;Quality of life measured before and after the treatment

Countries

Korea, Republic of

Contacts

Public ContactMyoung-Eun Kim

Ajou University Hospital

pray1052@hanmail.net+82-31-219-7255

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 10, 2026