Spanish Academy of Dermatology and Venereology Registry of Atopic Dermatitis Therapy

Condition(s) studied

Investigational drug(s) / intervention(s)

Ciclosporin: Any systemic drug used for atopic dermatitis in clinical practice

Study summary

The Spanish Registry of Systemic therapy in atopic eczema, BIOBADATOP, assesses drug safety and treatment effectiveness as well as treatment impact on quality of life in children and adults with atopic eczema receiving systemic immuno-modulatory therapies in Spanish daily practice.

The main objectives are:

1. To assess short and long-term safety of systemic therapies (including phototherapy) for atopic eczema (pharmacovigilance).
2. To assess short and long-term effectiveness of systemic therapies, providing a basis for shared decision making and guidelines.

Secondary objectives are:

1. To assess short and long-term safety of topical therapies for atopic eczema.
2. To assess effectiveness of different methods of care, including patient training.
3. To describe atopic dermatitis comorbidities.

Eligibility

Primary outcome measure(s)

• Rates of adverse events — through study completion, an average of 3 years
  For each drug or drug type
• Relative rate of adverse events — through study completion, an average of 3 years
  Compared to a standard drug ( such as cyclosporine). Crude and adjusted

Trial sites (9)

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