NCT05674695

Spanish Academy of Dermatology and Venereology Registry of Atopic Dermatitis Therapy

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,500 (estimated)
• Sponsor: Fundación Academia Española de Dermatología · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Dermatitis, Atopic

Interventions

Type	Name	Description
DRUG	Ciclosporin	Any systemic drug used for atopic dermatitis in clinical practice

Timeline

• Start date: 2019-01-01
• Primary completion: 2029-01-01
• Completion: 2029-01-01
• First posted: 2023-01-06
• Last updated: 2023-01-06

Locations

9 sites across 1 country: Spain

Regulatory

• FDA-regulated drug study