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Comparison of intervention of two molecules (crisaborole ointment and tacrolimus ointment) in the treatment of participants suffering from atopic dermatitis

Evaluation of Effectiveness, safety and change in biomarkers in Crisaborole versus Tacrolimus: search for a steroid free alternative in atopic dermatitis -double blind randomized clinical trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/096650
Enrollment
168
Registered
2025-10-30
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: L209- Atopic dermatitis, unspecified

Interventions

Intervention1: Crisaborole 2% ointment: To be applied twice daily over the affected areas, for 6 weeks Control Intervention1: Tacrolimus 0.1% ointment: To be applied twice daily over the affected area

Sponsors

Indian Association of Dermatologists, Venereologists and Leprologists
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with a clinical diagnosis of mild to moderate atopic dermatitis

Exclusion criteria

Exclusion criteria: Pregnant and lactating women, children less than 16 years of age, patients with severe atopic dermatitis, allergy to either study medications, , asthmatic patients requiring continuous inhaled corticosteroids

Design outcomes

Primary

MeasureTime frame
SCORAD, Investigator’s Static Global Assessment (ISGA), Eczema Area and Severity Index (EASI) scoreTimepoint: Day 0, 14, 28, 42

Secondary

MeasureTime frame
Quality of life by Patient-Oriented Eczema Measure (POEM)Timepoint: Day 0, 14, 28, 42

Countries

India

Contacts

Public ContactDr Anupam Das

KPC Medical College and Hospital

anupamdasdr@gmail.com9674852138

Outcome results

None listed

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