Comparison of locally applied tacrolimus, crisaborole and mometasone in patients aged more than 2 years with mild to moderate atopic dermatitis.

Efficacy, safety and economic analysis of topical preparations in patients with mild to moderate atopic dermatitis AD: a randomized open-labelled active controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/066965

Enrollment

Registered

2024-05-07

Start date

Unknown

Completion date

Unknown

Last updated

2024-05-27

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: Topical 2% Crisaborole applied twice a day for 4 weeks Control Intervention1: Tacrolimus: Topical age-appropriate dose of Tacrolimus applied twice a day for 4 weeks Control

Eligibility

Inclusion criteria

Inclusion criteria: 1.Non-immunocompromised males or females aged 2 years or older with a clinical diagnosis of mild to moderate Atopic Dermatitis 2.An IGA of disease severity of at least mild to moderate at baseline (a score of 2 or 3)

Exclusion criteria

Exclusion criteria: 1.Pigmented lesion(s) in any treatment area at baseline, which would interfere with evaluations 2.History of any confounding skin conditions 3.History or presence of HIV, diabetes, malignancy, serious active or recurrent infection, clinically significant severe renal insufficiency or severe hepatic disorders 4.Use within 14 days of baseline of: 1) systemic antibiotics, 2) calcipotriene or other vitamin D preparations, or 3) retinoids or 4) study drugs 5.Known allergy or hypersensitivity to study drugs

Design outcomes

Primary

Measure	Time frame
To assess the Proportion of patients with treatment success (a score of 0 or 1 within the treatment area) based on the Investigator’s Global Assessment of Disease Severity (IGA) with topical preparations (Crisaborole Vs Tacrolimus Vs Steroid) in patients with mild to moderate Atopic DermatitisTimepoint: 2 weeks and 4 weeks	—

Secondary

Measure	Time frame
To assess the number of patients needed the rescue medicine therapy after 2 weeks of treatmentTimepoint: 2 weeks and 4 weeks;To evaluate the Adverse events in each arm, coded as per MedDRA, with topical preparations (Crisaborole Vs Tacrolimus Vs Steroid) in patients with mild to moderate Atopic DermatitisTimepoint: 2 weeks and 4 weeks;To evaluate the Change from baseline to 4 weeks in EASI (Eczema area and severity index) with topical preparations (Crisaborole Vs Tacrolimus Vs Steroid) in patients with mild to moderate Atopic DermatitisTimepoint: 2 weeks and 4 weeks;To evaluate the Change from baseline to 4 weeks in IGA (investigators global assessment) score with topical preparations (Crisaborole Vs Tacrolimus Vs Steroid) in patients with mild to moderate Atopic DermatitisTimepoint: 2 weeks and 4 weeks;To evaluate the Change from baseline to 4 weeks in PP-NRS (Peak Pruritus Numerical Rating Scale) with topical preparations (Crisaborole Vs Tacrolimus Vs Steroid) in patients with mild to moderate Atopic DermatitisTimepoint: 2 weeks and 4 weeks;To evaluate the Change from baseline to 4 weeks in QoL (Quality of life) with topical preparations (Crisaborole Vs Tacrolimus Vs Steroid) in patients with mild to moderate Atopic DermatitisTimepoint: 2 weeks and 4 weeks;To evaluate the Change from baseline to 4 weeks in SCORAD (Scoring Atopic Dermatitis) with topical preparations (Crisaborole Vs Tacrolimus Vs Steroid) in patients with mild to moderate Atopic DermatitisTimepoint: 2 weeks and 4 weeks;To evaluate the cost-effectiveness for the proportion of patients with treatment success (a score of 0 or 1 within the treatment area) based on the Investigator’s Global Assessment of Disease Severity (IGA) with topical preparations (Crisaborole Vs Tacrolimus Vs Steroid) in patients with mild to moderate Atopic DermatitisTimepoint: 2 weeks and 4 weeks;To evaluate the cost-utility based on quality of life with topical preparations (Crisaborole Vs Tacrolimus Vs Steroid) in patients wi	—

Measure

Time frame

To assess the number of patients needed the rescue medicine therapy after 2 weeks of treatmentTimepoint: 2 weeks and 4 weeks;To evaluate the Adverse events in each arm, coded as per MedDRA, with topical preparations (Crisaborole Vs Tacrolimus Vs Steroid) in patients with mild to moderate Atopic DermatitisTimepoint: 2 weeks and 4 weeks;To evaluate the Change from baseline to 4 weeks in EASI (Eczema area and severity index) with topical preparations (Crisaborole Vs Tacrolimus Vs Steroid) in patients with mild to moderate Atopic DermatitisTimepoint: 2 weeks and 4 weeks;To evaluate the Change from baseline to 4 weeks in IGA (investigators global assessment) score with topical preparations (Crisaborole Vs Tacrolimus Vs Steroid) in patients with mild to moderate Atopic DermatitisTimepoint: 2 weeks and 4 weeks;To evaluate the Change from baseline to 4 weeks in PP-NRS (Peak Pruritus Numerical Rating Scale) with topical preparations (Crisaborole Vs Tacrolimus Vs Steroid) in patients with mild to moderate Atopic DermatitisTimepoint: 2 weeks and 4 weeks;To evaluate the Change from baseline to 4 weeks in QoL (Quality of life) with topical preparations (Crisaborole Vs Tacrolimus Vs Steroid) in patients with mild to moderate Atopic DermatitisTimepoint: 2 weeks and 4 weeks;To evaluate the Change from baseline to 4 weeks in SCORAD (Scoring Atopic Dermatitis) with topical preparations (Crisaborole Vs Tacrolimus Vs Steroid) in patients with mild to moderate Atopic DermatitisTimepoint: 2 weeks and 4 weeks;To evaluate the cost-effectiveness for the proportion of patients with treatment success (a score of 0 or 1 within the treatment area) based on the Investigator’s Global Assessment of Disease Severity (IGA) with topical preparations (Crisaborole Vs Tacrolimus Vs Steroid) in patients with mild to moderate Atopic DermatitisTimepoint: 2 weeks and 4 weeks;To evaluate the cost-utility based on quality of life with topical preparations (Crisaborole Vs Tacrolimus Vs Steroid) in patients wi

—

Countries

India

Contacts

Public ContactRakesh Dodiya

AIIMS, Jodhpur

dodiyarakesh2015@gmail.com7572813971

Outcome results

None listed

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