Effectiveness and safety of crisaborole ointment versus betamethasone valerate cream in atopic dermatitis: randomized controlled trial in a tertiary care centre of eastern India

Effectiveness and safety of crisaborole 2% ointment versus betamethasone valerate 0.1% cream in atopic dermatitis: observer-blind non-inferiority randomized controlled trial in a tertiary care centre of eastern India - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/066119

Enrollment

Registered

2024-04-23

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

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: Crisaborole 2% ointment twice daily topical application for 4 weeks Control Intervention1: Betamethasone valerate 0.1% cream: Betamethasone valerate 0.1% cream

Eligibility

Inclusion criteria

Inclusion criteria: 1. Atopic dermatitis patients diagnosed by Hanifin and Rajka criteria. 2. Age more than 5 yrs up to 80 years.

Exclusion criteria

Exclusion criteria: 1. Patients with erythroderma resulting from atopic dermatitis. 2. Those receiving any other immunosuppressives or immunomodulators. 3. Known cases of chronic liver and kidney diseases. 4. Eczema herpeticum cases. 5. Patients with psychiatric disorders. 6. Participation in any clinical trial within the last 3 months. 7. Non-consenting patients or parents.

Design outcomes

Primary

Measure	Time frame
Effectiveness and safety of crisaborole 2% ointment is not inferior to betamethasone valerate 0.1% cream in treatment of atopic dermatitis measured in terms of scoring indicesTimepoint: 4 weeks	—

Secondary

Measure	Time frame
To assess the comparative change in quality of life with treatment in both the groups.Timepoint: 4 weeks;To assess whether there is any difference in the effectiveness and safety of crisaborole 2% ointment among children, adolescent and adults.Timepoint: 8 weeks.;To evaluate the effectiveness and safety of crisaborole 2% ointment in comparison with betamethasone valerate 0.1% cream as maintenance therapy in prevention of atopic dermatitis.Timepoint: 4 weeks	—

Measure

Time frame

To assess the comparative change in quality of life with treatment in both the groups.Timepoint: 4 weeks;To assess whether there is any difference in the effectiveness and safety of crisaborole 2% ointment among children, adolescent and adults.Timepoint: 8 weeks.;To evaluate the effectiveness and safety of crisaborole 2% ointment in comparison with betamethasone valerate 0.1% cream as maintenance therapy in prevention of atopic dermatitis.Timepoint: 4 weeks

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Countries

India

Contacts

Public ContactDr. Arghyaprasun Ghosh

Bankura Sammilani Medical College

arghyap_ghosh@yahoo.com8617792187

Outcome results

None listed

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