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Open labelled, single arm, interventional study of Apremilast in childhood dermatosis

Apremilast in childhood dermatoses

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/03/041201
Enrollment
15
Registered
2022-03-21
Start date
Unknown
Completion date
Unknown
Last updated
2022-11-21

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

Conditions

Health Condition 1: L639- Alopecia areata, unspecified Health Condition 2: L209- Atopic dermatitis, unspecified Health Condition 3: L439- Lichen planus, unspecified Health Condition 4: L409- Psoriasis, unspecified Health Condition 5: L80- Vitiligo

Interventions

Intervention1: Apremilast 20MG & 30MG Tablet: Apremilast 20MG twice daily (age, 6-11 years and weight â?¥15 kg) Apremilast 30MG twice daily (age, 12-17 years and weight â?¥35 kg) Control Intervention1

Sponsors

CUTIS Academy of Cutaneous Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Children between age of 6-17 years 2.Confirmed dermatological diseases (psoriasis, vitiligo, alopecia areata, atopic dermatitis) 3.Both male and female children will be recruited 4.Parents willing to provide written informed consent

Exclusion criteria

Exclusion criteria: 1.History of any chronic systemic disease 2.History of any congenital anomaly 3.Patients with active infection 4.Participated in a clinical trial in last 90 days 5.Parents not willing to provide written informed consent

Design outcomes

Primary

MeasureTime frame
Effect assessed in terms of decrease in the disease activity clinically and/or dermoscopically.Timepoint: After 4 months

Secondary

MeasureTime frame
ï?· Patient satisfaction with treatment will be assessed based on a Grading questionnaire ï?· Patient compliance will be assessed based on completed patient diary and compliance assessment during study visits ï?· Safety will be assessed based on the adverse reactions reported during the study period.Timepoint: After 4 months

Countries

India

Contacts

Public ContactDr Rashmi Agarwal

CUTIS Academy of Cutaneous Sciences

agarwal5rashmi@gmail.com9707778021

Outcome results

None listed

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