Comparison of side effects when Apremilast doses are increased weekly versus daily.

Comparison of the side effect profiles of weekly versus daily dose escalation of Apremilast: A randomized trial - NA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/097386

Enrollment

130

Registered

2025-11-13

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

None listed

Interventions

Intervention1: weekly dose escalation: apremialst weekly dose escalation for seven weeks Control Intervention1: daily esacalation group: daily escalation of apremilast until 30 mg twice daily, followe

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 18 years or older with dermatological conditions for whom apremilast is indicated.

Exclusion criteria

Exclusion criteria: 1. Patients who are taking other concurrent systemic therapy for dermatological conditions. 2. Patients who are not willing to participate. 3. Patients who are below 18 years of age. 4. Patients with coexisting GI conditions and migraine. • Patients who have an allergy or record of intolerance to apremilast or have any contraindications for use of apremilast. • Pregnant and breastfeeding women

Design outcomes

Primary

Measure	Time frame
Primary outcomes: •Incidence of gastrointestinal side effects (nausea, diarrhoea) and headache. Timepoint: at week 2 and week 7	—

Secondary

Measure	Time frame
• Adherence rate of the Apremilast in both the weekly and daily escalation groups.Timepoint: at week 2 and week 7	—

Countries

India

Contacts

Public ContactAKSHAY SANKAR PEETHAMBARAN

AIIMS RAIPUR

akshaysankar47@gmail.com7749996506

Outcome results