Efficacy and Safety of Apremilast in Combination with NBUVB and NBUVB Alone in Vitiligo Patients

Launched by DOW UNIVERSITY OF HEALTH SCIENCES · Sep 10, 2024

Keywords

ClinConnect Summary

This is a Phase 4 randomized trial at Dow University of Health Sciences in Karachi, Pakistan, studying whether adding the drug apremilast to standard narrowband UVB phototherapy helps adults with non-segmental vitiligo more than phototherapy alone. About 30 adults aged 18 to 70 who have vitiligo affecting more than 5% of their body will be invited to participate. Participants are randomly assigned to two groups: one receives apremilast (30 mg twice daily) plus NB-UVB phototherapy twice a week, and the other receives NB-UVB phototherapy alone, for about 8 months.

Participants will be followed for 32 weeks, with visits every 8 weeks to measure changes in vitiligo using the Vitiligo Area and Severity Index (VASI), the percentage of depigmented skin (body surface area), and quality of life (DLQI). Safety will be monitored by recording adverse events, and blood tests (CBC and liver tests) are planned for those taking apremilast. Key eligibility includes adults 18–70 with non-segmental vitiligo involving more than 5% BSA, while exclusions include pregnancy, active infections such as tuberculosis, a history of skin cancer, recent apremilast use, or recent phototherapy. If you’re considering participation, you’d join a trial still enrolling by invitation, with completion expected in 2027. The study is led by the Dow University team and uses a randomized, open-label design.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients age 18 years and above
• • Patients of both genders (male and female)
• • Diagnosed patients of non-segmental vitiligo involving \> 5% of BSA
• Exclusion Criteria:
• • Pregnant and lactating women
• • Concomitant active infection like tuberculosis
• • Personal history of cutaneous malignancy
• • Use of apremilast in the past 4 weeks
• • Use of phototherapy within 4 weeks before randomization