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

NCT ID: NCT06593197

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2027-03-30

Brief Summary

Patients of non-segmental vitiligo, fulfilling the inclusion criteria will be selected from the OPD, dermatology department. It's an interventional study where Group A patient will be given NBUVB and Tab Apremilast 30 mg twice a day and Group B will receive NBUVB alone.

Detailed Description

Patients of non-segmental vitiligo, fulfilling the inclusion criteria will be selected from the OPD, dermatology department Dow university hospital. Informed consent will be obtained from all the patients.

Demographic details of patients including age, gender, education, occupation and marital status will be obtained. Further each patient will be asked about duration of vitiligo and any systemic medications used by the patients in the last 6 months will be recorded.

Body Surface Area will be calculated and patients with > 5% of BSA will be included in the study.

Subjects will be randomly divided by lottery method into two groups. Group A patients will be given NBUVB and Tab Apremilast 30 mg twice a day, and Group B patients will receive NBUVB alone.

Hematological baseline including CBC and LFTs will be advised to patients in Group A.

Vitiligo Area Severity Index (VASI) will be used to initially assess the patient at the baseline and later on to assess the regimentation in each of the patients of vitiligo on next 4 follow-ups. Each follow-up will be after every 8 weeks for a total of 32 weeks. CBC and LFTs will be repeated in Group A after 4 weeks of starting tab Apremilast 30 mg BD and then after 3 months. Any side effects seen during the study period will be recorded and managed accordingly DLQI Dermatological Life Quality Index (DLQI) questionnaire will be conducted with 30 vitiligo patients at the baseline and at the end of therapy.

All results will be collected and filled in proforma by the researcher. The results will be assessed statistically at the end of the follow-up period.

Conditions

Vitiligo

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Apremilast with phototherapy

Group Type: EXPERIMENTAL

No interventions assigned to this group

Phototherapy alone

Group Type: ACTIVE_COMPARATOR

NB-UVB

Intervention Type: DEVICE

NBUVB only will be given twice per week for 8 months

Interventions

Apremilast with NB-UVB

Tab Apremilast 30 mg twice a day with NBUVB twice per week for 8 months

Intervention Type: COMBINATION_PRODUCT

NB-UVB

NBUVB only will be given twice per week for 8 months

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dow University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Madiha Sajid

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Principal DIMC

Role: STUDY_CHAIR

Dow International Medical college

Locations

Dow International Medical College , DUHS

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

DIMC/DUHS/DERMA/001/2024

Identifier Type: -

Identifier Source: org_study_id