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

March 7, 2025 updated by: Madiha Sajid, Dow University of Health Sciences

Comparison Between Apremilast in Combination with NBUVB and NBUVB Alone in Vitiligo - a Randomized Controlled Trial

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan
        • Dow International Medical College , DUHS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Apremilast with phototherapy
Combination product: Apremilast with NB-UVB
Tab Apremilast 30 mg twice a day with NBUVB twice per week for 8 months
Active Comparator: Phototherapy alone
Device: NB-UVB
NBUVB only will be given twice per week for 8 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the frequency of patients halted their progression and extent of repigmentation
Time Frame: 32 weeks

Halt in progression and extent of repigmentation from baseline to week 32 in both groups will be calculated by Scale named Vitiligo Area and Severity Index(VASI) done at the baseline and then at week 8, week 16, week 24 and 32.

Score of the scale ranges from 0 -100 . Fall in the score will show the improvement.
32 weeks
To determine the frequency of patients showing decrease in the percentage of depigmented areas
Time Frame: 32 weeks

This will be performed by calculating Body surface area (BSA ) at the baseline and at week 32 .

The patient's palmar surface including their fingers = 1% BSA Scale grading is as follows, mild (less than 3%) moderate (3-10%) severe (greater than 10%)

Fall in the percentage of depigmented area is taken as improvement .
32 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DLQI Score and Safety
Time Frame: 32 weeks

Dermatology Life Quality Index (DLQI) score at week 32 compared to baseline Scale ranges from 0 to 30 0 - 1 no effect at all, 2 - 5 small effect, 6 -10 moderate effect , 11 - 20 very large effect, 21 - 30 extremely large effect on the life of patient.

Decrease in the score will be a marker of improvement
32 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the tolerability and safety of intervention
Time Frame: 32 weeks
Documentation of Adverse Events during therapy
32 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dow University of Health Sciences

Investigators

  • Study Chair: Principal DIMC, Dow International Medical college

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

March 30, 2027

Study Registration Dates

First Submitted

September 5, 2024

First Submitted That Met QC Criteria

September 10, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 7, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIMC/DUHS/DERMA/001/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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