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Enrolling by Invitation

NCT Number: NCT06593197

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

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.

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Key information

Conditions

Vitiligo Hypopigmentation Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dow International Medical College , DUHS

Karachi, Sindh, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apremilast with NB-UVB

Combination Product

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

NB-UVB

Device

NBUVB only will be given twice per week for 8 months

Primary outcomes

  1. 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.

  2. 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 .

Secondary outcomes

  1. 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

Other outcomes

  1. To determine the tolerability and safety of intervention

    Time frame: 32 weeks

    Documentation of Adverse Events during therapy

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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