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

NCT06593197 | Enrolling By Invitation Phase 4

• 1 other identifier: DIMC/DUHS/DERMA/001/2024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (2)

• To determine the frequency of patients halted their progression and extent of repigmentation

  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

  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 Outcomes (1)

• DLQI Score and Safety

  32 weeks

Other Outcomes (1)

• To determine the tolerability and safety of intervention

  32 weeks

Study Arms (2)

Apremilast with phototherapy

EXPERIMENTAL

Phototherapy alone

ACTIVE COMPARATOR

Device: NB-UVB

Interventions

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

Phototherapy alone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients age 18 years and above
• Patients of both genders (male and female)
• Diagnosed patients of non-segmental vitiligo involving \> 5% of BSA

You may not qualify if:

• 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

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dow International Medical College , DUHS

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Vitiligo

Interventions

apremilast

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Principal DIMC

  Dow International Medical college

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: March 11, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)