Clinical trial NCT06593197: Efficacy and Safety of Apremilast in Combination with NBUVB and NBUVB Alone in Vitiligo Patients
Official title: Comparison Between Apremilast in Combination with NBUVB and NBUVB Alone in Vitiligo - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Vitiligo
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients of non-segmental vitiligo, fulfilling the inclusion criteria will be selected from the OPD, dermatology department. It\&#39;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 \&gt; 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.

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

Primary outcomes:
measure: To determine the frequency of patients halted their progression and extent of repigmentation
timeFrame: 32 weeks
measure: To determine the frequency of patients showing decrease in the percentage of depigmented areas
timeFrame: 32 weeks
Secondary outcomes:
measure: DLQI Score and Safety
timeFrame: 32 weeks
Other outcomes:
measure: To determine the tolerability and safety of intervention
timeFrame: 32 weeks
Locations:
city: Karachi
country: Pakistan
facility: Dow International Medical College , DUHS
state: Sindh
Study officials:
affiliation: Dow International Medical college
name: Principal DIMC
role: STUDY_CHAIR
References: