VitiligoPhase 4NCT06593197
Efficacy and Safety of Apremilast in Combination with NBUVB and NBUVB Alone in Vitiligo Patients
A Phase 4 study testing Apremilast with NB-UVB and NB-UVB in people with Vitiligo, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- Apremilast with NB-UVB and NB-UVB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2025to 30 Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age 18 years and above
- Patients of both genders (male and female)
- Diagnosed patients of non-segmental vitiligo involving > 5% of BSA
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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
- Being tested
- Apremilast with NB-UVB, NB-UVB
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apremilast with NB-UVBCombination product
Tab Apremilast 30 mg twice a day with NBUVB twice per week for 8 months
NB-UVBDevice
NBUVB only will be given twice per week for 8 months
| Study group | Role | What they receive |
|---|---|---|
| Apremilast with phototherapy | Experimental | Not described |
| Phototherapy alone | Active comparator | Not described Receives: Device: NB-UVB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 .
Measured: 32 weeks
Secondary outcomes (1)
DLQI Score and Safety
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
Measured: 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jan 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madiha Sajid, Dow University of Health Sciences
- Investigators
- Principal DIMC, Study chair, Dow International Medical college
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593197
- Sponsor's protocol ID
- DIMC/DUHS/DERMA/001/2024
- Status last verified
- Jan 2025
- First submitted
- 5 Sep 2024
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Apremilast in Combination with NBUVB and NBUVB Alone in Vitiligo - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06593197
- Acronym / sponsor ID
- DIMC/DUHS/DERMA/001/2024
- Conditions
- Vitiligo
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apremilast with phototherapy | Experimental | – |
| Phototherapy alone | Active comparator | Device: NB-UVB |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients age 18 years and above
- Patients of both genders (male and female)
- Diagnosed patients of non-segmental vitiligo involving > 5% of BSA
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apremilast with NB-UVBTab Apremilast 30 mg twice a day with NBUVB twice per week for 8 months | Combination product | – |
| NB-UVBNBUVB only will be given twice per week for 8 months | Device | Phototherapy alone |
Primary outcome
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.
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 .
1 secondary outcome
DLQI Score and Safety
Time frame: 32 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Principal DIMC study chair
Dow International Medical college
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Apremilast with NB-UVB and NB-UVB in people with Vitiligo, run by Dow University of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the frequency of patients halted their progression and extent of repigmentation (time frame: 32 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.