Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06593197
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
Efficacy and Safety of Apremilast in Combination with NBUVB and NBUVB Alone in Vitiligo Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison Between Apremilast in Combination with NBUVB and NBUVB Alone in Vitiligo - a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients of non-segmental vitiligo fulfilling the inclusion criteria will be selected from the OPD dermatology department It39s 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None