Evaluation of effective and safe use of a new drug Apremilast [a Phosphodiesterase enzyme inhibitor (PDE-4 inhibitor)] in patients suffering from unstable white patch-a skin condition called vitiligo.
Phase 2
- Conditions
- Health Condition 1: L80- Vitiligo
- Registration Number
- CTRI/2019/07/020234
- Lead Sponsor
- AIIMS JODHPUR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1)Subjects with non-segmental, unstable vitiligo.
2)Unstable vitiligo: Occurrence of new patch/progression of existing patch/presence of Koebner phenomenon in cases with vitiligo for 6 months.
3) In general good health (except vitiligo), based on medical history, physical examination.
Exclusion Criteria
1. Clinically significant (as determined by the clinician) or other major uncontrolled diseases that will affect the health of the subject during the study or interfere with the interpretation of study results (such as migraine/IBD/IBS etc).
2. Cases with only acrofacial vitiligo.
3. Pregnant & Breastfeeding females.
4. Any known allergy with apremilast.
5. Cases on any drug with pigmentation potential.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To estimate the change in the proportion of responders to add on Apremilast from baseline to week 12.Timepoint: 0,2,4,8,12 weeks.
- Secondary Outcome Measures
Name Time Method 1. To investigate the change in Body Surface Area (BSA) of vitiligo at week 12. <br/ ><br>2. To investigate change in VASI score - Vitiligo Area and Severity Index score at week 12. <br/ ><br>3.To investigate the Dermatology Life Quality Index (DLQI) at week 12. <br/ ><br>4. To investigate the Visual Analogue Scale (VAS) at week 12. <br/ ><br>5. To investigate the Number of Adverse Events in 12 weeks.Timepoint: 0,2,4,8,12 Weeks.