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.

Study of Efficacy and Safety of add on Apremilast in patients with Unstable Vitiligo.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/07/020234

Enrollment

Registered

2019-07-17

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L80- Vitiligo

Interventions

Intervention1: APREMILAST: Tablet Apremilast will be given by oral route for the duration of 90 days. Dose titration will be done for first 6 days which is as follows: Day 1 - 10mg (morning). Day 2 -

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1. To investigate the change in Body Surface Area (BSA) of vitiligo at week 12. 2. To investigate change in VASI score - Vitiligo Area and Severity Index score at week 12. 3.To investigate the Dermatology Life Quality Index (DLQI) at week 12. 4. To investigate the Visual Analogue Scale (VAS) at week 12. 5. To investigate the Number of Adverse Events in 12 weeks.Timepoint: 0,2,4,8,12 Weeks.	—

Countries

India

Contacts

Public ContactSAKSHI SHARMA

ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR

dr.prad99@gmail.com8003996952

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026