Health Condition 1: L80- Vitiligo
Conditions
Interventions
Intervention1: Ruxolitinib cream, 1.5%: To be applied twice daily (morning and evening) from Baseline to Week 24
Control Intervention1: Deca-Peptide solution, 1 mg/mL: To be applied at night 2 hours p
Sponsors
Sun Pharmaceutical Industries Limited (SPIL)
Sun Pharmaceutical Industries Limited
Eligibility
Inclusion criteria
Inclusion criteria: Patient will be included if all the inclusion criteria listed below are met: 1. Patients of either gender with age between 18 to 65 years (both inclusive) and willing to provide written informed consent 2. Patients with a body mass index (BMI) of 18.5 to 40 Kg per m2 (both inclusive) 3. Patients with a confirmed clinical diagnosis of non-segmental vitiligo and fulfilling the following criteria at Screening: a) The depigmented area on the face should be greater than or equal to 0.5% BSA (F-BSA) b) Facial Vitiligo Area Scoring Index (F-VASI) score of greater than or equal to 0.5 c) The depigmented area on non-facial areas should be greater than or equal to 3% BSA d) Total Body Vitiligo Area Scoring Index (T-VASI) score of greater than or equal to 3 e) Total body vitiligo area (facial and non-facial) lesser than or equal to 10% BSA (T-BSA) f) Stable vitiligo (without any new lesions or progression of existing lesions in last 6 months) 4. Participants who agree to discontinue all agents used to treat vitiligo from Screening through the final safety follow-up visit [Note: camouflage makeups are permitted] 5. Women of childbearing potential must have a negative urine pregnancy test prior to Screening and Randomization and agree to use highly effective methods of contraception to prevent pregnancy from study entry till end of study (such contraception may include hormonal birth control e.g. combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or total sexual abstinence OR non-hormonal contraception [e.g. condoms with spermicide]) [Note: Women with childbearing potential are defined as: those who are not (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal. Post-menopausal woman will be defined as: Woman not using hormonal replacement therapy and have had at least 12 continuous months of natural (spontaneous) amenorrhea and be greater than 45 years of age] 6. Male patients must have had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the criteria above (i.e., not of childbearing potential or practicing highly effective contraception throughout the study period) [No sperm donation is allowed during the study period]
Exclusion criteria
Exclusion criteria: Patients will be excluded if any of the exclusion criteria listed below is met: 1. Patients having hypersensitivity or any other contraindication to any of the Investigational products or any of their components 2. Patients with other forms of vitiligo (e.g., segmental) or other differential diagnosis of vitiligo or other skin depigmentation disorders 3. Patients with history of previous depigmentation treatments (e.g., monobenzone) [Note: Prior use of hydroquinone is allowed] 4. Patients with history of any other skin disorder, that in the opinion of Investigator, would interfere with the study medication application or study assessments 5. Patients with history of active acute bacterial/ fungal/ viral skin infection (for example but not limited to: herpes simplex, herpes zoster, chicken pox) within 1 week before Screening 6. Patients with history of chronic or recurrent systemic infection within 6 months prior to Screening 7. Patient with history of active pulmonary or extra-pulmonary tuberculosis within 1 year prior to Screening OR a positive report on QuantiFERON TB Gold test at Screening 8. Patients with history of invasive fungal infection (including cryptococcosis and pneumocystosis) or any other opportunistic infection or any immunocompromised disorder/ condition 9. Patients with history of live/ live attenuated vaccination within 4 weeks prior to Screening or planning for vaccination during the course of the study or within 4 weeks after study completion 10. Patients with history of prior treatment with Janus Kinase (JAK) inhibitors (systemic or topical) for inflammatory conditions 11. Patients using any of the following drugs/ treatments: a. Topical agents for vitiligo areas (including but not limited to: corticosteroids, calcineurin inhibitors, phosphodiesterase type 4 (PDE4) inhibitors, retinoids) [Note: Patients can be included after 1 week of washout period] b. Systemic immunomodulating agents (like corticosteroids, methotrexate, cyclosporine, etc.), melanocyte-stimulating agents (like afamelanotide), other systemic therapies which may lead to photosensitivity of skin or impact skin pigmentation (like tetracyclines, metoxypsoralens, etc.) [Note: Patients can be included after 4 weeks of washout period] c. Any type of Laser or Phototherapy [Note: Patients can be included if they have completed 8 weeks of washout period prior to Randomization visit] d. Biological agents for treatment of vitiligo [Note: Patients can be included if they have completed 12 weeks or 5 half-lives (whichever is longer) of washout period prior to Randomization visit] [Note: Maximum washout period allowed within the study (i.e., after Screening visit) is for 4 weeks. If the patient requires washout more than 4 weeks after screening, then such patients will be excluded from the study] 12. Pregnant and/or lactating female 13. Patient who tested positive for human immunodeficiency virus (HIV) and/or history of hepatitis B virus (HBV) infection and/or history of hepatitis C virus (HCV) infection at Screening 14. Patients with history of any malignancy in the last 5 years prior to Screening or undergoing cancer chemo or radiotherapy 15. Patients with known alcohol or other substance abuse within last one year prior to Screening 16. Patients who have participated in another Investigational study within the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Percentage change from baseline in F-VASI Timepoint: Baseline and Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage change from baseline in F-BSATimepoint: Baseline and Week 24;Proportion of patients achieving greater than or equal to 50% improvement from baseline in the T-VASITimepoint: Week 24;Proportion of overall responders on Total Patient s Global Impression of Change - Vitiligo (T-PGIC-V) who have a response of very much improved (1) or much improved (2)Timepoint: Week 24;Change from baseline in DLQI total scoreTimepoint: Baseline and Week 24;Proportion of patients achieving greater than or equal to 75% improvement from baseline in the F-VASITimepoint: Week 24;Proportion of patients achieving greater than or equal to 50% improvement from baseline in the F-VASITimepoint: Week 24;Proportion of patients achieving greater than or equal to 90% improvement from baseline in the F-VASITimepoint: Week 24 | — |
Countries
India
Contacts
Public ContactDr Rajiv Yadav
Sun Pharma Laboratories Limited
Outcome results
None listed