Health Condition 1: L80- Vitiligo
Conditions
Interventions
Intervention1: Vitizene gel: Dosage form: Gel, Route of administration: Topical, Dosage: Use twice a day on affected Vitiligo lesions, Duration:84 days.
Control Intervention1: Nil: Nil
Sponsors
Invex Health Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Confirmed diagnosis of vitiligo by a qualified dermatologist / investigator. 2.Individuals with non-segmental or generalized vitiligo. 3.Individuals with disease stability or minimal recent activity (no new lesions or expansion of existing lesions in the last 6 12 months). 4.Either male or female age between 18 and 75 years old (inclusive). 5.Willingness and ability to comply with study procedures. 6.Informed consent obtained, including explicit consent for photography and for use of photos in aggregate/for internal analyses (with data anonymization). 7. Throughout the entire research process, the participants agreed to stop using all treatments related to vitiligo as well as any cosmetic products with therapeutic effects.
Exclusion criteria
Exclusion criteria: 1.Individuals with segmental vitiligo, mixed vitiligo, or other forms. 2.Other dermatological conditions that can cause hypopigmentation/depigmentation such as chemical leukoderma, post-inflammatory hypopigmentation, pityriasis alba, nevus depigmentosus, albinism, other congenital or acquired pigment disorders. 3.Recent or ongoing treatment for vitiligo (topical, systemic, phototherapy, surgical, cell-based) within last 3 6 months. 4.Known or suspected history of immunosuppression. 5.Tuberculosis (TB) or latent tuberculosis infection. 6.Positive for human immunodeficiency virus antibody HIV-Ab, positive for syphilis-specific antibody, positive for hepatitis C virus antibody HCV-Ab, or hepatitis B virus (HBV) infection. 7.Pregnant or lactating women, or women planning pregnancy during the study period. 8.History of skin malignancy or other serious dermatological disease or active skin disease like psoriasis or eczema. 9.Inability to adhere to protocol or unwillingness to consent for photographic documentation. 10.Any comorbidity that may interfere with assessments or pose increased risk (e.g., uncontrolled systemic disease, immunosuppressive conditions, bleeding disorders). 11.Known hypersensitivity to any component of Vitizene severe psychiatric illness affecting consent or compliance. 12.Participation in another interventional clinical trial for vitiligo concurrently or within a defined washout period, to avoid overlapping interventions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in F-VASI 2. Change in T-VASI 3. Photographic evidence of appearance improvement.Timepoint: Day 0 to Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Investigator Global Assessment (IGA) of pigmentation. 2. Subject satisfaction and self-perceived improvement scores. 3.To assess adverse events or local skin reactions. Timepoint: Day 0 to Day 84;Safety Outcomes: 1.Incidence and severity of adverse events related to IP. 2. Changes in vital signs and laboratory parameters. 3. Any serious adverse events or discontinuations.Timepoint: Screening visit to Day 84 | — |
Countries
India
Contacts
Public ContactDr Ashok Godavarthi
Radiant Research Services Pvt Ltd
Outcome results
None listed