Vitiligo Clinical Trial
— TILDVIT-1227Official title:
Pilot Study Assessing the Effect of Tildrakizumab in Vitiligo
Verified date | October 2023 |
Source | Premier Specialists, Australia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Vitiligo is a common acquired depigmentation disorder affecting approximately 2% of the world population. The purpose of this pilot study is to evaluate the effect and the safety of Tildrakizumab in adult participants with vitiligo.
Status | Active, not recruiting |
Enrollment | 12 |
Est. completion date | April 2024 |
Est. primary completion date | April 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 18 years of age or older - Diagnosis of vitiligo - Clinically stable vitiligo: defined as no new vitiligo patches and no enlargement of existing patches in previous 3 months. - Able to provide voluntary, written, informed consent Exclusion Criteria: - Clinically active vitiligo: defined as new vitiligo patches or enlargement of existing patches in previous 3 months - Concurrent skin disease in the study area - Immunocompromise - Women of childbearing potential (WOCBP) who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 12 weeks after the last dose. |
Country | Name | City | State |
---|---|---|---|
Australia | Premier Specialists Pty Ltd | Sydney | New South Wales |
Lead Sponsor | Collaborator |
---|---|
Premier Specialists, Australia |
Australia,
Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x. — View Citation
Hamzavi I, Jain H, McLean D, Shapiro J, Zeng H, Lui H. Parametric modeling of narrowband UV-B phototherapy for vitiligo using a novel quantitative tool: the Vitiligo Area Scoring Index. Arch Dermatol. 2004 Jun;140(6):677-83. doi: 10.1001/archderm.140.6.677. — View Citation
Hu Y, Qi X, Hu Y, Lu Y, Liu K, Han X, Mao Z, Wu Z, Zhou X. Effects of CO2 fractional laser therapy on peripheral blood cytokines in patients with vitiligo. Dermatol Ther. 2019 Jul;32(4):e12992. doi: 10.1111/dth.12992. Epub 2019 Jun 17. — View Citation
Jerjen R, Moodley A, Sinclair R. Repigmentation of acrofacial vitiligo with subcutaneous tildrakizumab. Australas J Dermatol. 2020 Nov;61(4):e446-e448. doi: 10.1111/ajd.13346. Epub 2020 May 21. No abstract available. — View Citation
Vaccaro M, Cannavo SP, Imbesi S, Cristani M, Barbuzza O, Tigano V, Gangemi S. Increased serum levels of interleukin-23 circulating in patients with non-segmental generalized vitiligo. Int J Dermatol. 2015 Jun;54(6):672-4. doi: 10.1111/ijd.12392. Epub 2014 Nov 27. — View Citation
van Geel N, Lommerts J, Bekkenk M, Wolkerstorfer A, Prinsen CAC, Eleftheriadou V, Taieb A, Picardo M, Ezzedine K, Speeckaert R. Development and Validation of the Vitiligo Extent Score (VES): an International Collaborative Initiative. J Invest Dermatol. 2016 May;136(5):978-984. doi: 10.1016/j.jid.2015.12.040. Epub 2016 Jan 28. — View Citation
van Geel N, Lommerts JE, Bekkenk MW, Prinsen CA, Eleftheriadou V, Taieb A, Picardo M, Ezzedine K, Wolkerstorfer A, Speeckaert R; international Vitiligo Score Working Group. Development and validation of a patient-reported outcome measure in vitiligo: The Self Assessment Vitiligo Extent Score (SA-VES). J Am Acad Dermatol. 2017 Mar;76(3):464-471. doi: 10.1016/j.jaad.2016.09.034. Epub 2016 Nov 22. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage repigmentation: Vitiligo Area Scoring Index (VASI) | Percentage repigmentation is assessed through change in score from baseline. Range 0-100. Higher score=greater depigmentation/worse | Week 24 | |
Primary | Percentage repigmentation: Vitiligo Extent Score (VES) | Percentage repigmentation is assessed through change in score from baseline. Range 0-100. Higher score=greater depigmentation/worse | Week 24 | |
Primary | Percentage repigmentation: Photographs | Percentage repigmentation is assessed through comparison of photographs of vitiligo lesions from baseline. | Week 24 | |
Secondary | Percentage repigmentation: Vitiligo Area Scoring Index (VASI) | Percentage repigmentation is assessed through change in score from baseline. Range 0-100. Higher score=greater depigmentation/worse | Week 12 | |
Secondary | Percentage repigmentation: Vitiligo Extent Score (VES) | Percentage repigmentation is assessed through change in score from baseline. Range 0-100. Higher score=greater depigmentation/worse | Week 12 | |
Secondary | Percentage repigmentation: Photographs | Percentage repigmentation is assessed through comparison of photographs of vitiligo lesions from baseline. | Week 12 | |
Secondary | Time to repigmentation | through study treatment completion at 24-weeks | ||
Secondary | Change in Quality of Life score from baseline: Dermatology Life Quality Index (DLQI) | Used to assess treatment response on subject's quality of life. Range 0-30. Higher score=larger effect on patient's life/worse | Baseline through week 12 and through study treatment completion at 24-weeks | |
Secondary | Change in Quality of Life score from baseline: Patient Global Impression of Change (PGIC) | 1-tem questionnaire designed to assess a subject's impression of disease improvement. 7 point Likert scale ranging from "Very much better" to "Very much worse" with "no change" in the middle. Range[1-no change, 2-almost the same, 3-a little better, 4-somewhat better, 5-moderately better, 6-better/a definite improvement, 7-a great deal better]. Higher score=better impression of change/better | Baseline through week 12 and through study treatment completion at 24-weeks | |
Secondary | Change in Quality of Life score from baseline: Self-Assessment Vitiligo Extent Score (SA-VES) | Validated patient reported outcome measurement to provide information about disease extent and repigmentation. Range 0-100. Higher score=greater depigmentation/worse. | Baseline through week 12 and through study treatment completion at 24-weeks | |
Secondary | Adverse events | incidence and nature of any adverse events | through study treatment completion at 24-weeks |
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