Ignite Creation Date:
2024-05-06 @ 9:58 AM
Last Modification Date:
2024-10-26 @ 12:22 PM
Study NCT ID:
NCT03123016
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2017-04-11
Brief Title:
Combined Therapy With Narrow-Band Ultraviolet B Phototherapy and Apremilast for the Treatment of Vitiligo
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
A Split Body Study of the Effects of Combined Therapy With Narrow-Band Ultraviolet B Phototherapy and Apremilast for the Treatment of Vitiligo
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Vitiligo is a common acquired disorder of pigmentation affecting 05 to 1 of the world population Sharply demarcated patches of depigmentation which can affect all ethnicities and can lead to cosmetic disfiguration and psychosocial distress characterize the disease The etiology of vitiligo remains unknown Various mechanisms have been proposed such as autoimmunity self-destruction biochemical genetic neural oxidative stress and an imbalance of epidermal cytokines leading to inflammation and selective loss of epidermal melanocytes Currently the most popular theory is autoimmunity Previous studies noted that around 25-30 of patients have at least one other autoimmune disease such as autoimmune thyroid disease Addisons disease pernicious anemia and alopecia areata Currently NB-UVB phototherapy is the most widely used therapeutic option for vitiligo affecting more than 10-20 of the skin surface as it is generally considered to be a safe initial treatment Potential side effects include phototoxic reaction thickening of the skin and koebnerization NB-UVB is a band of UV radiation with a wavelength of 311-313 nm UVB induces mitogenesis and migration in melanocytes mediated by several factors such as IL-1 TNF alpha and leukotriene C4 UV radiation produces increased number and activity of melanocytes increased melanin density elongation and branching of dendrites with increased transfer of more heavily melanized melanosomes to keratinocytes seen clinically as increased pigmentation Apremilast is an oral small molecule phosphodiesterase-4 PDE4 inhibitor that has been shown to regulate inflammatory mediators Apremilast enters cells by passive diffusion and once intracellular binds PDE4 PDE-4 the dominant phosphodiesterase expressed in immune cells degrades cyclic AMP cAMP into AMP PDE4 inhibition thereby elevates intracellular cAMP which can down-regulate the inflammatory responses such as TNF-α IFN-γ interleukins IL 2 12 and 23 through mechanisms such as partially inhibiting expression of inflammatory cytokines and increasing expression of anti-inflammatory mediators such as IL2 and IL10 The hypothesis is that apremilast will shut down the inflammatory insult in vitiligo and NB-UVB phototherapy will then be able to regenerate melanocytes and their activity By examination of skin biopsies taken pre- and post-therapy the study team aims to assess changes in immune and cellular markers in affected skin
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None