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NCT03123016 · ClinicalTrials.gov registry record · Phase 2
Combined Therapy With Narrow-Band Ultraviolet B Phototherapy and Apremilast for the Treatment of Vitiligo
A Phase 2 study of Vitiligo, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
- 1
- Study location
NCT03123016: Completed Phase 2 study of Vitiligo, sponsored by Icahn School of Medicine at Mount Sinai.
NCT03123016 is a Phase 2 study of Vitiligo that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 23 participants, below the 1,123-participant average among 15 other Vitiligo trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03123016, a Phase 2 study of Vitiligo, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
- 1
- Study location
Study Summary
Vitiligo is a common acquired disorder of pigmentation affecting 0.5% 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, Addison's 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
Primary Outcome
The proportion of responders to apremilast plus concomitant NB-UVB at week 32 compared to the proportion of responders to NB-UVB phototherapy at week 16.
Conditions Studied
Interventions
- DRUG Apremilast
- PROCEDURE NB-UVB phototherapy
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2017-04-14 |
| Est. Completion | 2019-08-05 |
| Phase | Phase 2 |
What the finished NCT03123016 record still lists
NCT03123016 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 1,123-participant average among 15 other Vitiligo trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Vitiligo appearing as the primary indexed condition, and to 2 interventions - of which Apremilast is the first listed.
NCT03123016 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03123016 about?
NCT03123016 is a clinical study titled "Combined Therapy With Narrow-Band Ultraviolet B Phototherapy and Apremilast for the Treatment of Vitiligo". Vitiligo is a common acquired disorder of pigmentation affecting 0.5% 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 re...
What is the current status of trial NCT03123016?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2017-04-14. Estimated completion is 2019-08-05.
What conditions does trial NCT03123016 study?
This clinical trial studies the following conditions: Vitiligo.
What interventions are being tested in trial NCT03123016?
The interventions under investigation include: Apremilast (DRUG), NB-UVB phototherapy (PROCEDURE).
Who is sponsoring clinical trial NCT03123016?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03123016 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Vitiligo
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03123016's enrollment target sits among peer trials
23 12th of 15 higher than 4 of 15 other Vitiligo trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Vitiligo trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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