Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2026-01-03 @ 6:50 PM
Study NCT ID:
NCT05323292
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-17
First Post:
2022-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin A Status in Patients With Vocal Fold Leukoplakia
Sponsor:
University of Wisconsin, Madison
Organization:
Study Overview
Official Title:
Vitamin A Status in Patients With Vocal Fold Leukoplakia
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-12
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:
This study will determine systemic vitamin A status and lesion histopathology of participants with vocal fold hyperkeratosis resulting in clinical leukoplakia.
Detailed Description:
The investigator's overarching goal is to determine if there is a pathophysiologic rationale for vitamin A supplementation in the treatment of vocal fold hyperkeratosis. Vocal fold hyperkeratosis is an accumulation of epithelial surface keratin resulting in clinical leukoplakia. It is primarily managed using destructive techniques that risk iatrogenic injury, fibrosis, and voice impairment. Given the potential morbidity of biopsy and lesion removal, there is a need for new approaches to the prevention and treatment of vocal fold leukoplakic disorders that are non-destructive. Vitamin A is a key regulator of epithelial health and systemic vitamin A deficiency could directly contribute to hyperkeratosis. Based on vitamin A's importance to vocal fold stellate and epithelial cell biology and its direct relevance to vocal fold hyperkeratosis, this study will assess vitamin A status in participants with vocal fold hyperkeratosis. An association would suggest further study on the effects of vitamin A optimization and/or supplementation in patients with leukoplakia, as well as an adjuvant therapy in participants for whom surgical treatment is indicated.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: