Ignite Creation Date:
2025-12-18 @ 8:13 AM
Ignite Modification Date:
2025-12-23 @ 9:19 PM
Study NCT ID:
NCT05513924
Status:
None
Last Update Posted:
2023-07-11 00:00:00
First Post:
2022-08-20 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Study Between Topical 5-fluorouracil and Latanoprost in Vitiligo.
Sponsor:
None
Organization:
Study Overview
Official Title:
Efficacy of Topical 5-fluorouracil Versus Topical Latanoprost With Microneedling in Localized Stable Vitiligo: A Randomised Clinical Trial
Status:
None
Status Verified Date:
2023-07
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 an acquired pigmentary disorder characterized by depigmented macules and patches secondary to the loss of functional melanocytes. It is a chronic disease that affects between 0.1% and 2% of the general population, affecting both sexes and all races.
Theories regarding loss of melanocytes are based on autoimmune, cytotoxic, oxidant-antioxidant and neural mechanisms.
Therapeutic strategies for vitiligo include nonsurgical and surgical methods. Nonsurgical options include topical corticosteroids and topical calcineurin inhibitors. Phototherapy as psoralen and ultraviolet A (PUVA) and narrow-band ultraviolet B (NB-UVB).
Two types of surgical techniques are available: tissue grafts and cellular grafts, within between autologous cultured epithelial grafts.
Microneedling is a method of transdermal drug delivery using a microneedling device applied to the skin for creating transport pathways through the stratum corneum, increasing the absorption of drugs and decreasing the duration of therapy. In addition, microneedling keeps the epidermis partially intact, fastens recovery, and limits the risk of infection and scarring. 5-Fluorouracil (5-FU) is a chemotherapeutic agent used in the treatment of many malignant tumors and it has been approved for topical use in the treatment of several dermatologic disorders. Localized hyperpigmentation occurred as a side effect of 5-FU use in cancer treatment attracts the attention toward its application in inducing repigmentation in vitiligo patches.
Latanoprost (LT), a prostaglandin F2 alpha analogue used in the treatment of glaucoma, was found to induce skin pigmentation in guinea pigs in addition to its known periocular and iridal pigmentation side effect.
Theories regarding loss of melanocytes are based on autoimmune, cytotoxic, oxidant-antioxidant and neural mechanisms.
Therapeutic strategies for vitiligo include nonsurgical and surgical methods. Nonsurgical options include topical corticosteroids and topical calcineurin inhibitors. Phototherapy as psoralen and ultraviolet A (PUVA) and narrow-band ultraviolet B (NB-UVB).
Two types of surgical techniques are available: tissue grafts and cellular grafts, within between autologous cultured epithelial grafts.
Microneedling is a method of transdermal drug delivery using a microneedling device applied to the skin for creating transport pathways through the stratum corneum, increasing the absorption of drugs and decreasing the duration of therapy. In addition, microneedling keeps the epidermis partially intact, fastens recovery, and limits the risk of infection and scarring. 5-Fluorouracil (5-FU) is a chemotherapeutic agent used in the treatment of many malignant tumors and it has been approved for topical use in the treatment of several dermatologic disorders. Localized hyperpigmentation occurred as a side effect of 5-FU use in cancer treatment attracts the attention toward its application in inducing repigmentation in vitiligo patches.
Latanoprost (LT), a prostaglandin F2 alpha analogue used in the treatment of glaucoma, was found to induce skin pigmentation in guinea pigs in addition to its known periocular and iridal pigmentation side effect.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: