Ignite Creation Date:
2025-12-25 @ 3:22 AM
Ignite Modification Date:
2025-12-28 @ 7:50 PM
Study NCT ID:
NCT04599205
Status:
UNKNOWN
Last Update Posted:
2020-10-22
First Post:
2020-09-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Laser and Tranexamic Acid in Treatment of Melasma
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Evaluation of Fractional CO2 Laser and Tranexamic Acid in Treatment of Melasma:Clinical,Histopathological and Immunohistochemical Study
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
NOT_YET_RECRUITING
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:
Melasma Is an acquired, chronic, recurrent, symmetrical hypermelanosis, which is characterized by brown patches of variable darkness on sun exposed areas of the body. It is more common in women. It is common psychologically and emotionally distressing cosmetic problem in affected patients .
Detailed Description:
Many studies examined multiple treatment options for melasma , but none of them is completely satisfactory with recurrence in most cases.
Tranexamic acid is is a relatively new drug for melasma . It is currently used via a spectrum of delivery routes including oral, topical, intradermal, and microneedling .
Laser-assisted drug delivery (LADD) is a technique that facilitates the delivery of topical medications .
On reviewing the previous literatures, few studies have focused on therapeutic effects of combined laser and TXA (topical and intradermal) in melasma, with variations in parameters of laser, in dose, concentration, form and routes of TXA application; and in follow up duration. These studies revealed variable unproven results, and since melasma is a challenging disease, additional studies are needed to determine the optimal laser parameters and the best absorbable topical TXA formula, ensuring the best efficacy and less complications.
To the best of our knowledge, this is the first study that will use topical TXA gel as an additive effect between sessions, and to confirm the effect of laser and TXA by histopathology and immunohistochemistry.
Tranexamic acid is is a relatively new drug for melasma . It is currently used via a spectrum of delivery routes including oral, topical, intradermal, and microneedling .
Laser-assisted drug delivery (LADD) is a technique that facilitates the delivery of topical medications .
On reviewing the previous literatures, few studies have focused on therapeutic effects of combined laser and TXA (topical and intradermal) in melasma, with variations in parameters of laser, in dose, concentration, form and routes of TXA application; and in follow up duration. These studies revealed variable unproven results, and since melasma is a challenging disease, additional studies are needed to determine the optimal laser parameters and the best absorbable topical TXA formula, ensuring the best efficacy and less complications.
To the best of our knowledge, this is the first study that will use topical TXA gel as an additive effect between sessions, and to confirm the effect of laser and TXA by histopathology and immunohistochemistry.
Study Oversight
Has Oversight DMC:
None
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?:
False
Is an FDA AA801 Violation?: