Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-26 @ 3:42 AM
Study NCT ID:
NCT04697992
Status:
COMPLETED
Last Update Posted:
2021-01-06
First Post:
2020-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topical Tranexamic Acid Versus Topical Vitamin C With Microneedling in Periorbital Hyperpigmentation; Comparative Study
Sponsor:
Kasr El Aini Hospital
Organization:
Study Overview
Official Title:
Topical Tranexamic Acid Versus Topical Vitamin C With Microneedling in Periorbital Hyperpigmentation; Comparative Study
Status:
COMPLETED
Status Verified Date:
2021-01
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:
Both vitamin C 20% and tranexamic acid 5mg/ml combined with microneedling were used for treatment of periorbital hyperpigmentation in a comparative pattern and both resulted in significant improvement of periorbital hyperpigmentation by dermoscopic and clinical evaluation with no statistically significant difference between them in addition to improvement of patients' visual analogue score (VAS) and dermatology life quality index (DLQI).
Detailed Description:
Sixty patients with periorbital hyperpigmentation were enrolled, patients were divided into 2 groups; 30 each. clinical grading according to sheth et al.,2014 , dermoscopic evaluation, visual analogue score (VAS) and DLQI were done at week 0. Group A one side was treated with vit.c 20% + microneedling, other side saline+ microneedling (placebo). group B one side was treated with tranexamic acid 5mg/ml + microneedling, other side saline+ microneedling (placebo). A total of 4 sessions were done 2 weeks apart and follow up was one month after the last session (week 10) at which patient was evaluated using above mentioned parameters in addition to evaluation by 2 blinded investigators. At week 10 there was significant improvement of clinical grading and as evaluated by blinded investigators, VAS, DLQI, significant dermoscopic improvement in both vascular and pigmentary components of dark halos in sides treated with vit c and tranexamic acid compared to placebo but there was no statistically significant difference between both groups. The study concluded that tranexamic acid is a new safe effective modality in treatment of periorbital hyperpigmentation with results comparable to vitamin C.
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?: