Topical Tranexamic Acid Versus Topical Vitamin C With Microneedling in Periorbital Hyperpigmentation; Comparative Study

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).

Study Overview

• Status: Completed
• Conditions: Periorbital Hyperpigmentation
• Intervention / Treatment: Drug: vitamin c 20%; Drug: Tranexamic acid 5mg/ml

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Doaa Mohsen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• both genders.
• age ≥ 18 years.
• pigmentary, vascular and mixed types of dark halos

Exclusion Criteria:

• pregnancy and lactation
• patients who received treatment in the past 3 months
• patients with active dermatologic diseases or history of atopic dermatitis.
• history of allergy to tranexamic acid or vitamin c
• history of keloid or hypertrophic scars
• pure structural type of dark halos, pigmentary demarcation lines

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group A; one eye was treated with vitamin c 20% + microneedling a session was done every 2 weeks a total of 4 sessions (other eye was placebo treated with saline + microneedling).	Drug: vitamin c 20%; one eye was treated with vitamin c 20% + microneedling a session was done every 2 weeks a total of 4 sessions (other eye was placebo treated with saline + microneedling).; Other Names: vitamin c 20% global cosmetic solutions
Experimental: group B; one eye was treated with tranexamic acid 5 mg/ml + microneedling a session was done every 2 weeks a total of 4 sessions (other eye was placebo treated with saline + microneedling).	Drug: Tranexamic acid 5mg/ml; one eye was treated with tranexamin acid 5 mg/ml + microneedling a session was done every 2 weeks a total of 4 sessions (other eye was placebo treated with saline + microneedling); Other Names: kapron 500mg/ 5ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation	this is evaluated using dermoscopy (giving a score from 0 to 4, 0 = no improvement, 1=1-25% improvement, 2 =26- 50% improvement, 3=51-75% improvement, 4=>75% improvement)	10 weeks (patients are assissed 1 month after the last session)
evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation	clinical improvement by two blinded investigators (giving a score from 0 to 4, 0 = no improvement, 1=1-25% improvement, 2 =26- 50% improvement, 3=51-75% improvement, 4=>75% improvement)	10 weeks (patients are assissed 1 month after the last session)
evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation	clinical improvement by physician (grade from 0 to 4 according to sheth et al.,2014 where 0 no halos and 4 most severe)	10 weeks (patients are assissed 1 month after the last session)
evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation	dermatology life quality index (score from 0 to 30 the higher the worst)	10 weeks (patients are assissed 1 month after the last session)
evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation	patient visual analogue score (score from 0 to 10 the higher the worst)	10 weeks (patients are assissed 1 month after the last session)

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): March 15, 2020
• Study Completion (Actual): March 15, 2020

Study Registration Dates

• First Submitted: December 26, 2020
• First Submitted That Met QC Criteria: January 5, 2021
• First Posted (Actual): January 6, 2021

Study Record Updates

• Last Update Posted (Actual): January 6, 2021
• Last Update Submitted That Met QC Criteria: January 5, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Vitamin C; Microneedling; Tranexamic acid; Periorbital hyperpigmentation
• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hyperpigmentation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Protective Agents; Micronutrients; Antifibrinolytic Agents; Hemostatics; Coagulants; Antioxidants; Tranexamic Acid; Vitamins; Ascorbic Acid
• Other Study ID Numbers: cosmo26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: im looking forward sharing the data but i have no plan yet

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No