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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Periorbital Hyperpigmentation

Intervention / Treatment
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* Drug: vitamin c 20%
* Drug: Tranexamic acid 5mg/ml


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: clinical trial, patients were divided into two groups, 30 each.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group A<br>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%<br>* 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).<br>* Other names: vitamin c 20% global cosmetic solutions;|
| Experimental: group B<br>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<br>* 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)<br>* Other names: kapron 500mg/ 5ml;|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periorbital hyperpigmentation, Vitamin C, Tranexamic acid, Microneedling