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

Not Applicable
Completed
Conditions
Periorbital Hyperpigmentation
Interventions
Drug: Tranexamic acid 5mg/ml
Drug: vitamin c 20%
Registration Number
NCT04697992
Lead Sponsor
Kasr El Aini Hospital
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
group BTranexamic acid 5mg/mlone 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).
group Avitamin 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).
Primary Outcome Measures
NameTimeMethod
evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation10 weeks (patients are assissed 1 month after the last session)

patient visual analogue score (score from 0 to 10 the higher the worst)

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Doaa Mohsen

🇪🇬

Giza, Egypt

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