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Completed

NCT Number: NCT04697992

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).

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Key information

Conditions

Periorbital Hyperpigmentation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Doaa Mohsen

Giza, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vitamin c 20%

Drug

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

Tranexamic acid 5mg/ml

Drug

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

Primary outcomes

  1. evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation

    Time frame: 10 weeks (patients are assissed 1 month after the last session)

    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)

  2. evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation

    Time frame: 10 weeks (patients are assissed 1 month after the last session)

    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)

  3. evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation

    Time frame: 10 weeks (patients are assissed 1 month after the last session)

    clinical improvement by physician (grade from 0 to 4 according to sheth et al.,2014 where 0 no halos and 4 most severe)

  4. evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation

    Time frame: 10 weeks (patients are assissed 1 month after the last session)

    dermatology life quality index (score from 0 to 30 the higher the worst)

  5. evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation

    Time frame: 10 weeks (patients are assissed 1 month after the last session)

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

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 6, 2021
Registry last updated
Jan 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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