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

NCT04697992 | Completed

• 1 other identifier: cosmo26
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Periorbital Hyperpigmentation

Keywords

Periorbital hyperpigmentation; Vitamin C; Tranexamic acid; Microneedling

Outcome Measures

Primary Outcomes (5)

• 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)

Study Arms (2)

group A

EXPERIMENTAL

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%

group B

EXPERIMENTAL

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

Interventions

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).

Also known as: vitamin c 20% global cosmetic solutions

group A

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)

Also known as: kapron 500mg/ 5ml

group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Doaa Mohsen

Giza, Egypt

Location

MeSH Terms

Interventions

Ascorbic Acid; Tranexamic Acid

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Cyclohexanecarboxylic Acids; Acids, Carbocyclic

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: blinded investigators that assess grade of improvement at end of the study compared to baseline
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doaa Mohsen Fadl Morsy, Principal Investigator, teaching assistant at dermatology department

Model Details: clinical trial, patients were divided into two groups, 30 each.

Study Record Dates

• First Submitted: December 26, 2020
• First Posted: January 6, 2021
• Study Start: November 1, 2019
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: January 6, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)