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

Primary Purpose

Periorbital Hyperpigmentation

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
vitamin c 20%
Tranexamic acid 5mg/ml
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periorbital Hyperpigmentation focused on measuring Periorbital hyperpigmentation, Vitamin C, Tranexamic acid, Microneedling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Doaa Mohsen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

group A

group B

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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)
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)
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)
evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation
dermatology life quality index (score from 0 to 30 the higher the worst)
evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation
patient visual analogue score (score from 0 to 10 the higher the worst)

Secondary Outcome Measures

Full Information

First Posted
December 26, 2020
Last Updated
January 5, 2021
Sponsor
Kasr El Aini Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04697992
Brief Title
Topical Tranexamic Acid Versus Topical Vitamin C With Microneedling in Periorbital Hyperpigmentation; Comparative Study
Official Title
Topical Tranexamic Acid Versus Topical Vitamin C With Microneedling in Periorbital Hyperpigmentation; Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
March 15, 2020 (Actual)
Study Completion Date
March 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periorbital Hyperpigmentation
Keywords
Periorbital hyperpigmentation, Vitamin C, Tranexamic acid, Microneedling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
clinical trial, patients were divided into two groups, 30 each.
Masking
Outcomes Assessor
Masking Description
blinded investigators that assess grade of improvement at end of the study compared to baseline
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Experimental
Arm Description
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).
Arm Title
group B
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
vitamin c 20%
Other Intervention Name(s)
vitamin c 20% global cosmetic solutions
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid 5mg/ml
Other Intervention Name(s)
kapron 500mg/ 5ml
Intervention Description
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)
Primary Outcome Measure Information:
Title
evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation
Description
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)
Time Frame
10 weeks (patients are assissed 1 month after the last session)
Title
evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation
Description
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)
Time Frame
10 weeks (patients are assissed 1 month after the last session)
Title
evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation
Description
clinical improvement by physician (grade from 0 to 4 according to sheth et al.,2014 where 0 no halos and 4 most severe)
Time Frame
10 weeks (patients are assissed 1 month after the last session)
Title
evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation
Description
dermatology life quality index (score from 0 to 30 the higher the worst)
Time Frame
10 weeks (patients are assissed 1 month after the last session)
Title
evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation
Description
patient visual analogue score (score from 0 to 10 the higher the worst)
Time Frame
10 weeks (patients are assissed 1 month after the last session)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Doaa Mohsen
City
Giza
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
im looking forward sharing the data but i have no plan yet

Learn more about this trial

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

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