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

Periorbital Hyperpigmentation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04697992
• Other study ID #: cosmo26
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: March 15, 2020

Study information

• Verified date: January 2021
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperpigmentation
• Periorbital Hyperpigmentation

Intervention

Drug:
• vitamin 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).
• Tranexamic acid 5mg/ml
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)

Locations

Country	Name	City	State
Egypt	Doaa Mohsen	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)