Clinical trial NCT04697992: 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
Overall status: COMPLETED
Phase: NA
Conditions: Periorbital Hyperpigmentation
Keywords: Periorbital hyperpigmentation
Vitamin C
Tranexamic acid
Microneedling
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: clinical trial, patients were divided into two groups, 30 each.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation
timeFrame: 10 weeks (patients are assissed 1 month after the last session)
measure: evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation
timeFrame: 10 weeks (patients are assissed 1 month after the last session)
measure: evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation
timeFrame: 10 weeks (patients are assissed 1 month after the last session)
measure: evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation
timeFrame: 10 weeks (patients are assissed 1 month after the last session)
measure: evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation
timeFrame: 10 weeks (patients are assissed 1 month after the last session)
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Doaa Mohsen
Study officials:
References: