Periorbital Hyperpigmentation
Conditions
Keywords
Periorbital hyperpigmentation, Vitamin C, Tranexamic acid, Microneedling
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.
Interventions
DRUGvitamin 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).
DRUGTranexamic 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)
Sponsors
Kasr El Aini Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
blinded investigators that assess grade of improvement at end of the study compared to baseline
Intervention model description
clinical trial, patients were divided into two groups, 30 each.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| evaluation of effectiveness of tranexamic acid in periorbital hyperpigmentation | 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) |
Countries
Egypt
Outcome results
None listed