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

NCT ID: NCT04697992

Last Updated: 2021-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2020-03-15

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.

Conditions

Periorbital Hyperpigmentation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

group A

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).

Group Type: EXPERIMENTAL

vitamin c 20%

Intervention Type: 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).

group B

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).

Group Type: EXPERIMENTAL

Tranexamic acid 5mg/ml

Intervention Type: 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)

Interventions

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).

Intervention Type: DRUG

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)

Intervention Type: DRUG

Other Intervention Names

vitamin c 20% global cosmetic solutions; kapron 500mg/ 5ml

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

Doaa Mohsen

Doaa Mohsen Fadl Morsy, Principal Investigator, teaching assistant at dermatology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Doaa Mohsen

Giza, , Egypt

Countries

Egypt

Other Identifiers

cosmo26

Identifier Type: -

Identifier Source: org_study_id