Tranexamic Acid With Microneedling in Melasma

June 9, 2023 updated by: Norhan Anees, Zagazig University

The Boosting Effect of Hyaluronic Acid on Tranexamic Acid Microneedles in Melasma Patients: A Split- Face Study

Topical tranexamic, a hydrophilic molecule, can't pass the lipid barriers of the stratum corneum and it's also not retained in adequate amount in the epidermis to enter the melanocytes, so there's a difficulty in the effective delivery of tranexamic acid into the melanocytes .

Hyaluronic acid was proved to improve the effective delivery of tranexamic acid through loosening corneocyte packing and helping TXA entering the melanocytes and minimizing its epidermal diffusion .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Melasma is a common acquired pigmentary disorder characterized by irregular symmetric medium- to dark-brown macules and patches affecting the photoexposed areas of the face causing cosmetic disfigurement and low quality of life of the patient. Melsama affects mostly women of reproductive age with Fitzpatrick skin type IV-VI .

The exact pathogenesis of melasma isn't well-known, however the major etiological factors include genetic influences, chronic sun exposure, pregnancy, contraceptives, drugs and hormone therapy. Although the exact pathogenesis of melasma is not fully clarified, the pathophysiology of melasma is believed to involve excess production of melanin or an increase in the activity of melanocytes in the skin .

Melasma is often refractory to treatment with common relapses, so it needs a treatment modality that can be used for long time with minimal side effects. Topical depigmenting agents have good results but also may lead to many side effects.

Microneedling is a minimally invasive technique used for skin rejuvenation and treatment of many diseases, such as dyspigmentation. Gentle microneedling enhances upper dermal changes and increases the epidermal turnover that leads to decreasing melanin production and its deposition in melanocytes and also increasing the epidermal melanin cleareance which improve melasma.

Microneedling enhances transdermal drug delivery across the skin barrier through creating microchannels into the skin without causing actual epidermal damage. Microneedling with topical tranexamic acid (TXA) was proved to be safe, effective and comparatively painless without any detectable side effects.

Tranexamic acid, a hemostatic drug, is used to treat melasma by inhibiting the plasminogen activating system . The intracellular release of arachidonic acid, a precursor to prostaglandins E2, and the level of alpha-melanocyte-stimulating hormone increase as the result of plasmin activity. These two substances can activate melanogenesis. Therefore, the anti-plasmin activity of TA is thought as the main mechanism of hypopigmentory effect of this agent .

Tranexamic acid also inhibits angiogenesis of dermal blood vessels through suppression of vascular endothelial growth factor .

Topical tranexamic, a hydrophilic molecule, can't pass the lipid barriers of the stratum corneum and it's also not retained in adequate amount in the epidermis to enter the melanocytes, so there's a difficulty in the effective delivery of tranexamic acid into the melanocytes .

Hyaluronic acid (HA) was proved to improve the effective delivery of tranexamic acid through loosening corneocyte packing and helping TXA entering the melanocytes and minimizing its epidermal diffusion .

Hyaluronic acid also can actively adhere to melanocytes using cell suface HA receptors (such as cd44), so promotes the targeted delivery to melanocytes .

Study Type

Interventional

Enrollment (Estimated)

27

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged > 18 years.
  • Both sexes.
  • All types of melasma (epidermal, dermal and mixed).
  • Nearly bilateral symmetrical melasma

Exclusion Criteria:

  • Pregnancy and lactation
  • Patients who are taking contraceptive pills at the time of the study or during the past 12 months.
  • Patients with bleeding disorders with hypercoagulable state or the concomitant use of anticoagulants.
  • Patient with history of thrombosis like DVT, coronary artery disease, stroke.
  • Patient using any treatment for melasma during the past 1 month before the study.
  • Active skin infection.
  • Infection and immunosuppression
  • Patient with keloidal tendency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: right side of the face
microneedling with tranexamic acid alone on the right side of the face
Drug: tranexamic acid microneedling
On the left side of face, 0.5 ml of HA 3.5% will be used 1st followed by microneedling then 1 ml of TXA will be applied
Active Comparator: Left side of the face
microneedling with tranexamic acid combined with hyaluronic acid on the left side
Drug: Hyaluronic acid combined with tranexamic acid microneedling
1 ml of TXA, available as a 500 mg/5 ml ampoule, will be applied on the right side of the face after microneedeling and left to dry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Melasma Area Severity Index (mMASI) score
Time Frame: through study completion, an average of 9 months

Hemi-mMASI for each half of the face is calculated according to the following formula:

Hemi-mMASI = 0.15 (A) (D) F + 0.3 (A) (D) M + 0.05 (A) (D) C
through study completion, an average of 9 months
Physician global evaluation
Time Frame: through study completion, an average of 9 months

The improvement of patients is evaluated regarding the improvement in mMASI ( ) and graded as follow:

Poor (improvement < 25%) Fair (improvement 26%-50%) Good (improvement 51%-75%) Excellent (improvement >75%)
through study completion, an average of 9 months
A five-point Likert scale for patient's satisfaction
Time Frame: through study completion, an average of 9 months

Level of patient satisfaction is scored on five points:

  1. Not at all satisfied
  2. Not really satisfied
  3. Undecided
  4. Somewhat satisfied
  5. Very much satisfied
through study completion, an average of 9 months
Pain assessment
Time Frame: through study completion, an average of 9 months
Pain during the session will be assessed and graded as mild, moderate and severe
through study completion, an average of 9 months
Dermoscopic evaluation
Time Frame: through study completion, an average of 9 months

Dermoscopy will be performed for each patient at baseline, during and after each follow-up visit to evaluate the improvement of:

  • Color (light brown, brown, dark brown)
  • Pigmentation (pseudo network and arcuate lesions)
  • Vascularity (present or absent telangiectasia)
through study completion, an average of 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2023

Primary Completion (Estimated)

November 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

February 17, 2023

First Submitted That Met QC Criteria

June 9, 2023

First Posted (Estimated)

June 19, 2023

Study Record Updates

Last Update Posted (Estimated)

June 19, 2023

Last Update Submitted That Met QC Criteria

June 9, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • melasma

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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