Clinical trial

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

ID

Name

melasma

Description

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 .

Trial arms

Trial start

2023-06-01

Estimated PCD

2023-11-01

Trial end

2023-12-01

Status

Not yet recruiting

Phase

Early phase I

Treatment

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

Arms:

Left side of the face

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

Arms:

right side of the face

Size

27

Primary endpoint

Modified Melasma Area Severity Index (mMASI) score

through study completion, an average of 9 months

Physician global evaluation

through study completion, an average of 9 months

A five-point Likert scale for patient's satisfaction

through study completion, an average of 9 months

Pain assessment

through study completion, an average of 9 months

Dermoscopic evaluation

through study completion, an average of 9 months

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 27, 'type': 'ESTIMATED'}}

Updated at

2023-06-18

1 organization

2 products

1 indication

Organization

Zagazig University

Product

Hyaluronic acid + Tranexamic acid microneedling

Indication

Product

Tranexamic acid