Comparative efficacy of topical tranexamic acid with different depths of microneedling in melasma

AIMS AND OBJECTIVES-

1.     To compare the clinical efficacy of 0.75mm v/s 1.5mm microneedling depth with 10 % topical tranexamic acid in melasma.

2.     To compare the adverse effects of 0.75mm v/s 1.5mm microneedling depth with 10% topical tranexamic acid in melasma.

MATERIALS AND METHODS

STUDY DESIGN: Split face, prospective clinical trial.

STUDY SETTING: Department of Dermatology, Venereology and Leprosy, Government Medical College and Hospital, Sector 32, Chandigarh.

SAMPLE SIZE- Sample size is calculated on the basis of 65.92% response rate for 1.5mm microneedling side of face and hypothetical response rate of 30% for 0.75mm microneedling half of face.14 For 90% power of the test and 5% level of significance, sample size comes out be around 32. Accordingly taking in account the possibility of irregular or loss to follow up patients, 40 patients will be recruited in the study receiving topical tranexamic acid 10% along with microneedling with 0.75 mm depth on one side and 1.5mm on the other side of their face.

INCLUSION CRITERIA:

1. Patients of 18-50 years of age with clinical diagnosis of facial melasma.

EXCLUSION CRITERIA:

1. Patients with known bleeding diathesis.

2. Patient taking anticoagulants, estrogen, progesterone, and antiandrogens.

3. Pregnant and lactating mothers.

4. Patients with any systemic illness.

METHOD:

Clinical evaluation will comprise of ascertaining the skin type and the type of melasma.

The patients will be assessed for the type of melasma as centro-facial / malar / mandibular / mixed depending upon their distribution on the face. Woods light examination will be done to assess the depth of melasma as epidermal/dermal/mixed. Melasma will be assessed before starting the treatment by using the hemi-mMASI.24 By this method, the severity of melasma in the patient is assessed by examining each of the three regions (half forehead, right/left malar region and half of chin) and this scoring system is based on two parameters, that are percentage of the total area involved (A) and darkness (D). Numerical value is assigned to area and darkness and total hemi-mMASI score is calculated by the given formula: mMASI score = Forehead 0.15 DA + Right/Left malar 0.3DA+ Chin 0.05DA. The hemi-mMASI scoring ranges from 0 to 12. Baseline laboratory investigations like CBC and coagulation profile shall be done for all the patients.

PROCEDURE:

Forty patients will be recruited, each will receive tranexamic acid 10% topical solution on both sides of face with one half receiving microneedling depth of 0.75mm and other half receiving 1.5mm. The randomisation of side receiving 0.75mm or 1.5mm will be done by random table method. Each patient will receive 4 sessions at 2 weekly intervals (0, 2, 4 and 6) and patient shall be followed up at 4 weeks after the last session. Prior to each session, the face will be cleaned with a gauze soaked in 70% isopropyl alcohol. Topical local anaesthetic cream, eutectic mixture of 2.5% lidocaine and 2.5% prilocaine will be applied under an occlusive dressing and kept there for an hour before the procedure. Topical tranexamic acid solution 10% will be applied on each side of face prior to microneedling. The skin will then be stretched with the nondominant hand and microneedling will be carried out using a dermaroller of needle depth 0.75mm over one side of face and 1.5mm over the other half in vertical, horizontal, and both diagonal directions for about four to five times. 10% topical tranexamic acid will be applied on each side of the face after microneedling and left to dry.

Following treatment, they will be advised strict photoprotection by avoidance of sun exposure and physical protection whenever outdoors. They will be strictly cautioned against the use of any unprescribed topical agent, fairness cream, or any facial cosmetic procedure which may interfere with the therapeutic outcome. Assessment of improvement for efficacy of therapy will be done by calculating the hemi-mMASI of the face at each visit (0, 2, 4 and 6 weeks) and 4 weeks later for follow up.

Hemi-mMASI score will be calculated for each half of the face before each session to determine the severity of melasma. Hemi-mMASI is calculated by the percentage of involved area and darkness in patches of melasma. Hemi-mMASI = forehead (0.15×D×A) + malar (0.30×D×A) + chin (0.05×D×A)

A =Area graded from 0-6 as 0=0%, 1=1%-9%, 2=10%-29%, 3=30%-49%, 4=50%-69%, 5=70%-89%, 6=90%-100%

D= Darkness of patches graded from 0-4 0=absent or normal skin color without evidence of hyperpigmentation, 1=slight visible hyperpigmentation, 2=mild visible, 3=marked, 4=severe

At the end of this study, means of Hemi-mMasi score from right and left side of face will be calculated separately and the mean of difference between both groups will be compared. The response of patients towards improvement will be graded as per their level of self-satisfaction at the end of study as:

1.      Poor response rate= 0-25% reduction

2.      Fair response rate= 25-50% reduction

3.      Good response rate=50-75% reduction

4.      Excellent response rate=75-100% reduction24

Clinical photographs will be taken and labelled by specific numbers for each patient before starting the treatment and at each follow up visit. To assess for adverse effects, patients will be provided with a check list of possible side effects at every visit.