Adverse Effects of Medical Drugs, Effect of Drugs
Conditions
Keywords
Melasma, Tranexamic acid, Mesotherapy
Brief summary
It is a randomized controlled trial in which investigators determine the efficacy of tranexamic acid (TA) by mesotherapy in comparison to normal saline on participants having Melasma.
Detailed description
In this prospective single blind split face controlled trial.Total 30 patients referred to Dermatology Ward were selected. At first, patients were examined under wood lamp for determination of melasma type (epidermal, dermal). Then, patients underwent Tranexamic acid microinjections with a concentration of TA 4 mg/ml with 0.9 % normal saline on their left half of the face and only 0.9%normal saline on their right half of the face, with mesotherapy technique. This procedure was done total of six times with 2-week intervals. Participants were assessed by Hemi Modified Melasma Area and Severity Scoring (mMASI) at start and end of the study for each half of face. Statistical Package for Social Sciences (SPSS) , version 23 was used for analysis. P value \< 0.01 was taken significant.
Interventions
DRUGTranexamic Acid
Tranexamic acid intradermal injections were used for treatment of melasma
DRUG0.9% Normal Saline
Normal saline used for comparision of efficacy of tranexamic acid
Sponsors
Jinnah Postgraduate Medical Centre
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Participant do not know about the split face study. Their one side was injected by tranexamic acid diluted in normal saline while other side was injected with simple normal saline.
Intervention model description
individual patients were selected in study . To control over confounding factors two sides of same patient were used parallel for intradermal injection ( Mesotherapy) of tranexamic acid and with normal saline
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* informed consent * age between 18 to 55 years * bilateral symmetrical mild to severe melasma
Exclusion criteria
* pregnancy and lactation * history of taken any topical treatment for melasma in previous 1 month * history of bleeding disorders * concomitant use of anticoagulants, * any known drug allergy especially to the study drug, * having associated medical illnesses.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HEMI-Modified Melasma Area and Severity Index (mMASI) | 10 months | Calculation of Hemi mMASI score is performed by rating darkness and area of involvement of 3 areas of the each half of face. These figures are then inserted into an equation, resulting in the final Hemi mMASI score for both halves of face. Equation : forehead (0.15×D×A) + malar ( 0.30×D×A) + chin ( 0.05×D×A) The mean value of the data obtained from each half of the face was calculated and the mean percentage change was compared. Hemi-MASI score was used because of the study design of split-face, and it was calculated based on the percentage of the involved area Improvement was considered when there was reduction in mean hemi modified MASI score at both sides of face. Higher score was considered as worse and low score was considered as good in improvement of melasma. At each follow-up visit, adverse events were also evaluated. Patients were asked to reports side effects such as erythema, burning, swelling, and change in menstrual cycle during and after treatment. |
Countries
Pakistan
Outcome results
None listed