Comparison of Chemical Peeling Agent With Transamine for Treatment of Melasma
Condition: Melasma
MeSH terms: Melanosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Melasma is an acquired skin disorder characterized by hyper-melanosis. Melasma is a term that
      originates from the Greek root "melas" (black color) and was formerly known as chloasma.
      Melasma is more common in sun-exposed tissues such as the cheeks, chin, upper lip, and
      forehead. Melasma is a common dermatological disorder with a frequency of 8.8 percent in the
      United States, but it can be as high as 40 percent amongst females. Melasma affects mostly
      ladies and is most common throughout their reproductive years .

      Melasma causes an increase in melanin pigment synthesis owing to a surge in the number of
      melanosomes, which are membrane-bound cell organelles inside melanocytes where melanin
      biosynthesis occurs and is transported to keratinocytes. Except in rare situations, the
      number of melanocytes will not be enhanced. Melanocytes will grow in size, and dendrites will
      become more visible. Despite the fact that the specific causation is unknown, some elements
      are thought to have a role in the pathophysiological mechanisms of melasma). Among these, sun
      exposure (UV light) is the most powerful primary trigger for its growth, which explains
      melisma's propensity for certain areas of the body. Other major determinants include genetic
      predisposition, and female hormones - both endogenous (that is, during pregnancy) and
      exogenous (that is, during pregnancy) (contraceptives and hormone replacement therapy).
      Thyroid problems, medications, and cosmetics can all be aggravating factors. Evaluation and
      prevention of triggering variables are essential in order to avoid recurrence .

      The peeling effect of glycolic acid is due to chemo exfoliation capabilities, that rely upon
      aiding the elimination of keratinocytes, resulting in melanin reduction and speeding up the
      regeneration of skin. TA suppresses UV-stimulated plasmin action in keratin cells by blocking
      plasminogen appending to the keratin cells, resulting from lower free arachidonic acid levels
      or to reduced capacity of prostaglandins production, which reduces melanocyte tyrosinase
      activity .

      The study's implications are to analyze the efficacy of these two drugs in order to assess
      the better outcome of patients with evidence-based management.
    

Detailed description: 
      A randomized controlled trial study (single-blind) was done In the Dermatology Unit of the
      CMH, Abbottabad from June to November 2021 after Ethical Review Board approval, the 54
      patients aged 20-50 years after informed consent were enrolled using a technique of
      non-probability consecutive sampling. The sample size was determined using the WHO sample
      size calculator, With a significance level of 95%, power of study 80%, the ratio of sample
      size B: A of 1 and Assumed MASI score in Group A (Tranexamic Acid) Mean + SD = 9.37 ± 2.18,
      in Group B (Glycolic Acid 70%) Mean + SD = 10.25 ± 2.93. Thus, the required sample size was
      54 (27 in each group).

      For randomization, the final recruited 54 participants (38 females, 16 males; aged 20-50
      years), recruited into two groups i.e. Group A: contain 27 patients which had been treated
      every 2 weeks for 12 weeks with 70% glycolic acid to assess chemical peeling and cold water
      was used for washing to stop peeling as displayed and Group B: contain 27 patients treated
      with an intradermal injection of 0.05 mL of tranexamic acid solution in normal saline (4
      mg/mL) into the melasma lesion at 1 cm distance using a sterile insulin syringe, weekly for
      12 weeks .
    

Intervention name(s): Glycolic Acid 70%; Tranexamic acid injection
Intervention type(s): Drug; Drug
Intervention description(s): Group A: contain 27 patients which had been treated every 2 weeks for 12 weeks with 70% glycolic acid to assess chemical peeling and cold water was used for washing; Group B: contain 27 patients treated with an intradermal injection of 0.05 mL of tranexamic acid solution in normal saline (4 mg/mL) into the melasma lesion at 1 cm distance using a sterile insulin syringe, weekly for 12 weeks
Other intervention name(s): Peeling agent; transamine injection
Intervention MeSH terms: Tranylcypromine; Glycolic acid; Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment