Comparison of Chemical Peeling Agent With Transamine for Treatment of Melasma

Melasma Clinical Trial

Official title:

Comparative Study Between Chemical Peeling With 70% Glycolic Acid and Intradermal Transamine for the Treatment of Melasma.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05362500
• Other study ID #: CMHatd-ETH-22-derm-22
• Secondary ID: 131/CPSP
• Status: Completed
• Phase: Phase 1
• Start date: June 1, 2021
• Est. completion date: November 30, 2021

Study information

• Verified date: April 2022
• Source: Combined Military Hospital Abbottabad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• patients suffering from Melasma who attended the Dermatology department

Exclusion Criteria:

• history of hormone therapy and contraceptive pills (within the previous 12 months)

• bleeding problems or concurrent use of anticoagulants

• Topical treatment such as hydroquinone (one month prior to the research)

• Active herpes simplex, face warts or active dermatoses

• History of hypersensitivity to some of the study's components

• Pregnant or lactating females

• Patients with unrealistic expectations

Related Conditions & MeSH terms

• Melanosis
• Melasma

Intervention

Drug:
• Glycolic Acid 70%
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
• Tranexamic acid injection
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

Locations

Country	Name	City	State
Pakistan	Combined military hospital	Abbottabad	Kpk

Sponsors (1)

Lead Sponsor	Collaborator
Combined Military Hospital Abbottabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of 70%glycolic acid and intradermal transamine for treatment of melasma as assessed by MODIFIED MELASMA SEVERITY INDEX (mMASI)	Modified melasma severity index was used to measure effectiveness of both drugs.	12 weeks