Comparison of Chemical Peeling Agent With Transamine for Treatment of Melasma

NCT05362500 | Completed Phase 1

• 2 other identifiers: CMHatd-ETH-22-derm-22131/CPSP
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Melasma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group A 70% Glycolic acid

ACTIVE COMPARATOR

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

Drug: Glycolic Acid 70%

Group B intradermal tranexamic acid

ACTIVE COMPARATOR

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

Drug: Tranexamic acid injection

Interventions

Glycolic Acid 70% DRUG

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

Also known as: Peeling agent

Group A 70% Glycolic acid

Tranexamic acid injection DRUG

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

Also known as: transamine injection

Group B intradermal tranexamic acid

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients suffering from Melasma who attended the Dermatology department

You may not qualify if:

• 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

Sponsors & Collaborators

• Combined Military Hospital Abbottabad: lead

Study Sites (1)

Combined military hospital

Abbottābād, Kpk, Pakistan

Location

MeSH Terms

Conditions

Melanosis

Interventions

Tranexamic Acid; Tranylcypromine

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Propylamines; Amines

Study Officials

• Naheed Khan

  Cpsp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: May 5, 2022
• Study Start: June 1, 2021
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: May 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)