Comparison of Chemical Peeling Agent With Transamine for Treatment of Melasma
Primary Purpose
Melasma
Status
Completed
Phase
Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
Glycolic Acid 70%
Tranexamic acid injection
Sponsored by
About this trial
This is an interventional treatment trial for Melasma
Eligibility Criteria
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
Sites / Locations
- Combined military hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A 70% Glycolic acid
Group B intradermal tranexamic acid
Arm Description
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
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05362500
First Posted
April 21, 2022
Last Updated
April 30, 2022
Sponsor
Combined Military Hospital Abbottabad
1. Study Identification
Unique Protocol Identification Number
NCT05362500
Brief Title
Comparison of Chemical Peeling Agent With Transamine for Treatment of Melasma
Official Title
Comparative Study Between Chemical Peeling With 70% Glycolic Acid and Intradermal Transamine for the Treatment of Melasma.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Combined Military Hospital Abbottabad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melasma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A 70% Glycolic acid
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group B intradermal tranexamic acid
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Glycolic Acid 70%
Other Intervention Name(s)
Peeling agent
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid injection
Other Intervention Name(s)
transamine injection
Intervention Description
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
Primary Outcome Measure Information:
Title
Effectiveness of 70%glycolic acid and intradermal transamine for treatment of melasma as assessed by MODIFIED MELASMA SEVERITY INDEX (mMASI)
Description
Modified melasma severity index was used to measure effectiveness of both drugs.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naheed Khan
Organizational Affiliation
Cpsp
Official's Role
Principal Investigator
Facility Information:
Facility Name
Combined military hospital
City
Abbottābād
State/Province
Kpk
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Chemical Peeling Agent With Transamine for Treatment of Melasma
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