Back to resultsComparison of Azelaic Acid 20 % Cream Versus Hydroquinone 4% Cream as an Adjuvant to Oral Tranexamic Acid in Melasma
Primary Purpose
Melasma
Status
Completed
Phase
Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
Group A 4 % Hydroquinone Cream Topically and Oral Tranexamic Acid
Group B Azelaic Acid 20 % Cream for 6 months
Sponsored by
About this trial
This is an interventional treatment trial for Melasma
Eligibility Criteria
Inclusion Criteria: Female patients Aged 20 to 45 years Presented with melasma (symmetrically distributed hyperpigmented macules and patches on the face) Diagnosed by consultant dermatologist on clinical presentation under wood's light. Exclusion Criteria: Pregnant patients Women taking contraceptive pills at the time of study or past 12 months Any chronic illness Allergy to any of the agents used in the treatment Those taking any topical and systemic treatment for melasma in the last one month
Sites / Locations
- Zahra Nigar
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A 4 % Hydroquinone Cream Topically and Oral Tranexamic Acid
Group B Azelaic Acid 20 % cream for 6 months
Arm Description
Group A was managed with 4% hydroquinone cream as an adjuvant to oral tranexamic acid (250 mg twice daily)
group B was managed with topical 20% azelaic acid (daily at night) for six months.
Outcomes
Primary Outcome Measures
Melasma Area and Severity Index
Melasma Area and Severity Index Score was used to assess response to treatment.Lowest score=0,Highest Score 48. High score indicates worse outcome.
Secondary Outcome Measures
Full Information
NCT ID
NCT05887219
First Posted
May 18, 2023
Last Updated
May 31, 2023
Sponsor
Combined Military Hospital Abbottabad
1. Study Identification
Unique Protocol Identification Number
NCT05887219
Brief Title
Comparison of Azelaic Acid 20 % Cream Versus Hydroquinone 4% Cream as an Adjuvant to Oral Tranexamic Acid in Melasma
Official Title
Comparative Efficacy of Azelaic Acid 20% Cream Versus Hydroquinone 4% Cream as an Adjuvant to Oral Tranexamic Acid in Melasma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
April 30, 2023 (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
Methodology: Fifty female patients presented with melasma (symmetrically distributed hyperpigmented macules and patches on the face) diagnosed by consultant dermatologist on clinical presentation were included in this study. The sample size was calculated by WHO Sample Size calculator taking 31% proportion of excellent response with 4% hydroquinone as an adjuvant to oral tranexamic acid as compared to 2.25% proportion of excellent response with 20% azelaic acid, 80% power of test and 5% significance level. After randomization, patients were divided into two groups. Group A was managed with 4% hydroquinone cream as an adjuvant to oral tranexamic acid (250 mg twice daily) while group B was managed with topical 20% azelaic acid (daily at night) for six months. Clinical evaluation was done initially at the start of therapy and then at 2nd, 4th and 6th month using MASI score and patient's response. Efficacy was assessed in both groups at the end of therapy after six months.
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
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A 4 % Hydroquinone Cream Topically and Oral Tranexamic Acid
Arm Type
Active Comparator
Arm Description
Group A was managed with 4% hydroquinone cream as an adjuvant to oral tranexamic acid (250 mg twice daily)
Arm Title
Group B Azelaic Acid 20 % cream for 6 months
Arm Type
Active Comparator
Arm Description
group B was managed with topical 20% azelaic acid (daily at night) for six months.
Intervention Type
Drug
Intervention Name(s)
Group A 4 % Hydroquinone Cream Topically and Oral Tranexamic Acid
Intervention Description
Group A was managed with 4% hydroquinone cream as an adjuvant to oral tranexamic acid (250 mg twice daily) for 6 months
Intervention Type
Drug
Intervention Name(s)
Group B Azelaic Acid 20 % Cream for 6 months
Intervention Description
Group B was managed with topical 20% azelaic acid (daily at night) for six months.
Primary Outcome Measure Information:
Title
Melasma Area and Severity Index
Description
Melasma Area and Severity Index Score was used to assess response to treatment.Lowest score=0,Highest Score 48. High score indicates worse outcome.
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female patients
Aged 20 to 45 years
Presented with melasma (symmetrically distributed hyperpigmented macules and patches on the face)
Diagnosed by consultant dermatologist on clinical presentation under wood's light.
Exclusion Criteria:
Pregnant patients
Women taking contraceptive pills at the time of study or past 12 months
Any chronic illness
Allergy to any of the agents used in the treatment
Those taking any topical and systemic treatment for melasma in the last one month
Facility Information:
Facility Name
Zahra Nigar
City
Abbottabad
State/Province
KPK
ZIP/Postal Code
22010
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Azelaic Acid 20 % Cream Versus Hydroquinone 4% Cream as an Adjuvant to Oral Tranexamic Acid in Melasma
We'll reach out to this number within 24 hrs