Trials / Completed
CompletedNCT05887219
Comparison of Azelaic Acid 20 % Cream Versus Hydroquinone 4% Cream as an Adjuvant to Oral Tranexamic Acid in Melasma
Comparative Efficacy of Azelaic Acid 20% Cream Versus Hydroquinone 4% Cream as an Adjuvant to Oral Tranexamic Acid in Melasma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Combined Military Hospital Abbottabad · Academic / Other
- Sex
- Female
- Age
- 20 Years – 45 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Group A 4 % Hydroquinone Cream Topically and Oral Tranexamic Acid | Group A was managed with 4% hydroquinone cream as an adjuvant to oral tranexamic acid (250 mg twice daily) for 6 months |
| DRUG | Group B Azelaic Acid 20 % Cream for 6 months | Group B was managed with topical 20% azelaic acid (daily at night) for six months. |
Timeline
- Start date
- 2022-11-01
- Primary completion
- 2023-04-30
- Completion
- 2023-04-30
- First posted
- 2023-06-02
- Last updated
- 2023-06-02
Locations
1 site across 1 country: Pakistan
Source: ClinicalTrials.gov record NCT05887219. Inclusion in this directory is not an endorsement.