Melasma
Conditions
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.
Interventions
DRUGGroup 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
DRUGGroup B Azelaic Acid 20 % Cream for 6 months
Group B was managed with topical 20% azelaic acid (daily at night) for six months.
Sponsors
Combined Military Hospital Abbottabad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Melasma Area and Severity Index | 6 months | Melasma Area and Severity Index Score was used to assess response to treatment.Lowest score=0,Highest Score 48. High score indicates worse outcome. |
Countries
Pakistan
Outcome results
None listed