Comparison of Azelaic Acid 20 % Cream Versus Hydroquinone 4% Cream as an Adjuvant to Oral Tranexamic Acid in Melasma

Combined Military Hospital Abbottabad

Status and phase: Completed; Phase 1

Conditions: Melasma

Treatments: Drug: Group B Azelaic Acid 20 % Cream for 6 months; Drug: Group A 4 % Hydroquinone Cream Topically and Oral Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT05887219

CMHAbbottabad1987

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

Group A 4 % Hydroquinone Cream Topically and Oral Tranexamic Acid

Active Comparator group

Description:

Group A was managed with 4% hydroquinone cream as an adjuvant to oral tranexamic acid (250 mg twice daily)

Treatment:

Drug: Group A 4 % Hydroquinone Cream Topically and Oral Tranexamic Acid

Group B Azelaic Acid 20 % cream for 6 months

Active Comparator group

Description:

group B was managed with topical 20% azelaic acid (daily at night) for six months.

Treatment:

Drug: Group B Azelaic Acid 20 % Cream for 6 months