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

NCT05887219 | Completed Phase 1

• 1 other identifier: CMHAbbottabad1987
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Melasma

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Study Arms (2)

Group A 4 % Hydroquinone Cream Topically and Oral Tranexamic Acid

ACTIVE COMPARATOR

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

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

Group B Azelaic Acid 20 % cream for 6 months

ACTIVE COMPARATOR

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

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

Interventions

Group A 4 % Hydroquinone Cream Topically and Oral Tranexamic Acid DRUG

Group A was managed with 4% hydroquinone cream as an adjuvant to oral tranexamic acid (250 mg twice daily) for 6 months

Group A 4 % Hydroquinone Cream Topically and Oral Tranexamic Acid

Group B Azelaic Acid 20 % Cream for 6 months DRUG

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

Group B Azelaic Acid 20 % cream for 6 months

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Combined Military Hospital Abbottabad: lead

Study Sites (1)

Zahra Nigar

Abbottabad, KPK, 22010, Pakistan

Location

MeSH Terms

Conditions

Melanosis

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: June 2, 2023
• Study Start: November 1, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: June 2, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)