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

Sponsor

Combined Military Hospital Abbottabad (Other)

Overall Status

Completed

CT.gov ID

NCT05887219

Collaborator

(none)

Enrollment

Location

Arms

5.9

Actual Duration (Months)

8.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Melasma	Drug: Group A 4 % Hydroquinone Cream Topically and Oral Tranexamic Acid Drug: Group B Azelaic Acid 20 % Cream for 6 months	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2022

Actual Primary Completion Date :

Apr 30, 2023

Actual Study Completion Date :

Apr 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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)	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
Active Comparator: Group B Azelaic Acid 20 % cream for 6 months 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 Group B was managed with topical 20% azelaic acid (daily at night) for six months.

Arm

Intervention/Treatment

Active Comparator: 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)

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

Active Comparator: Group B Azelaic Acid 20 % cream for 6 months

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

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zahra Nigar	Abbottabad	KPK	Pakistan	22010

Sponsors and Collaborators

Combined Military Hospital Abbottabad

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zahra Nigar, Principal Investigator, Combined Military Hospital Abbottabad

ClinicalTrials.gov Identifier:

NCT05887219

Other Study ID Numbers:

CMHAbbottabad1987

First Posted:

Jun 2, 2023

Last Update Posted:

Jun 2, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 2, 2023