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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05887219
Other study ID # CMHAbbottabad1987
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date November 1, 2022
Est. completion date April 30, 2023

Study information

Verified date May 2023
Source Combined Military Hospital Abbottabad
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date April 30, 2023
Est. primary completion date April 30, 2023
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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
Group B Azelaic Acid 20 % Cream for 6 months
Group B was managed with topical 20% azelaic acid (daily at night) for six months.

Locations

Country Name City State
Pakistan Zahra Nigar Abbottabad KPK

Sponsors (1)

Lead Sponsor Collaborator
Combined Military Hospital Abbottabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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