A Study to Compare Azelaic Acid Cream Alone with Azelaic Acid and Tranexamic Acid Creams for Treating Hyperpigmented Patches

The requested reference [4d9455c721fd9cb6486327aec4786cc3c3892a15] no longer exists in our database. It has been replaced by the current reference: [859c1b7af05780fbed261081ba652f21be95df54]

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2026
INTERVENTION: Intervention1: Topical Azelaic Acid: Topical Azelaic Acid 20 percent cream applied over the affected area once daily in the evening for 12 weeks Control Intervention1: Topical Azelaic acid and Topical Tranexamic acid: Topical Tranexamic acid 5 percent gel once daily in the morning over affected area and Topical Azelaic acid 20 percent cream in the evening once daily over affected area for 12 weeks CONDITION: Health Condition 1: L811‐ Chloasma PRIMARY OUTCOME: efficacy parameters ; Change in the score of melasma area severity index MASI from baseline to week 12Timepoint: efficacy parameters ; Change in the score of melasma area severity index MASI from baseline to week 12 SECONDARY OUTCOME: Safety parameter ; Incidence and severity of adverse events if any in both study groupsTimepoint: baseline 8 weeks and 12 weeks INCLUSION CRITERIA: Participants of either gender aged 18 to 60 years with a clinical diagnosis of epidermal or mixed type facial melasma confirmed by dermatological examination. Willingness to avoid excessive sun exposure tanning procedures and use of non study topical cosmetic or lightening products during the study period. Willingness to use a standardized sunscreen SPF greater or equal to 30 and comply with study instructions throughout the study duration. Participants capable of understanding the study procedures and willing to provide written informed consent. Women of childbearing potential willing to use acceptable contraception during the study period if applicable. Participants willing and able to attend all scheduled visits and comply with study procedures.
Epistemonikos ID: 46de0d93b168afe3186c0aecba7c0661244778ed
First added on: Oct 08, 2026