Abstract

Goal. To assess the efficacy and safety of Azelic (15% gel of azelaic acid for topical administration) for the treatment of chloasma in pregnant women. Materials and methods. The study involved 28 pregnant women aged 18-36 (mean age: 24.7) with a normal course of pregnancy. The patients consulted a doctor in the spring, summer or fall complaining of focal skin hyperpigmentation on the face, chin and chest area. Ten patients (35.7%) developed hyperpigmentation prior to their pregnancy and 18 women (64.3%) - during the pregnancy. As of the consultation date, the pregnancy terms in all of the patients were 18-20 weeks. Chloasma was diagnosed by using dermatoscopy and skin examination with the Wood’s lamp. The patients were informed about the content and procedure of the study and gave their consent to take part in the study. Thin layers of Azelic (15% gel of azelaic acid for topical administration) were applied to the hyperpigmented skin of the patients and gently rubbed twice a day (in the morning and evening) as topical treatment for four months. The treatment results were assessed taking into consideration the patient’s subjective assessment, study group structure depending on the clinical efficacy, percentage of adverse events, and survey results based on the Dermatology Life Quality Index questionnaire. To reveal any potential general toxicological effects of the treatment, hepatic samples, total blood count and coagulogram results were analyzed as a part of obstetrical and gynecologic care for pregnant women. Key findings. Positive dynamics of the following characteristics was revealed: subjective assessment of treatment results by the patients, clinical efficacy of treatment and life quality index. Therapeutic results were observed as early as after one month but not later than three months after the treatment began. The therapeutic efficacy was recorded in 92.9-96.4% of all cases after four months of treatment: pigment spots disappeared or became paler, and their dimensions and their contrast as compared to the healthy skin reduced, the skin texture and life quality improved (the Dermatology Life Quality Index reduced from 15.5 ± 1.8 to 6.7 ± 0.5 points against the background of the treatment efficacy: from severe to moderate impact of the disease on the patient’s life, respectively). Five women (17.9%) developed erythema and burning sensations in the drug application site within the first two weeks immediately after the gel application (one of the patients had the same symptoms for six weeks of the treatment); the symptoms were weak and transient and did not require any additional treatment. Hepatic samples, total blood count and coagulogram results were within physiological standards during the treatment. Conclusion. Topical application of Azelic (15% gel of azelaic acid for topical administration) twice a day for four months is an efficient and safe method to treat chloasma in pregnant women.

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