We found no systematic reviews. One RCT done in the US (52 people: 45 non-pregnant or non-nursing women, 7 men; skin phototype IV, V or VI; clinical diagnosis of facial hyperpigmentation which could in some cases be caused by melasma) compared azelaic acid with placebo.23 After 24 weeks the authors found a statistically significant decrease in the treatment group in pigmentary intensity as measured by chromometer analysis (P= 0-039) and investigators' subjective scale (P= 0-021). The study failed to differentiate at any stage those participants with melasma from those with other hyperpigmentation disorders, making it difficult to draw conclusions applicable to people with melasma.
We found one RCT and one non-randomised controlled trial comparing azelaic acid with hydroquinone. The RCT24 was in 340 people with non-dermal melasma (17 men evenly distributed), and compared twice-daily 20% azelaic acid cream with twice-daily 2% hydroquinone cream for 24 weeks. It found that improvement (defined as a reduction of >50% in a score including area and pigmentation) was higher with azelaic acid (106/154 (69%) than with hydroquinone (88/161 (55%)); RR 1-26; CI 1-06-1-50; NNT 7, CI 4-30). The majority of patients were of skin phototypes III-VI. No subgroup analysis was done to determine if men had a different response to women. The non-randomised controlled trial25 (60 women with skin phototypes I-IV, centromalar or facial distribution, followed for 24 weeks) included women with epidermal (72%) or mixed melasma (28%), in the age range 18-40 years. Thirty per cent of women were taking oral contraceptives. The trial compared 20% azelaic acid cream with 4% hydroquinone cream. All women were given sunscreen (details not provided) and were asked to apply azelaic acid on one side of their face and hydroquinone in the other side, twice daily for 24 weeks. No detail is provided to explain how interventions were concealed. Improvement was assessed subjectively by participants and evaluators. The study was completed by 85% of participants. Improvement was similar in women receiving azelaic acid (23/26 (88%) and hydroquinone (22/25 (88%); RR 1-0, CI 0-8-1-3).
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