Randomized trial demonstrates tomato extract cream reduces hyperpigmentation as effectively as Kligman’s formula in melasma patients, suggesting a safe, well-tolerated alternative.
Background: Melasma is a common pigmentary disorder, for which Kligman’s Formula is a standard topical therapy, though adverse effects limit prolonged use. Cosmeceutical alternatives with antioxidant properties may present potential benefits for long-term management. Aims: To compare the efficacy of a cosmeceutical cream containing Solanum lycopersicum (tomato) extract with Kligman’s Formula in the treatment of facial melasma. Methods: In this single-blind, split-face, pilot randomized controlled trial, patients with melasma received either Kligman’s Formula or the tomato extract-based cosmeceutical cream for 56 days. Main outcomes were changes in modified Melasma Area and Severity Index (mMASI) and Melasma Severity Scale (MSS) scores. Safety was assessed based on the incidence of adverse events. Results: Both creams significantly reduced mMASI scores after 56 days (Kligman’s Formula: −1.394, p < 0.001; cosmeceutical cream: −1.471, p < 0.001), suggestive of comparable efficacy, as this pilot study was not formally powered for non-inferiority testing, this finding should be interpreted as hypothesis-generating. MSS scores were not statistically analyzed due to the ordinal, small-range nature of the data. The proportion of patients with moderate to severe melasma (MSS ≥ 2) decreased by day 56 for both treatments. At day 56, patient-rated MSS scores ≥ 2 declined from 100% to 59.3% with Kligman’s Formula and from 96.3% to 66.7% with the cosmeceutical cream. Reported adverse events were mild and self-limiting in both groups. Conclusions: Preliminary findings suggest the cosmeceutical cream containing Solanum lycopersicum is comparable to Kligman’s Formula in improving melasma severity. Its antioxidant-rich, well-tolerated profile in this short-term pilot warrants further investigation as a potential safe option for long-term or adjunctive therapy in melasma.
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Kei et al. (2026) studied this question.
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