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Objective: To observe the efficacy and safety of Lishi Oral Liquid (LOL), a Chinese herbs formula, combined with levocetirizine, an antihistamine drug, in patients with damp-heat atopic dermatitis (AD).

Methods: A randomized double-blind placebo-controlled clinical trial was conducted. Ninety patients diagnosed with damp-heat atopic dermatitis were randomly assigned to Lishi Oral Liquid group and control group at the ratio of 1:1. Patients were given one Lishi Oral Liquid or placebo three times per day. Both groups were treated with allantoin and vitamin E cream by topical use and levocetirizine by oral administration. Patients were followed up at the second and fourth week. The primary outcome was the scoring of atopic dermatitis (SCORAD). The secondary outcomes were visual analogue scale (VAS) and dermatology life quality index (DLQI).

Results: After two weeks of treatment, there were statistical differences in SCORAD between these two groups ($P<0.05$), whereas VAS and DLQI showed no statistical differences. There were significant differences in SCORAD and VAS between two groups at the end of four weeks of treatment ($P<0.05$). However, no significant differences were observed in DLQI after four weeks of treatment. No serious adverse event was found during this clinical trial.

Conclusion: LOL combined with levocetirizine is effective and safe for damp-heat AD treatment.