Abstract: OBJECTIVE To explore the influences of Qingre Chushi Jiedu Formula on skin physiological indexes and immune indexes in patients with acne due to damp-heat in spleen and stomach. METHODS 102 cases with acne caused by dampness-heat in the spleen and stomach hospitalized in our hospital from June， 2015 to September， 2016 were chosen and randomly divided into the observation group and control group based on random number method， with 51 cases in each group. Patients in the control group were given Danshentong Capsule， while those in the observation group were treated with Qingre Chushi Jiedu Formula. The treatment lasted for four weeks in total. Then the improvement of clinical symptoms were observed， with skin physiological indexes(including skin moisture content， skin oil and pH value)， serum interleukin(IL-2， IL-4， IL-10) as well as interferon(INF-γ) being tested before and after treatment to evaluate the clinical therapeutic effects of both groups. RESULTS Scores of lesion extent， lesion amount， lesion color， lesion swelling and pain as well as total lesion scores and TCM symptom scores of both groups went down significantly(P<0.01)， with the observation group being better than the control group(P<0.01). The total therapeutic effect rate of observation group was 90.2%， notably higher than 66.7% of the control group(P<0.01); Heart， liver and kidney function， together with blood routine test and urine routine test of the both groups were within the normal range， with no side effects being noticed. The skin moisture extent of the two groups after treatment went up evidently(P<0.01)， whereas the skin oil went down significantly(P<0.01). The two groups enjoyed evidently increased level of IL-2 and INF-γ after treatment (P<0.01) and decreased level of IL-4 and IL-10(P<0.01). while the recurrence rate of the observation group either four weeks or eight weeks after treatment was much lower than that of the control group(P<0.05). CONCLUSION Qingre Chushi Jiedu Formula can efficiently improve the clinical symptoms of patients with acne due to damp-heat accumulation in spleen and stomach and reduce the recurrence rate， whose mechanism might be related to the improvement of patients' skin physiological indexes and immune function.