Efficacy Evaluation of a Pollen Blocker Cream against Dust-Mite Allergy: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Crossover Trial

Author:

Li Yanqing1,Cheng Lei2,Chen Xiaoning3,Yang Beibei4,Wang Dehui1

Affiliation:

1. Department of Otolaryngology, the ENT Hospital, Fudan University, Shanghai, China

2. Department of Otolaryngology, the First Affiliated Hospital, Nanjing Medical University, Nanjing, China

3. Department of Otolaryngology, the Traditional Chinese Medicine Hospital of Jiangsu Province, Nanjing, China

4. Department of Otolaryngology, the Second Affiliated Hospital, Zhejiang University, Hangzhou, China

Abstract

Objective To further evaluate the efficacy and safety of a pollen blocker cream against dust-mite allergy. Methods A multicenter, randomized, double-blind, placebo-controlled, crossover trial was conducted in a Chinese population. Patients diagnosed with perennial allergic rhinitis, sensitive to dust-mite allergy including Dermatophagoides farinae and Dermatophagoides pteronyssinus were randomly allocated to receive a pollen blocker cream or placebo, which was applied and spread evenly to the lower internal nose region three times daily for a total of 30 days. The primary outcome measurements for efficacy were total nasal symptom score (TNSS) and individual nasal symptom score (iNSS). Adverse events were also monitored. Results After application of a pollen blocker, the mean TNSS decreased from 23.1 to 13.8, the decrease of the pollen blocker group (9.3) was highly significant compared with the placebo group (5.2; p < 0.001). Similarly, the decreases in iNSSs (rhinorrhea, congestion, sneezing, and itching) between the pollen blocker group and the placebo group were also significant (p < 0.05). In addition, in adults, the pollen blocker led to a remarkably significant decrease in TNSS (9.5) compared with placebo (5.4; p < 0.001); in children, the pollen blocker led to a significant decrease in TNSS (8.6) compared with placebo (4.8; p < 0.05). No statistical difference was found in the incidence of adverse events between the two groups (p > 0.05), and no severe systematic reactions were observed. Conclusion Pollen Blocker is a safe and effective alternative to the drugs for treatment of AR, especially for Chinese people allergic to dust-mite allergy.

Publisher

SAGE Publications

Subject

General Medicine,Otorhinolaryngology,Immunology and Allergy

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