Long-term follow and other similar studies will help to determine whether such a strategy will reduce the burden of other allergic diseases such as asthma and allergic rhinitis. UMIN-CTR: UMIN000028043 Electronic supplementary material The online version of this article (10.1186/s13601-018-0233-8) contains supplementary material, which is available to authorized users. value is calculated by the difference in percentage with a one-sided test. 28?weeks. Discussion This is a novel pragmatic RCT study to examine the efficacy of early aggressive treatment for atopic dermatitis to prevent later food allergy. If our hypothesis is correct, we hope that such a strategy might impact on disease prevention in countries where food allergy is common, and that our Mitoquinone mesylate results might reduce the frequency and associated costs of all food allergies as well as hens egg food allergy. Long-term follow and other similar studies will help to determine whether such a strategy will reduce the burden of other allergic diseases such as asthma and allergic rhinitis. UMIN-CTR: UMIN000028043 Electronic supplementary material The online version of this article (10.1186/s13601-018-0233-8) contains supplementary material, which is available to authorized users. value is calculated by the difference in percentage with a one-sided test. Mitoquinone mesylate The significance level is 0.025. The difference and ratio of these proportions and their 95% confidence intervals for each intervention group will also be calculated. All secondary endpoints will be analyzed using FAS and secondarily using PPS. The details of statistical methods are described in the statistical analysis plan. Interim analysis is conducted with the aim of preventing disadvantages to participants due to excessive efficacy procedures unintended in study treatment. The interim analysis is performed when almost half of the participants finish their assessments for the primary endpoint. The interim analysis is done for primary endpoint and safety endpoints. The study registration for study participants does not stop while conducting the interim analysis. The analysis of primary endpoint is performed along with the primary endpoints analysis. The stopping boundary for the analysis of primary endpoint will be calculated based on the OBrienCFleming type with a LanCDeMets and spending function at the actual information time. For example, the significance levels of effective discontinuation and invalid discontinuation are 0.0015 and 0.2883, respectively, with the interim analysis for 307 participants who are half of the planned study participants. The interim analysis is conducted by a trial statistician of the interim analysis under a closed situation. The statistician prepares a report of interim analysis results and submits it to the independent data monitoring committee. The results of the interim analysis will be evaluated by the members of the independent data monitoring committee to investigate whether or not the study continues, and the investigation result report is submitted to the principle investigator. Monitoring and ethics This study follows the Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects and the Ethical Guidelines for Medical and Health Research Involving Human Subjects (2014 December 22, the Japanese Ministry of Education, Ministry of Health, Labour and Welfare Notification No. 3). PACI TPOR Study has been approved by IRB of National Center for Child Health and Development (No. 1347) and each investigational site. Details are described in Additional file 1. Discussion Potential benefits of study To our knowledge, this would be the first pragmatic RCT study to examine the efficacy of early aggressive intervention for AD to prevent later FA. If Mitoquinone mesylate we establish a novel new strategy for prevention of FA development by early aggressive intervention for AD, it is expected that quality of life in patients will improve, the prevalence of FA will decrease, and the medical care cost will be reduced. In addition, we are doing follow-up cohort study, PACI-On Study, after the PACI Study. We will observe the participants until they reach to 6?years old. From the results of the PACI-On Study, we will reveal that natural course of allergic diseases could be changed by this early aggressive intervention. Potential study harms Although we use TCSs approved officially in daily basis, we should consider the safety of TCSs. TCSs are topical anti-inflammatory agents and they are safer than systemic steroids administered via an oral or intravenous route. Absorption of TCS in the skin is considered to depend on many factors such as molecular weight of TCS, cream or ointment bases,.