Atopic Dermatitis in Atopy Predisposed Infants (ADAPI)
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|ClinicalTrials.gov Identifier: NCT02906475|
Recruitment Status : Active, not recruiting
First Posted : September 20, 2016
Last Update Posted : March 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Dermatitis, Atopic||Other: standardized skin care regimen||Not Applicable|
Atopic dermatitis is the most common cutaneous disease in childhood. First manifestations of AD usually appear early in life after the 3rd month of life and often precede other allergic diseases such as asthma or allergic rhinitis. AD affects over 15% of children up to school age in Germany and has a substantial impact on the lives and life quality of both the child and its family. Taking into account the burden on health-care resources, the impact on the quality of life of patients and their caregivers, together with increasing evidence that AD may progress to other allergic phenotypes, there is a clear need to improve disease prevention. Due to the childhood prevalence of the disease, prevention is focused on the postnatal period. It is recognized that prevention should start as soon as possible. Current studies suggest that epidermal barrier impairment is an important factor for the development of AD and other allergic diseases, with the gene encoding the filament-binding protein filaggrin (FLG) being the most widely replicated and most significant gene to influence atopic diseases. Currently, no standardized recommendations for preventive therapies exist for AD. Pilot studies have focused on interventions to enhance skin barrier function. Daily skin care with an emollient early after birth is considered to reduce the risk of atopic dermatitis in infants.
The study will be divided in 2 parts: The main study (Interventional period) lasts up to the child´s age of one year (52 weeks of life) and the follow-up period up to the second birthday.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized Pragmatic Parallel Group Trial to Investigate the Effectiveness of a Standardized Skin Care Regimen to Prevent the Development of Atopic Dermatitis in Atopy Predisposed Infants|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2020|
Intervention: standardized skin care regimen
Intervention: The milk lotion will be applied once daily on the total body including the face by the parents or care givers at home. If bathing is needed, the bathing addendum is used in addition to water.
Other: standardized skin care regimen
Application of a standardized daily skin care regimen:
No Intervention: Control
In the control group no predetermined or standardized skin care regimen is prescribed.
- Cumulative incidence of atopic dermatitis [ Time Frame: 12 months ]Cumulative incidence of AD at week 52, with AD diagnosis based on the criteria by Simpson et al. 2012
- Cumulative incidence of atopic dermatitis [ Time Frame: 24 months ]
- AD incidence density [ Time Frame: 12 months ]
- AD incidence density [ Time Frame: 24 months ]
- Eczema Area and Severity Index (EASI) [ Time Frame: 12 months ]
- Eczema Area and Severity Index (EASI) [ Time Frame: 24 months ]
- Infant Dermatitis Quality of Life (IDQoL) [ Time Frame: 12 months ]
- Infant Dermatitis Quality of Life (IDQoL) [ Time Frame: 24 months ]
- Transepidermal water loss (TEWL) on the midvolar forearm [ Time Frame: at ages of 14 days, 1, 3, 6, 12 months and 2 years ]
- Skin surface pH on the midvolar forearm [ Time Frame: at ages of 14 days, 1, 3, 6, 12 months and 2 years ]
- Stratum Corneum Hydration (SCH) on the forearm [ Time Frame: at ages of 14 days, 1, 3, 6, 12 months and 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02906475
|Charite Universitätsmedizin Berlin|
|Berlin, Germany, 10117|
|Principal Investigator:||Ulrike Blume-Peytavi, Prof. Dr.||Charite Universitätsmedizin Berlin|