Garcia Bartels 2011.

Study characteristics
Methods	Study design: monocentric, prospective, randomised, clinical non‐pharmaceutical study  Study conducted: September to December 2009 Treatment arms: 2 AD follow‐up: 4 weeks
Participants	Randomised: N = 44 (Group L using lotion n = 20; Group WL without lotion n = 24) Inclusion criteria:  Healthy full‐term infant (37 weeks+) Aged 3 to 6 months Parental consent  Exclusion criteria:  Immunocompromised infant Severe illness  Congenital skin disorder Skin irritation that could have affected measurements or was contagious Current or previous atopic dermatitis in both parents Acute or chronic illness with increased or decreased body temperature Participation in another study
Interventions	Both groups went swimming weekly for 4 weeks for 25 to 40 minutes at the Charité‐Universitätsmedizin Berlin physiotherapy facilities. Both groups received a standard skin care regimen: weekly bathing in tap water, diaper care with water and cotton cloth or Bübchen® Comfort sensitive wipes. No skin care was performed 12 hours before evaluations Intervention: in group L (lotion group), baby skin care lotion was applied to the entire body once weekly after swimming and the skin was dried with a towel Comparator: no lotion or other skin care product was applied in Group WL (without lotion)  Moisturiser/Emollient ingredients: Bübchen® Pflege Lotion: aqua, Helianthus annuus seed oil, isopropyl palmitate, dicaprylyl ether, ethylhexyl stearate, polyglyceryl‐3 polyricinoleate, glycerin, butylene glycol, octyldodecanol, polyglyceryl‐3 diisostearate, parfum, zinc stearate, chamomilla‐recutita extract, tocopheryl acetate, glyceryloleate, magnesium sulfate, tocopherol
Outcomes	Transepidermal water loss Stratum corneum hydration Skin pH Sebum  Measured on 4 anatomical test areas (forehead, abdomen, buttock, thigh), using the non‐invasive Multi‐Probe Adapter System MPA® (Courage & Khazaka Electronic, GmbH, Cologne, Germany) at 6 study visits. Baseline visit (V0) was within 4 weeks before the first swimming session. After baseline, visits were performed weekly before swimming sessions (V1 to V4). No swimming took place at follow‐up, 1 week after the last swimming session (V5) Adverse events: method of collection of adverse events is not recorded "Neonatal skin condition score (NSCS) was found to be mainly normal (score 3). A mildly elevated NSCS (4) was found in < 7.5% of infants per visit, and depending on area, an NSCS of 5 was found only once at baseline visit on the thigh (data not shown). NSCS was statistically comparable at all test regions in both groups throughout the study period (n = 44). The overall occurrence of adverse events (AEs) was lower in group L (n = 18) than in group WL(n = 33, Table 3). The occurrence of diaper dermatitis, however, was similar in both groups (n = 9). After dichotomisation of subjects into the two groups “no AE at all” vs “at least one AE”,  χ² test showed significantly less occurrence of AEs in group L compared to group WL (55.0% vs 83.3%; P = 0.04; Figure 8)"
Identification	Country: Germany Setting: Charité‐Universitätsmedizin Berlin, Germany, physiotherapy facilities Sponsorship source: the clinical study was sponsored by Bübchen Deutschland
Declarations of interest	Prof. Blume‐Peytavi has received presentation fees from Bübchen Deutschland, which sponsored the study
Notes