PMID- 36038984
OWN - NLM
STAT- MEDLINE
DCOM- 20230124
LR  - 20230202
IS  - 1525-1470 (Electronic)
IS  - 0736-8046 (Linking)
VI  - 40
IP  - 1
DP  - 2023 Jan
TI  - A randomized, observer-blind, vehicle-control, multi-center clinical 
      investigation for assessing the efficacy and tolerability of a 1% ectoine and 
      hyaluronic acid 0.1%-containing medical device in pediatric patients with 
      mild-to-moderate atopic dermatitis.
PG  - 78-83
LID - 10.1111/pde.15117 [doi]
AB  - BACKGROUND: Ectoine is a widespread osmolyte enabling halophilic bacteria to 
      withstand high osmotic stress that has many potential applications ranging from 
      cosmetics to its use as a therapeutic agent. OBJECTIVE: The aim of this study was 
      to compare the efficacy and tolerability of ectoine 1% and hyaluronic acid 0.1% 
      containing (EHA) cream with a vehicle cream in children with mild-to-moderate 
      atopic dermatitis (AD). METHODS: A randomized, controlled, observer-blind, 
      multicenter clinical trial was conducted in children aged 2-18 years, diagnosed 
      with mild-to-moderate AD (SCORAD </=20). Patients were randomized to either 
      receiving EHA cream or vehicle cream twice daily for 4 weeks. The primary outcome 
      measure was the mean change in objective SCORAD from baseline to the final visit. 
      The secondary outcome measures included the mean change in Investigator's Global 
      Assessment score, patient's judgment of efficacy and patient's assessment of 
      pruritus. Safety of EHA cream was also assessed. RESULTS: A total of 70 patients 
      (35 in each group) were randomized and 57 were included in the final analysis 
      set. Based on SCORAD measurements, patients using EHA cream achieved superior 
      clinical improvement compared to the control group at 28 days (p < .001). EHA 
      cream was also superior to the vehicle cream regarding all secondary outcome 
      measures. Eight (23.5%) patients receiving EHA cream and two (5.7%) patients 
      receiving vehicle cream experienced mild cutaneous adverse events (AEs). 
      CONCLUSIONS: In children 2-18 years old with mild-to-moderate AD, EHA cream was 
      superior to vehicle cream, with minor AEs.
CI  - (c) 2022 Wiley Periodicals LLC.
FAU - Alexopoulos, Alex
AU  - Alexopoulos A
AD  - Pediatric Dermatology Unit, First Department of Pediatrics, National and 
      Kapodistrian University of Athens, "Aghia Sophia" Children's Hospital, Athens, 
      Greece.
FAU - Dakoutrou, Maria
AU  - Dakoutrou M
AUID- ORCID: 0000-0002-8317-8298
AD  - Pediatric Dermatology Unit, First Department of Pediatrics, National and 
      Kapodistrian University of Athens, "Aghia Sophia" Children's Hospital, Athens, 
      Greece.
FAU - Nasi, Lamprini
AU  - Nasi L
AD  - Pediatric Dermatology Unit, First Department of Pediatrics, National and 
      Kapodistrian University of Athens, "Aghia Sophia" Children's Hospital, Athens, 
      Greece.
FAU - Thanopoulou, Ioanna
AU  - Thanopoulou I
AD  - Pediatric Dermatology Unit, First Department of Pediatrics, National and 
      Kapodistrian University of Athens, "Aghia Sophia" Children's Hospital, Athens, 
      Greece.
FAU - Kakourou, Talia
AU  - Kakourou T
AD  - Pediatric Dermatology Unit, First Department of Pediatrics, National and 
      Kapodistrian University of Athens, "Aghia Sophia" Children's Hospital, Athens, 
      Greece.
FAU - Kontara, Louiza
AU  - Kontara L
AD  - Pediatric Department, Kingston Hospital, London, UK.
FAU - Douladiris, Nikolaos
AU  - Douladiris N
AD  - Allergy Department, Second Pediatric Clinic, National and Kapodistrian University 
      of Athens, Athens, Greece.
FAU - Galani, Maria
AU  - Galani M
AD  - Allergy Department, Second Pediatric Clinic, National and Kapodistrian University 
      of Athens, Athens, Greece.
FAU - Xepapadaki, Paraskevi
AU  - Xepapadaki P
AD  - Allergy Department, Second Pediatric Clinic, National and Kapodistrian University 
      of Athens, Athens, Greece.
FAU - Doxani, Chrysoula
AU  - Doxani C
AD  - Department of Biomathematics, School of Medicine, University of Thessaly, 
      Larissa, Greece.
FAU - Mprotsis, Theodoros
AU  - Mprotsis T
AD  - Department of Biomathematics, School of Medicine, University of Thessaly, 
      Larissa, Greece.
FAU - Zintzaras, Elias
AU  - Zintzaras E
AD  - Department of Biomathematics, School of Medicine, University of Thessaly, 
      Larissa, Greece.
AD  - The Institute for Clinical Research and Health Policy Studies, Tufts Medical 
      Center, Tufts University School of Medicine, Boston, Massachusetts, USA.
FAU - Papadopoulos, Nikolaos G
AU  - Papadopoulos NG
AD  - Allergy Department, Second Pediatric Clinic, National and Kapodistrian University 
      of Athens, Athens, Greece.
FAU - Kanaka-Gantenbein, Christina
AU  - Kanaka-Gantenbein C
AD  - First Department of Pediatrics, National and Kapodistrian University of Athens, 
      "Aghia Sophia" Children's Hospital, Athens, Greece.
FAU - Chrousos, George P
AU  - Chrousos GP
AD  - First Department of Pediatrics, National and Kapodistrian University of Athens, 
      "Aghia Sophia" Children's Hospital, Athens, Greece.
AD  - University Research Institute of Maternal and Child Health and Precision Medicine 
      and UNESCO Chair on Adolescent Health Care, National and Kapodistrian University 
      of Athens, "Aghia Sophia" Children's Hospital, Athens, Greece.
LA  - eng
GR  - BODERM SA/
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20220829
PL  - United States
TA  - Pediatr Dermatol
JT  - Pediatric dermatology
JID - 8406799
RN  - 7GXZ3858RY (ectoine)
RN  - 9004-61-9 (Hyaluronic Acid)
RN  - 0 (Amino Acids, Diamino)
RN  - 0 (Emollients)
SB  - IM
MH  - Humans
MH  - Child
MH  - Child, Preschool
MH  - Adolescent
MH  - *Dermatitis, Atopic/drug therapy
MH  - Hyaluronic Acid/adverse effects
MH  - *Amino Acids, Diamino/adverse effects
MH  - Pruritus/drug therapy
MH  - Emollients/adverse effects
MH  - Double-Blind Method
MH  - Treatment Outcome
MH  - Severity of Illness Index
OTO - NOTNLM
OT  - atopic dermatitis
OT  - child
OT  - ectoine
OT  - eczema
EDAT- 2022/08/31 06:00
MHDA- 2023/01/25 06:00
CRDT- 2022/08/30 00:13
PHST- 2021/07/20 00:00 [received]
PHST- 2022/07/29 00:00 [accepted]
PHST- 2022/08/31 06:00 [pubmed]
PHST- 2023/01/25 06:00 [medline]
PHST- 2022/08/30 00:13 [entrez]
AID - 10.1111/pde.15117 [doi]
PST - ppublish
SO  - Pediatr Dermatol. 2023 Jan;40(1):78-83. doi: 10.1111/pde.15117. Epub 2022 Aug 29.