title: Local rhamnosoft, ceramides and L-isoleucine in atopic eczema: a randomized, placebo controlled trial.
abstract: BACKGROUND
  A non-steroidal, anti-inflammatory moisturizing cream containing rhamnosoft, ceramides, and L-isoleucine (ILE) (pro-AMP cream) has been recently developed for the specific treatment of atopic eczema (AE) of the face. In this trial, we evaluated the clinical efficacy and tolerability of pro-AMP cream in the treatment of facial AE in children in comparison with an emollient cream.
  
  
  METHODS
  In a randomized, prospective, assessor-blinded, parallel groups (2:1) controlled trial, 107 children (72 allocated to pro-AMP cream and 35 allocated to control group) with mild-to-moderate chronic AE of the face were enrolled. Treatments were applied twice daily for a 6-week period. Facial Eczema Severity Score (ESS) was evaluated at baseline, week 3, and week 6, by an assessor unaware of treatment allocation. Investigator’s Global Assessment (IGA) score was assessed at week 3 and at week 6. Tolerability was evaluated at week 3 and at week 6 using a4-point score (from 0: low tolerability to 3: very good tolerability).
  
  
  RESULTS
  At baseline ESS, mean (SD) was 6.1 (2.4) in the pro-AMP cream group and 5.3 (3) in the control group. In the pro-AMP group, in comparison with baseline, ESS was significantly reduced to 2.5 (-59%) after 3 wks and to 1.0 (-84%) at week 6 (p = 0.0001). In the control group, ESS was reduced to 3 (-42%) at week 2 and to 2.6(-50%) at week 6. At week 6, ESS in pro-AMP cream was significantly lower than the control group (1.0 vs. 2.6; p = 0.001). Both products were well tolerated.
  
  
  CONCLUSIONS
  Pro-AMP cream has shown to be effective in the treatment of mild-to moderate chronic lesion of AE of the face. Clinical efficacy was greater in comparison with an emollient cream. (
  
  
  BACKGROUND
  NTR4084).
authors.forename: Alessia
authors.initials: A
authors.lastname: Marseglia
authors.forename: Amelia
authors.initials: A
authors.lastname: Licari
authors.forename: Fabio
authors.initials: F
authors.lastname: Agostinis
authors.forename: Antonio
authors.initials: A
authors.lastname: Barcella
authors.forename: Domenico
authors.initials: D
authors.lastname: Bonamonte
authors.forename: Mario
authors.initials: M
authors.lastname: Puviani
authors.forename: Massimo
authors.initials: M
authors.lastname: Milani
authors.forename: GianLuigi
authors.initials: G
authors.lastname: Marseglia
mesh_terms: D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D002518:Ceramides / Q000008:administration & dosage*; D002675:Child, Preschool; D004338:Drug Combinations; D004485:Eczema / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007223:Infant; D007532:Isoleucine / Q000008:administration & dosage*; D008297:Male; D009824:Ointments; D011134:Polysaccharides / Q000008:administration & dosage*; D011446:Prospective Studies; D012210:Rhamnose / Q000008:administration & dosage*
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D002518:Ceramides; D004338:Drug Combinations; D009824:Ointments; D011134:Polysaccharides; D007532:Isoleucine; D012210:Rhamnose
references.citation: J Invest Dermatol. 1991 Apr;96(4):523-6
references.pmid: 2007790
references.citation: Semin Dermatol. 1992 Jun;11(2):176-82
references.pmid: 1498022
references.citation: Mol Immunol. 2010 Mar;47(6):1378-82
references.pmid: 20022113
references.citation: Asian Pac J Allergy Immunol. 2013 Jun;31(2):91-8
references.pmid: 23859407
references.citation: Clin Rev Allergy Immunol. 2011 Dec;41(3):282-95
references.pmid: 21174234
references.citation: West J Med. 1999 Nov-Dec;171(5-6):351-3
references.pmid: 10639873
references.citation: J Allergy Clin Immunol. 2008 Mar;121(3):725-730.e2
references.pmid: 18249438
references.citation: Int J Dermatol. 2014 Jan;53(1):27-33
references.pmid: 23879225
references.citation: Dermatology. 2007;214(1):61-7
references.pmid: 17191050
references.citation: Allergy. 2004 Aug;59 Suppl 78:61-5
references.pmid: 15245360
references.citation: Pediatr Allergy Immunol. 2008 Nov;19(7):619-25
references.pmid: 18298424
references.citation: Allergy Asthma Proc. 2013 Jan-Feb;34(1):78-83
references.pmid: 23406940
references.citation: Contact Dermatitis. 2013 Aug;69(2):65-71
references.pmid: 23869725
references.citation: J Dermatol. 2013 Mar;40(3):160-71
references.pmid: 23289827
references.citation: Arch Dermatol. 2001 Aug;137(8):1079-81
references.pmid: 11493102
references.citation: Exp Dermatol. 2001 Feb;10(1):11-8
references.pmid: 11168575
references.citation: J Cosmet Dermatol. 2011 Sep;10(3):185-8
references.pmid: 21896129
references.citation: Am J Clin Dermatol. 2013 Oct;14(5):389-99
references.pmid: 23757122
references.citation: J Allergy Clin Immunol. 2008 Jun;121(6):1337-43
references.pmid: 18329087
references.citation: Drugs R D. 2013 Mar;13(1):37-42
references.pmid: 23456759
references.citation: J Allergy Clin Immunol. 2008 Oct;122(4):689-693
references.pmid: 18774165
references.citation: Exp Dermatol. 2008 Dec;17(12):1063-72
references.pmid: 19043850
references.citation: J Dermatolog Treat. 2013 Apr;24(2):122-5
references.pmid: 22812593
references.citation: J Drugs Dermatol. 2011 May;10(5):531-7
references.pmid: 21533301
references.citation: Br J Dermatol. 2013 Jun;168(6):1339-42
references.pmid: 23301666
references.citation: N Engl J Med. 2008 Apr 3;358(14):1483-94
references.pmid: 18385500
references.citation: N Engl J Med. 2002 Oct 10;347(15):1151-60
references.pmid: 12374875
references.citation: Proc Natl Acad Sci U S A. 2000 Nov 7;97(23):12723-8
references.pmid: 11058160
references.citation: Curr Opin Allergy Clin Immunol. 2009 Oct;9(5):437-46
references.pmid: 19550302
references.citation: J Eur Acad Dermatol Venereol. 2010 Mar;24(3):317-28
references.pmid: 19732254
references.citation: Pediatr Dermatol. 2012 Nov-Dec;29(6):714-8
references.pmid: 23106672
references.citation: Pathol Biol (Paris). 2006 Sep;54(7):420-5
references.pmid: 16919895
references.citation: Dermatol Ther. 2012 May-Jun;25(3):229-33
references.pmid: 22913439
references.citation: Mol Immunol. 2006 Apr;43(10):1617-23
references.pmid: 16263169