Local rhamnosoft, ceramides and L-isoleucine in atopic eczema

A randomized, placebo controlled trial

Alessia Marseglia, Amelia Licari, Fabio Agostinis, Antonio Barcella, Domenico Bonamonte, Mario Puviani, Massimo Milani, Gianluigi Marseglia

Research output: Contribution to journalArticle

10 Citations (Scopus)

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 a 4-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. Conclusion: 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. (Clinical trial Registry: NTR4084).

Original languageEnglish
Pages (from-to)271-275
Number of pages5
JournalPediatric Allergy and Immunology
Volume25
Issue number3
DOIs
Publication statusPublished - 2014

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Isoleucine
Ceramides
Atopic Dermatitis
Adenosine Monophosphate
Eczema
Randomized Controlled Trials
Placebos
Emollients
Control Groups
Therapeutics
Registries
Anti-Inflammatory Agents
Research Personnel
Clinical Trials

Keywords

  • Assessor-blinded
  • Atopic eczema
  • Emollient therapy
  • Randomized trial

ASJC Scopus subject areas

  • Immunology and Allergy
  • Pediatrics, Perinatology, and Child Health
  • Immunology

Cite this

Local rhamnosoft, ceramides and L-isoleucine in atopic eczema : A randomized, placebo controlled trial. / Marseglia, Alessia; Licari, Amelia; Agostinis, Fabio; Barcella, Antonio; Bonamonte, Domenico; Puviani, Mario; Milani, Massimo; Marseglia, Gianluigi.

In: Pediatric Allergy and Immunology, Vol. 25, No. 3, 2014, p. 271-275.

Research output: Contribution to journalArticle

Marseglia, A, Licari, A, Agostinis, F, Barcella, A, Bonamonte, D, Puviani, M, Milani, M & Marseglia, G 2014, 'Local rhamnosoft, ceramides and L-isoleucine in atopic eczema: A randomized, placebo controlled trial', Pediatric Allergy and Immunology, vol. 25, no. 3, pp. 271-275. https://doi.org/10.1111/pai.12185
Marseglia, Alessia ; Licari, Amelia ; Agostinis, Fabio ; Barcella, Antonio ; Bonamonte, Domenico ; Puviani, Mario ; Milani, Massimo ; Marseglia, Gianluigi. / Local rhamnosoft, ceramides and L-isoleucine in atopic eczema : A randomized, placebo controlled trial. In: Pediatric Allergy and Immunology. 2014 ; Vol. 25, No. 3. pp. 271-275.
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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 a 4-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. Conclusion: 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. (Clinical trial Registry: NTR4084).",
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T1 - Local rhamnosoft, ceramides and L-isoleucine in atopic eczema

T2 - A randomized, placebo controlled trial

AU - Marseglia, Alessia

AU - Licari, Amelia

AU - Agostinis, Fabio

AU - Barcella, Antonio

AU - Bonamonte, Domenico

AU - Puviani, Mario

AU - Milani, Massimo

AU - Marseglia, Gianluigi

PY - 2014

Y1 - 2014

N2 - 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 a 4-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. Conclusion: 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. (Clinical trial Registry: NTR4084).

AB - 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 a 4-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. Conclusion: 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. (Clinical trial Registry: NTR4084).

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