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Local rhamnosoft, ceramides and L-isoleucine in atopic eczema: a randomized, placebo controlled trial.

Marseglia A, Licari A, Agostinis F, Barcella A, Bonamonte D, Puviani M, Milani M, Marseglia G - Pediatr Allergy Immunol (2014)

Bottom Line: Both products were well tolerated.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. ( NTR4084).

View Article: PubMed Central - PubMed

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.

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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Related in: MedlinePlus

(a) Evolution of Eczema severity Score from baseline to week 3 and week 6 in the two study groups. Data presented as mean ± SEM. *p < 0.001 vs. baseline, **p > 0.001 vs. control cream. (b) Evolution of Investigator Global Assessment (IGA) score at week 3 and week 6 in the two study groups. Data presented as mean ± SEM. *p = 0.0003 vs. control cream.
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fig01: (a) Evolution of Eczema severity Score from baseline to week 3 and week 6 in the two study groups. Data presented as mean ± SEM. *p < 0.001 vs. baseline, **p > 0.001 vs. control cream. (b) Evolution of Investigator Global Assessment (IGA) score at week 3 and week 6 in the two study groups. Data presented as mean ± SEM. *p = 0.0003 vs. control cream.

Mentions: All 107 enrolled patients (59 boy and 48 girls; mean age 6 yr; range 6 months–2 yr) concluded the 6-week study period. Table1 summarizes subjects' characteristics at baseline. Seventy patients were allocated to pro-AMP group and 35 to emollient cream control group. History of AE lasted 6 yr in the pro-AMP group and 5 yr in the control group. The two groups were well balanced regarding the main demographic and medical variables. At baseline ES score, mean (SD) was 6.1 (2.5) in children in the pro-AMP cream group and 5.3 (3) in the control group. In the pro-AMP cream treated group, in comparison with baseline, facial ESS was significantly reduced to 2.5 (2) (representing a 59% reduction) after 3 wks and to 1.0 (1.5) (representing a −84% reduction) at week 6 (p = 0.0001) with an absolute reduction of −5.0 points (95% CI: from −5.5 to −4.5). In the control group, ESS was reduced to 3 (2) (representing a −42% reduction) at week 3 and to 2.6 (2) (−50%) at week 6 with an absolute reduction of −2.7 points (95% CI: from −3.6 to −1.4). At week 6, facial ESS in pro-AMP cream was significantly lower than the control group (1.0 vs. 2.6; p = 0.0001) (Fig. 1a). IGA score was 1.5 and 0.6 at week 3 and 6, respectively, in pro-AMP cream group. In control group, IGA score was 1.6 at week 3 and 1.2 at week 6. IGA score at week 6 was lower in pro-AMP cream group in comparison with control group (0.6 vs. 1.2; p = 0.0003) (Fig. 1b). Treatment success (IGA score ≤1) percentage at week 6 was 88% in pro-AMP group and 58% in the control group (p = 0.009; Fisher's exact test) with a number needed to treat of 3.3 in favor of pro-AMP group. Both products were well tolerated with a tolerability score of 2.8 in pro-amp cream group and 2.9 in the control group (NS).


Local rhamnosoft, ceramides and L-isoleucine in atopic eczema: a randomized, placebo controlled trial.

Marseglia A, Licari A, Agostinis F, Barcella A, Bonamonte D, Puviani M, Milani M, Marseglia G - Pediatr Allergy Immunol (2014)

(a) Evolution of Eczema severity Score from baseline to week 3 and week 6 in the two study groups. Data presented as mean ± SEM. *p < 0.001 vs. baseline, **p > 0.001 vs. control cream. (b) Evolution of Investigator Global Assessment (IGA) score at week 3 and week 6 in the two study groups. Data presented as mean ± SEM. *p = 0.0003 vs. control cream.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4260143&req=5

fig01: (a) Evolution of Eczema severity Score from baseline to week 3 and week 6 in the two study groups. Data presented as mean ± SEM. *p < 0.001 vs. baseline, **p > 0.001 vs. control cream. (b) Evolution of Investigator Global Assessment (IGA) score at week 3 and week 6 in the two study groups. Data presented as mean ± SEM. *p = 0.0003 vs. control cream.
Mentions: All 107 enrolled patients (59 boy and 48 girls; mean age 6 yr; range 6 months–2 yr) concluded the 6-week study period. Table1 summarizes subjects' characteristics at baseline. Seventy patients were allocated to pro-AMP group and 35 to emollient cream control group. History of AE lasted 6 yr in the pro-AMP group and 5 yr in the control group. The two groups were well balanced regarding the main demographic and medical variables. At baseline ES score, mean (SD) was 6.1 (2.5) in children in the pro-AMP cream group and 5.3 (3) in the control group. In the pro-AMP cream treated group, in comparison with baseline, facial ESS was significantly reduced to 2.5 (2) (representing a 59% reduction) after 3 wks and to 1.0 (1.5) (representing a −84% reduction) at week 6 (p = 0.0001) with an absolute reduction of −5.0 points (95% CI: from −5.5 to −4.5). In the control group, ESS was reduced to 3 (2) (representing a −42% reduction) at week 3 and to 2.6 (2) (−50%) at week 6 with an absolute reduction of −2.7 points (95% CI: from −3.6 to −1.4). At week 6, facial ESS in pro-AMP cream was significantly lower than the control group (1.0 vs. 2.6; p = 0.0001) (Fig. 1a). IGA score was 1.5 and 0.6 at week 3 and 6, respectively, in pro-AMP cream group. In control group, IGA score was 1.6 at week 3 and 1.2 at week 6. IGA score at week 6 was lower in pro-AMP cream group in comparison with control group (0.6 vs. 1.2; p = 0.0003) (Fig. 1b). Treatment success (IGA score ≤1) percentage at week 6 was 88% in pro-AMP group and 58% in the control group (p = 0.009; Fisher's exact test) with a number needed to treat of 3.3 in favor of pro-AMP group. Both products were well tolerated with a tolerability score of 2.8 in pro-amp cream group and 2.9 in the control group (NS).

Bottom Line: Both products were well tolerated.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. ( NTR4084).

View Article: PubMed Central - PubMed

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.

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).

Show MeSH
Related in: MedlinePlus