Background: Elastargene 3C (E3C) is a cream specifically designed to improve lipoatrophy in patients with diabetes. It is made by many ingredients, among whom are elastin, arnica, collagen, caffeine, and L-carnitine.
Objective and hypotheses: We started a 6-month, double-blind, randomized trial to test the efficacy of E3C in children with type 1 diabetes (T1D) using insulin pump (CSII), in whom infusion set usually left little withe scars.
Method: Forty children and adolescents using CSII, were randomized into two arms: i) n=20 E3C once a day on the skin of abdomen or other sites where infusion sets have been placed, administered before sleeping; ii) n=20 placebo once a day on the skin of abdomen or other sites where infusion sets have been placed, administered before sleeping. BMI, HbA1c, and insulin requirement were determined in each child before at baseline and after 6 months.
Results: At the end of the study, five patients dropped using the E3C or placebo and were excluded from the analysis. In elastargene group, 18 patients with T1D were evaluated: age 15.2±4.8 years, diabetes duration 8.0±5.3, time using a pump 4.1±3.0; in the placebo group, 17 patients with T1D were evaluated: age 15.1±5.7 years, diabetes duration 8.3±5.8, time using a pump 4.7±3.0. No significant difference has been observed for age, disease duration, and time since insulin pump started. HbA1c significantly improved in patients using E3C (baseline 8.08±0.80%, after 6 months 7.51±0.53%, P=0.005, Δ −0.53%), but not in placebo group (baseline 7.98±0.74%, after 6 months 7.76±0.79%, P=0.19, Δ −0.22%). No difference has been observed regarding BMI or insulin requirement. In the E3C group, withe scars completely disappeared in eight patients and improved in ten; in the placebo group withe scars did not change in any of the patients.
Conclusion: To our knowledge this is the first time that a direct effect of E3C have been shown in improving little withe scars that appear on the skin after infusion set removal in children with T1D using CSII. Moreover, HbA1c significantly improved only in the E3C group, probably because improved insulin absorption.
01 Oct 2015 - 03 Oct 2015