Efficacy and safety of a rosehip seed oil extract in the prevention and treatment of skin lesions in the hands of patients with type 1 diabetes mellitus caused by finger prick blood glucose monitoring; a randomized, open-label, controlled clinical trial

Abstract

Introduction: This study was intended to assess the efficacy and safety of a rosehip seed oil (RHO) extract in the prevention and treatment of skin lesions in the hands of patients with type 1 diabetes mellitus (T1DM) caused by finger prick blood glucose monitoring.

Patients and method: A prospective, randomized, controlled, open-label, rater-blinded trial in patients aged 6-17 years with T1DM and intensive blood glucose control (≥7 finger pricks daily) for 12 days. Three main variables (erythema, skin thickening, and loss of skin integrity) were assessed using a scale ranging from 0 (absent) to 3 (severe involvement). The study was approved by the ethics committee of the hospital.

Results: Sixty-eight children, and thus 136 hands, were included; 80 hands received rosehip seed oil and 56 hands acted as controls. Baseline characteristics of both groups were similar, with 76.3% and 78.6% of the hands respectively showing skin lesions at study start. Median final global assessment was 0.10 (0.03; 0.30) in the group that received rosehip seed oil and 0.06 (0.00; 0.23) in the control group. A statistically significant improvement in global assessment was found in the control group (P=0.049). No significant differences were found when the medians of the other main variables were compared. No adverse effects were recorded.

Conclusion: A high prevalence of skin lesions secondary to finger prick glucose monitoring, most of them mild lesions, was found at study start. Treatment with rosehip seed oil was safe and was not effective for improving skin lesions.

Keywords: Diabetes mellitus tipo 1; Finger prick; Glucemia capilar; Lesiones dermatológicas; Skin lesions; Type 1 diabetes mellitus.