Abstract
Objective: To analyze compounded recombinant human epidermal growth factor (rhEGF) effectiveness on skin lesions through a case series.
Design: Multicentric series of skin lesions treated with topical rhEGF.
Site: Patients from 56 different health professionals, three different countries, and two recruitment years.
Participants: Seventy-seven patients with skin lesions, mean age of 63.15 years (min = 18, max = 95); 53.2% of patients were men and 46.8% were women; 47 of the lesions were ulcers (venous, arterial, and diabetic foot), others were surgical and traumatic wounds, burns, and scars. Most common pathologies were type 2 diabetes mellitus and chronic venous insufficiency. Mean previous evolution time before inclusion was 29.59 months.
Interventions: Cures using compounded topical rhEGF most commonly used rhEGF concentration: 30 μg/g; most used excipient: gel; average time between cures: 36 h (24–48); and mean follow-up: 6.6 weeks (max = 20).
Main measurements: Lesions appearance, margins and bed, lesional size evolution, treatment subjective effectiveness, tolerability and comfort through professional oppinion.
Results: Qualitative assessment: effectiveness 8.65, tolerability 9.53, and comfort 8.86 (max = 10). Perilesional skin showed improvement in 93.5% of the cases, lesions margins and wound bed appearance improved in 92.2% of the cases, respectively. Wound area decreased a mean average of 66.7%. About 43.3% of included venous ulcers had a greater than 40% cure rate in 4 weeks.
Limitations: Heterogeneity of the included pathologies, limited time follow-up in some cases.
Conclusions: Topical rhEGF in individualized formulation (compounding) seems to exhibit effectiveness, comfort, and tolerability. Further larger-size studies with experimental design will allow to establish more precise concentrations, indications, and clinical guidelines.
Acknowledgments
The authors would like to thank Fagron Ibérica S.A.U. for its scientific collaboration in supporting and collaborating with this project.