A prospective clinical investigation of Epaderm® Cream to confirm the performance and safety in adult and paediatric patients with eczema, psoriasis and other dry skin conditions by August S., Granier S., Tighe M., Tbaily L. 2020, data on file.
Introduction and objectives
A prospective clinical study to assess the performance and safety of an emollient and cleanser made from 25% (w/w) paraffin for softening, moisturising, reducing skin water loss, and 5% (w/w) glycerine for hydration. This was used across a wide range of ages including infants. The objectives were the subject’s clinical evaluations and safety parameters.
Materials and Methods
A prospective, non-randomised, single-arm clinical investigation was divided into three groups; infants (0-36 months), children (3-18 years) and adults (> 18 years). Each subject was followed over 4 weeks, with a visit at baseline, week 2, and 4. Statistical analysis of the data was performed.
By week 2 and week 4:
- 84% of subjects, strongly agreed or agreed that the cream improved skin moisture
- 86% of subjects, strongly agreed or agreed that there was an improvement in skin softness.
- The skin was well hydrated after treatment
- Overall the cream was rated ‘good’ or ‘excellent’ by the patients or their parents in 88.5% of infants and 83.2% of all patients
- Epaderm Cream was well tolerated across all groups including infants.
- The cream improved skin moisturisation and softness over two weeks in all age groups across all indications.
- The cream, based on feedback from subjects and clinicians, performed well in terms of dry skin/xerosis, skin hydration and itching.