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Official Journal of the Italian Society of Dermatology and Sexually Transmitted Diseases
Indexed/Abstracted in: EMBASE, PubMed/MEDLINE, Science Citation Index Expanded (SciSearch), Scopus
Impact Factor 1,014
Online ISSN 1827-1820
De Waure C. 1, Cadeddu C. 1, Venditti A. 1, Barcella A. 2, Bigardi A. 3, Masci S. 4, Virno G. 5, Cammisa A. 6, Ricciardi W. 1
1 Institute of Public Health Sacro Cuore Catholic University, Rome, Italy;
2 Private Practiotioner, Bergamo, Italy;
3 Private Practitioner, Milan, Italy;
4 Private Practitioner, Pescara, Italy;
5 Private Practitioner, Ventimiglia, Imperia, Italy;
6 Scientific Board Drex Pharma, Milan, Italy
Aim: This study assesses the efficacy of a new non steroid anti-inflammatory product in comparison to Hydrocortisone Butyrate 0.1% Cream in healing eczematous dermatitis.
Methods: A bilateral controlled randomized pilot study was conducted in Italian adults affected by eczema with at least two symmetric lesions at baseline, respectively assigned to a non steroid cream or Hydrocortisone. The severity of lesions was judged through the Global Clinical Score (GCS) and the recovery was defined as a GSC equal to 0. The study investigated: 1) the differences in GCS between four points in time during therapy (baseline, four, eight, twelve weeks), according to medication received; 2) treatment efficacy.
Results: The study showed that time, treatment and interaction between treatment and time were associated with GCS; moreover, lesions treated with Hydrocortisone went better on the whole but the post-hoc analysis showed a significant clinical improving at each point in time only for the non steroid cream. At the end of the study, in the intention to treat analysis, lesions recovered in 76.1% and 40.3% patients treated with Hydrocortisone and with the non steroid cream respectively; in the per protocol population, recovery was achieved in 91.7% and 58.3% of cases.
Conclusion: According to the results, the non steroid cream has been demonstrated effective in reducing the severity of eczema and may be used with continuing success in the long term treatment of the disease.