A controlled clinical study on the new topical dosage form of DHEP plasters in patients suffering from localized inflammatory diseases.

In this clinical study the efficacy and the tolerability of a new topical formulation, DHEP plaster, have been evaluated. The plaster consists of an auto-adhesive medicated gauze pad of standard dimensions (10 x 15 cm) containing 180 mg DHEP. The reference drug was a well-known topical drug, diclofenac diethylammonium (DDA) emulgel at 1.16%. Treatments were applied to the affected area for 14 days: DHEP plaster b.i.d. and DDA emulgel q.i.d. A total of 190 patients, affected by various inflammatory diseases, participated in this clinical study. In both treatment groups (DHEP n = 96 patients, DDA n = 94 patients) a clear improvement in the disease and a rapid reduction in pain were observed. The statistical comparison between the two treatments showed a significant difference in favour of DHEP. However a comparison of the results, according to the different diagnoses, did not reveal any statistical significance. Both treatments were well tolerated, although five (DHEP n = 2, DDA n = 3) out of the 190 patients (2.6%) showed transient side effects (pruritus or erythema, both of light intensity).

RCT Entities:   Population Interventions Outcomes