Objective: To investigate the local tolerability of an innovative formulation of 0.25% thiocolchicoside foam in comparison with a commercially available 0.25% thiocolchicoside cream after epicutaneous application in healthy subjects. Design: Single-centre, non-blind, two-period, randomised, crossover trial. Setting: Bourn Hall Clinic in Bourn, Cambridge, UK. Study participants: 25 healthy volunteers (including one replacement subject): 13 females and 12 males, age range 21 to 56 years. Interventions: Application of either thiocolchicoside foam or cream three times daily for 5 days on a 15 × 10cm area on the upper back of each subject. Main outcome measures and results: The primary endpoint was the local tolerability of the foam formulation in comparison with the reference product. Both products were well tolerated and no serious or severe adverse events were observed. A maculopapular rash in the treatment area led to premature withdrawal of treatment on two occasions after application of the cream and on one occasion after application of the foam. Local mild erythema and itching were the most frequent adverse events. At per-protocol analysis by ANOVA, scores for erythema, oedema, itching and local pain did not show significant differences between the two formulations, although there was a trend for itching to occur more commonly and to be more marked with the cream (p = 0.06). Additional post-hoc analysis showed a significant temporal trend only for the cream. No significant changes in safety laboratory tests were found between pre- and post-study evaluations. Conclusions: The local tolerability of the innovative foam formulation is comparable with or better than that of the reference product.
|Number of pages||8|
|Journal||Clinical Drug Investigation|
|Publication status||Published - 2002|
ASJC Scopus subject areas
- Pharmacology (medical)