Laboratory and clinical evaluation of a new formulation of 8-methoxypsoralen in the treatment of vitiligo

ABSTRACT

A new formulation of 8-methoxypsoralen [8-MOP] capsule was investigated both in the laboratory and clinically. Laboratory investigations showed that the new formulation is absorbed better than the currently available 8-MOP and it reaches a peak blood level in 45 minutes. Clinically, 14 vitiligo patients received the new drug in a dose ranging from 0.25-0.4 mg/kg body weight and exposed their vitiliginous patches to the sun at midday [45 minutes after drug ingestion]. An excellent response [>75% of a test patch repigmented] was obtained in 5 patients [35.7%], a good response [50-75% of the patch covered] was obtained in 3 patients [21.4%] and an unsatisfactory response [<50% of the patch covered] was obtained in 6 patients [42.9%]. Side effects were very minimal. The new formulation of 8-MOP capsule is safe, more effects than the marketed tablet formulation and its dose can be raised in nonresponding cases without producing nausea or vomiting