Subjects with Target Lesion Parameter Clear at Endpoint
n (%) BMV lotion
n (%) Placebo foam
n (%) Scaling 30 (47%) 22 (35%) 2 (6%) Erythema 26 (41%) 16 (25%) 2 (6%) Plaque Thickness 42 (66%) 25 (40%) 5 (16%) Investigator's Global: Subjects Completely Clear or Almost Clear at Endpoint 43 (67%) 29 (46%) 6 (19%)
Giant cell arteritis is a condition which causes inflammation on the inside of some arteries (blood vessels). It is called 'giant cell' because abnormal large cells develop in the wall of the inflamed arteries. The arteries commonly affected are those around the head and neck area. The artery most commonly affected is the temporal artery. (You have a temporal artery on each side of the head). They are under the skin to the sides of the forehead - the temple area.) Therefore, the condition is sometimes called 'temporal arteritis'. If left untreated it can cause serious sight loss.
The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids, which is similar in pediatric and adult populations. Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome (patients > 2 years of age), and aggressive lymphomas and leukemias (patients > 1 month of age). Other indications for pediatric use of corticos-teroids, e. g. , severe asthma and wheezing , are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations.