According to evaluations completed by the physician investigators, a significantly higher proportion of patients in the clocortolone pivalate group than patients in the vehicle group demonstrated a good or excellent response at Days 4, 7, and 14.Due to the chronic and lengthy nature of some steroid responsive dermatoses such as atopic dermatitis and psoriasis, a study of 27 patients was conducted, wherein these patients were treated with Cloderm from 30 days up to 7 months. The results of these treatments showed a low rate of adverse reactions and no signs of striae, atrophy, or hypopigmentation. Adverse reactions that were experienced included burning, itching, irritation, dryness, and/or folliculitis.Additionally, a clinical study investigated the potential of hypothalamic–pituitary–adrenal (HPA) axis suppression. Ten men with no major health issues applied 30g of clocortolone pivalate 0.1% cream twice a day for 21 days while wearing a plastic sweat suit for twelve hours per day. Through the measurements of plasma cortisol and urinary 17-ketosteroid levels, the investigators monitored effects on the HPA axis, and no signs of adrenal suppression were evident.In total to date, 559 patients have participated in clinical trials involving Cloderm, and there was little evidence of local and/or systemic adverse effects. Specifically, only 4.4 percent experienced adverse events, most of which were local application-site reactions, such as dryness, stinging, burning, or itching. Regulation history
Cloderm, the brand formulation of clocortolone pivalate 0.1% cream, was approved by the
Food and Drug Administration in 1977 for the treatment of corticoid responsive dermatoses.
Clocortolone (Cloderm) is a topical steroid. It is used in the form of an ester, clocortolone pivalate, and applied as a cream. It is used for the treatment of dermatitis and is considered a medium-strength corticosteroid. It is unusual among steroids in that it contains a chlorine atom and a fluorine atom. Pharmacology
Clocortolone is an upper-mid potency topical corticosteroid formulation. It is rated at a class 4 potency on a scale of 1 (highest potency) to 7 (lowest potency). Most patients are treated with mid-potency topical corticosteroids, for they are an effective medium between safety and efficacy for short and long-term conditions. Vital to the pharmacological action of clocortolone is the presence and location of its functional groups. There were several molecular modifications done to create clocortolone pivalate, including beta-hydroxylation at C-11, methylation at C-16, double bonds at C-12, esterification at C-21, and halogenation at C-6 and C-9. It is common in the medical community to associate halogenation of topical corticosteroids with adverse effects. This notion is, in fact, incorrect—it is both the presence and location of halogenation in steroids that matter. In comparison to all other topical corticosteroids, the combination of the chlorine at C-9 and the fluorine at C-6 is unique to clocortolone. Clocortolone pivalate, due to its unique nature, has both upper-mid potency and the safety profile associated with a lower potency topical corticosteroid. This versatility allows for Cloderm cream to be a treatment option for a variety of patients.