Cream vehicle
Clocortolone pivalate 0.1% is formulated in a cream that contains three ingredients which assist in stratum corneum permeability barrier integrity: white petrolatum (occlusive), mineral oil (humectant), and stearyl alcohol (long-chain fatty alcohol emollient). This cream does not contain lanolin, fragrance, nor propylene glycol, all of which have been known to be problematic for some patients. Clinical studies
In Phase III trials, Cloderm was found to be especially useful in treating eczema, atopic dermatitis, and psoriasis. Phase III trials also showed rapid action and relief for the majority of the patients involved. There is no age restriction on the use of clocortolone pivalate 0.1% cream. Clinical trials comparing clocortolone pivalate 0.1% topical cream with vehicle in atopic dermatitis/eczematous dermatitis, psoriasis, and contact dermatitis included pediatric patients (N=44). The mean age of pediatric subjects was 10 years (range 3–14 years). Clocortolone pivalate 0.1% cream was efficacious for the majority (75%) of the pediatric patients in these trials, with no serious adverse effects occurring in either group.In six parallel, double-blind, placebo-controlled trials, patients with atopic dermatitis/eczematous dermatitis were randomized to treatment with clocortolone pivalate 0.1% topical cream (total n=109) or vehicle (total n=100), applied three times daily over a duration of 14 days.
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.