Dermal embryofetal developmental studies were conducted in rabbits and rats with Hydrocortisone Valerate Cream, %. Hydrocortisone Valerate Cream, %, was administered topically for 4 hours/day, rather than the preferred 24 hours/day, during the period of organogenesis in rats (gestational days 5-16) and rabbits (gestational days 6-19). Topical doses of hydrocortisone valerate up to 9 mg/kg/day (54 mg/m 2 /day) were administered to rats and 5 mg/kg/day (60 mg/m 2 /day) were administered to rabbits. In the absence of maternal toxicity, a significant increase in delayed skeletal ossification in fetuses was noted at 9 mg/kg/day [ the Maximum Recommended Human Dose (MRHD) based on body surface area (BSA) comparisons] in the rat study. No malformations in the fetuses were noted at 9 mg/kg/day ( MRHD based on BSA comparisons) in the rat study. Indicators of embryofetal toxicity, significant decrease in fetal weight at 2 mg/kg/day (1X MRHD based on BSA) and a significant increase in post-implantation loss and embryo resorption at 5 mg/kg (3X MRHD based on BSA), were noted in the rabbit study. A significant increase in delayed skeletal ossification in fetuses was noted at 5 mg/kg/day (3X the MRHD based on BSA comparisons) in the rabbit study. Increased numbers of fetal malformations (., cleft palate, omphalocele and clubbed feet) were noted at 5 mg/kg/day (3X MRHD based on BSA comparisons) in the rabbit study.
Last year I developed a rash under my eyes and I was promptly prescribed hydrocortisone cream. It didn't help much and the doctor referred me to see a dermatologist. I was told to keep using the hydrocortisone and I was discharged. As the steroid cream didn't help I searched the internet for another remedy and that's how I came across a product called Magicream. It claims it only contains natural ingredients and it promised to clear up my rash. I was so excited! I have recently found out that the cream in fact contains Clobetasol Propionate and Ketoconazole. I was devastated to find this out especially since side effects include red spots and a burning sensation! When I stopped using the cream the side effects were terrible - I don't need to tell you as you know how the withdrawal of steroid can affect ones face. I then did a search on line and found your website which made so much sense and helped me to understand what was happening with my skin. I ordered the Face & Body Wash and the Face & Neck TheraCream and I have been symptom FREE ever since. Thank you from a once frustrated person!! Trish Managold, UK
Cushing's syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol propionate formulations. The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria.