A study to evaluate the efficacy and safety of hydrocortisone aceponate 0.127% lipophilic cream in steroid responsive dermatoses in Indian patients.
Author(s): Mukhopadhyay AK, Baghel V
Affiliation(s): Galderma India Pvt Ltd, Andheri, Mumbai, India.
Publication date & source: 2010-09, Indian J Dermatol Venereol Leprol., 76(5):591.
Publication type: Randomized Controlled Trial
BACKGROUND: Topical corticosteroids (CSs) are the mainstay of therapy in various steroid responsive dermatoses. Newer CSs are more efficacious and safer than the older ones. There is no published data on the efficacy and safety of a new steroid hydrocortisone aceponate in the Indian population. AIM: To evaluate the efficacy and safety of hydrocortisone aceponate (0.127%) lipophilic cream in the treatment of steroid responsive dermatoses in Indian patients. METHODS: Four hundred and fifteen patients with clinically diagnosed steroid responsive dermatoses enrolled in this study. They were advised to apply hydrocortisone aceponate (0.127%) lipophilic cream as a thin film to all the affected areas twice daily. Cleansing was done prior to the application with either soap-free cleanser or soap (that would not affect the study result). Use of oral antihistamines and/or antibiotics was permissible. However, other oral/topical steroid use was not permitted during the study. Patients were evaluated at day 0 and at day 21. Data were recorded regarding clinical improvement and side-effects, if any. They were then analyzed to determine the efficacy and safety of the cream. RESULTS: Physician's global evaluation of therapy showed that lesions were cleared in 82 (22.10%), excellent result in 200 (53.91%), good result in 72 (19.41%), fair response in 15 (4.04%) and no change in 2 (0.54%) patients. There was no history of exacerbation in any patient. CONCLUSION: The study showed that hydrocortisone aceponate (0.127%) lipophilic cream is an effective therapeutic agent with a very good safety profile in various steroid responsive dermatoses in the Indian patient population.