Overview on desonide 0.05%: a clinical safety profile

Journal of Drugs in Dermatology, July-August, 2004 by Vicky Kwan Wong, Brian Fuchs, Mark Lebwohl

Exacerbation of Disease/Lack of Effect

Reports of exacerbation of the disease, frequently described as worsening of redness, were made on five occasions, four by physicians. Where given, the time to onset was generally within the first two weeks of desonide use. In addition, there were eight (12.9%) reports by consumers of lack of efficacy but very little detail is available. None of these were verified by a healthcare professional.

Other Adverse Effects

Eight adverse events identified by the pharmacovigilance program could not be categorized (Table II) of which one (in a six-month-old) has been described under serious reactions. Five of these reports came from consumers, and included such diverse complaints as scars on face, bleaching around the treatment area, cataract, tingling feet, and sleeping difficulty. In addition, there was a published report of topical corticosteroid-induced acne following treatment of a two-year-old girl with clotrimazole 1%, betamethasone cream 0.05%, and desonide cream 0.05% (4). Finally, hypochromia was reported by a physician in another two-year-old child but no further details are available.

Comparison of Desonide with Hydrocortisone--A Review of Published Trials

Further support for the safety profile of desonide comes from the literature on randomized, controlled clinical trials in which the mild corticosteroid hydrocortisone has been used as comparator.

Studies in Children

The safety and efficacy of desonide ointment 0.05% with 1.0% hydrocortisone was compared in 113 children (mean age: 4.8 years) with mild to moderate atopic dermatitis (3). In this multi-center, parallel group study, treatments were applied twice daily for five weeks (extended to six months in 36 patients); response to treatment was assessed at weeks 1, 3 and 5, and at months 2 to 6.

Fifty-seven patients were randomized to receive desonide and 56 to receive hydrocortisone; the majority of patients (90, or 79.6%) completed five weeks of treatment and 111 were assessable for efficacy. The response to treatment is reflected in the primary efficacy variable, the physician's overall global assessment of improvement, which is shown in Figure 1. By week one, there was a significant difference in the percentage of patients with cleared or marked improvement (P=0.05, chi-square test). Patients in both treatment groups continued to improve during the study; at the last observation made, the difference between the two groups was highly significant (69% desonide vs. 41% hydrocortisone; P=0.003).

[FIGURE 1 OMITTED]

No differences in safety were observed between desonide and hydrocortisone; neither treatment produced signs of atrophy even at the six-month evaluation, and any stinging or burning sensation reported was slight. The authors concluded that desonide 0.05% ointment showed greater efficacy but an equivalent safety profile when compared with hydrocortisone 1% for up to six months.

Lucky, et al (6) studied systemic safety, by comparing the effects of desonide ointment 0.05% with hydrocortisone 2.5% on the HPA axis of children (aged 11 months to 11 years) with a minimum of 20% of their body surface affected by atopic dermatitis. In this open-label, parallel group study, ointment was applied twice daily over a four-week period (approximately 3-g of ointment per day). Early morning serum cortisol levels were determined at baseline and on days 14 and 28, with adrenocorticotropic hormone (ACTH) stimulation of cortisol production being measured on days 0 and 28.