my personal edition > dermatitis > news


  E-Mail this DGDispatch to a colleague

DGDispatch

Successful Use of Nonsteroidal Cream to Treat Mild to Moderate Atopic Dermatitis in Infants and Children: Presented at EADV

By Chris Berrie

VIENNA, AUSTRIA -- May 25, 2007 -- The nonsteroidal cream MAS063DP (AtopiclairŪ) is an effective and well-tolerated monotherapy for infants and children with mild to moderate chronic atopic dermatitis (AD), according to a multicentre, randomised, double-blind, vehicle-controlled trial.

The study was presented here on May 18^th at the 16^th European Academy of Dermatology and Venereology Congress (EADV).

This nonsteroidal cream contains a number of key agents: glycyrrhetinic acid contributes antipruritic and anti-inflammatory properties; hyaluronic acid is a powerful moisturising agent; shea butter protects and softens the skin; telmesteine, Vitis vinifera, and vitamins C and E have antioxidant properties.

While MAS063DP has been shown to be efficacious and safe in adults with AD, researchers led by Mark Boguniewicz, MD, specialist in allergic and immunological diseases, paediatrics department, National Jewish Medical and Research Centre, Denver, Colorado, United States, aimed to assess the possibility of extending this to infants and children.

In total, 142 infants and children ranging in age from 6 months to 12.5 years (male, 48%) were randomised to vehicle (n = 70) or MAS063DP (n = 72). The vehicle treatment was with an emollient-based cream similar to MAS063DP but without the key ingredients of MAS063DP.

The creams were applied to the affected areas 3 times daily for 43 consecutive days. Prior therapies were discontinued 7 to 14 days before the start of study treatment; phototherapy was not allowed for the duration of the trial.

Efficacy measures were assessed on days 3, 8, 15, 22, 29, and 43, and were based on Investigators' Global Assessment (IGA), patients' or their caregivers' assessment of itching with the Visual Analogue Scale (VAS), Eczema Area and Severity Index (EASI) score, presence or absence of clinical signs of AD, need for rescue medication, patients' or caregivers' assessment of global response, and their appraisal of the study medication. Adverse events were also assessed and recorded.

The primary efficacy endpoint was IGA score at day 22.

Baseline patient demographics and disease characteristics were similar across the vehicle and MAS063DP groups.

At day 22, IGA score showed significantly better 77% treatment success with MAS063DP, with 41% of patients being clear of AD and 36% almost clear (P <.0001). Of note, significantly better responses were seen for MAS063DP throughout the study, with its 22-day positive response maintained to the end of the study.

Similarly, significantly more reduced VAS scores were seen with MAS063DP compared with vehicle from day 3 to 43 in terms of itch relief. EASI score also improved rapidly with MAS063DP, with significantly greater mean score changes > 5 seen by day 22, compared with the slight EASI score deterioration seen with the vehicle (P <.0001).

Use of vehicle showed slight deterioration versus substantial improvement with MAS063DP by day 43 in clinical signs of AD (P <.0041), good improvement reported by 10% versus 81% of patients/ caregivers (P <.0001), plus other significant effects, including increased duration of itching relief, willingness to continue on medication, and ease of use and cosmetic acceptability.

The total of 116 adverse effects seen were evenly distributed across the 2 treatment groups and were all classified as mild or moderate, with most considered unrelated to the study treatment. The most frequently reported were burning (vehicle, 7.1%; MAS063DP, 6.9%), upper respiratory infection (8.6% vs 5.6%), stinging (2.8% vs 8.3%), and the common cold (7.1% vs 2.8%).

The researchers concluded that MAS063DP cream is an effective and well-tolerated nonsteroidal monotherapy for infants and children with AD. They also emphasised the early effects seen and the potential for this MAS063DP cream as a steroid-sparing agent, an important consideration for this particular patient population.


[Presentation title: Successful Use of MAS063DP (AtopiclairŪ) to Treat Mild to Moderate Atopic Dermatitis in Infants and Children: Results of a Multicentre, Randomised, Controlled Trial. Abstract P50]

E-Mail this DGDispatch to a colleague

To print, use this version