A Comparative, Multicenter, Prospective, Randomized Study to Evaluate the Efficacy, Safety, and Delay of Relapse of Ceramide-Based Post-biotic Moisturizer Versus Paraffin-Based Moisturizer in Mild to Moderate Atopic Dermatitis.

BACKGROUND

Atopic dermatitis (AD) is a chronic relapsing inflammatory disease that impacts the quality of life of affected individuals as well as their families. Its pathogenesis involves impaired skin barrier function and immune dysregulation. Moisturizers are used in AD management as they help in repairing the skin barrier.

OBJECTIVE

The objective of this study was to compare the efficacy, safety, and prevention of relapse with ceramide-based post-biotic moisturizer against paraffin-based moisturizer in mild to moderate AD.

METHOD

A total of 160 AD patients were grouped into two: Group I received desonide cream 0.05% and ceramide-based post-biotic moisturizer and Group II received desonide cream 0.05% and paraffin-based moisturizer. Both groups were given treatment for four weeks. Patients who achieved complete resolution entered the maintenance phase for a maximum duration of three months. They were followed up every two weeks telephonically or as and when the patient experienced a relapse.

RESULTS

All 160 patients were completely cured and entered the maintenance phase at week 4. A total of 96/160 (71.25%) patients relapsed, with 44 relapses in Group I (55%) and 52 (65%) in Group II (p=0.25). However, in terms of mean relapse time, Group I had a 72.52±15.01 day remission period, whereas Group II had a 47.44±21.49 day remission period (p=0.0001). Moreover, Group I showed a statistically significantly prolonged estimated median time to relapse compared with Group II (median: 85 days versus 71 days, p=0.05). Both moisturizers were tolerated very well.

CONCLUSION

Although both moisturizers were effective in resolving symptoms in the treatment phase, the ceramide-based post-biotic moisturizer was more effective and statistically significant in extending the remission period against the paraffin-based moisturizer in patients with mild to moderate AD.