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

Atopic dermatitis (AD) is a chronic inflammatory skin condition marked by itching, erythema, and recurrent flare-ups that impact quality of life significantly. Traditional treatments like topical corticosteroids and emollients provide symptomatic relief, but long-term control and relapse prevention remain a challenge. With emerging interest in skin microbiota and the role of commensal microbes, post-biotics—non-viable microbial derivatives with immunomodulatory potential—have gained attention as novel therapeutic agents. Ceramide-based post-biotic moisturizers combine skin barrier repair with microbiome-friendly benefits, offering a promising alternative to conventional paraffin-based moisturizers. This study evaluates their comparative efficacy, safety, and ability to delay relapse in patients with mild to moderate AD.


Methods

This multicenter, prospective, randomized clinical study included 160 patients with mild to moderate AD, divided into two groups. Group I received desonide cream and a ceramide-based post-biotic moisturizer, while Group II received desonide cream and a paraffin-based moisturizer. After a 4-week treatment phase, patients who achieved symptom resolution entered a 3-month maintenance phase using moisturizers alone. Patients were followed every two weeks or at relapse to evaluate symptom recurrence, using validated scoring systems including IGA, EASI, VAS, and DLQI.


Key Findings

  • Symptom Resolution: All 160 patients achieved complete resolution by the end of week 4.
  • Relapse Rates:
    • Group I (ceramide-based post-biotic): 55% relapsed
    • Group II (paraffin-based): 65% relapsed
  • Remission Duration:
    • Mean time to relapse was significantly longer in Group I (72.5 ± 15.0 days) than Group II (47.4 ± 21.5 days); p = 0.0001
    • Median time to relapse: Group I – 85 days vs. Group II – 71 days; p = 0.05
  • Skin Improvement Metrics:
    • Comparable reductions in IGA, EASI, VAS, and DLQI scores were observed across both groups during the treatment phase.
  • Safety: Only two mild cases of dryness were reported in Group I, with no severe adverse events in either group.

This study highlights the superior performance of a ceramide-based post-biotic moisturizer over a traditional paraffin-based option in prolonging remission and delaying relapse in atopic dermatitis. The novelty lies in combining ceramides with post-biotic ingredients—offering both barrier-repair and microbiome-modulating benefits. As an emerging class of skincare agents, post-biotic formulations may redefine long-term AD management. Further large-scale trials and mechanistic studies are needed to optimize formulations and validate efficacy across broader patient populations.

Link to the study: https://tinyurl.com/23ph9zdb