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A randomized, double-blind, placebo-controlled study to evaluate the efficacy in AD of liquid soap containing 12%
1Department of Dermatology, Sheba Medical Center, Tel. Hashomer, Israel. boazam@clalit.org.il
Insights
A new liquid soap with ammonium lactate and urea effectively treated atopic dermatitis (AD) symptoms like dryness and scaling in a 3-week study. This topical treatment improved skin condition for patients with mild to moderate AD.
Area of Science:
- Dermatology
- Clinical Research
- Dermatological Therapeutics
Background:
- Atopic dermatitis (AD) is a prevalent chronic inflammatory skin condition, frequently impacting children.
- Xerosis (dry skin) is a particularly distressing symptom for individuals with AD.
- Current management strategies for AD often involve topical treatments to alleviate symptoms.
Purpose of the Study:
- To assess the therapeutic efficacy of a novel liquid soap formulation containing 12% ammonium lactate and 20% urea.
- To evaluate the impact of this specialized soap on key clinical indicators of atopic dermatitis.
- To compare the effectiveness of the active soap against a placebo in patients with mild to moderate AD.
Main Methods:
- A randomized, double-blind, placebo-controlled study involving 36 participants (aged 3-40) with mild to moderate AD.
- Participants were randomized into active treatment (2:1 ratio) and placebo groups for daily soap use over three weeks.
- Efficacy was evaluated through clinician assessments and patient-reported outcomes, focusing on scaling, dryness, redness, and itch.
Main Results:
- Significant improvements were observed in scaling (P < 0.0001) and skin dryness (P < 0.0001) in the active treatment group compared to placebo.
- Investigator-rated redness also showed significant improvement (P = 0.03).
- Patient-reported itch significantly decreased (P < 0.001) in the group using the ammonium lactate and urea soap.
Conclusions:
- The liquid soap containing 12% ammonium lactate and 20% urea demonstrated significant efficacy in managing symptoms of atopic dermatitis.
- The formulation proved effective in improving objective measures of skin condition and subjective patient-reported itch.
- This specialized soap represents a potentially beneficial therapeutic option for patients with stable, mild to moderate atopic dermatitis.
Abstract:
Atopic dermatitis (AD) is a common chronic skin disease, which mainly affects children. Xerosis is one of the most troublesome signs of the disease. The aim of this study was to evaluate the efficacy of liquid soap containing 12% ammonium lactate + 20% urea in patients with AD. In a randomized, double-blind study, 36 patients (both male and female patients; age range 3-40 years) with mild to moderate AD were enrolled. Patients were divided randomly into two groups, in a ratio of 2:1 (active:placebo). The prescribed soap was used on a daily basis during a shower for 3 weeks. All patients continued all other systemic or topical medication but avoided any other soap or emollients. After 3 weeks of treatment, efficacy was assessed both by clinician and patient. There were significant improvements in scaling (P < 0.0001), skin dryness (P < 0.0001) and redness (P = 0.03) as rated by the investigator, and subjective patient assessment of itch also improved (P < 0.001) in the study group compared with the control group. The liquid soap was found to be effective in patients with AD, as use of this soap in patients with stable mild to moderate AD improved the parameters studied.
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