The moisturizer used was Bia Eczema Relief Lotion (Codex Labs, San Jose, CA). It contains: 1% colloidal oatmeal, aqua, Helianthus annuus seed oil, propanediol, glyceryl stearate, glycerin, Lactobacillus ferment, C13-15 alkane, cetyl alcohol, Calendula officinalis meristem cell extract, Haberlea rhodopensis leaf cell extract, Padina pavonica thallus extract, Symphytum officinale leaf extract, Cocos nucifera fruit extract, Butyrospermum parkii (shea) butter, Moringa oleifera seed oil, Limnanthes alba seed oil, Macadamia integrifolia seed oil, Cedrus deodara wood oil, hydrogenated lecithin, phytosphingosine, hydrolyzed sodium hyaluronate, ceramide NP, sodium phytate, sclerotium gum, xanthan gum, sodium benzoate, potassium sorbate, citric acid.

The soap used was Bia Unscented Soap (Codex Labs, San Jose, CA) and it contains: sodium olivate, sodium cocoate, sodium shea butterate, aqua, Daucus carota sativa root extract, sodium castorate, sodium sunflowerate, sodium cocoa butterate, Calendula officinalis.

Subjects were instructed to use the soap up to twice daily while bathing, and the moisturizer as needed. All investigational products were stored securely at room temperature.

Test strain suspensions were freshly prepared from the log phase. A co-culture of the test microorganisms was prepared in a 1:10 ratio. For the test preparation, a master mix 75% ml PBS, 5% Tryptic soy (CASO) broth and 10% of the respective microbe suspension were mixed with 500 µl of the product.

Incubation took place under shaking 4 h (‘leave on’ products) at 32°C ± 2°C. Samples were plated and bacterial counts are determined in triplicates at time points t = 0 and t = 4 h, respectively. The CFU/ml and the ratios between product and control were then calculated.

Eligible participants were healthy male and female subjects, aged 18 years and older, with Fitzpatrick I to IV phototypes. Participants had active AD with a scoring atopic dermatitis (SCORAD) score between 25 and 50. Subjects were required to maintain their hygiene and makeup habits throughout the study. Exclusion criteria included pregnant or nursing women, and use of antibiotics or antifungal treatments to their body or scalp one month prior to enrollment.

This eight-week, open-label clinical trial took place between March and September 2024 in Malbork, Poland. It was conducted by EUROFINS Dermscan/Pharmascan (Gdańsk, Poland) in compliance with the Declaration of Helsinki (1964) and its subsequent amendments. The Internal Bioethics Committee at Dermscan Poland approved the protocol. Data collection followed the study protocol, current internal procedures, and Good Clinical Practice (GCP) guidelines (CPMP/ICH/135/95 [R2]. Written informed consent was obtained from all participants prior to enrollment. The study was registered retroactively on clinicaltrials.gov with identifier NCT06804070.

Participants meeting all criteria were enrolled in the study. Prior to the baseline (D0), all enrolled subjects completed a wash-out period, using the unscented soap twice daily for 2–3 days. Each participant acted as their own control throughout the study. During the study, participants were instructed to use the soap on the entire body twice daily (morning and evening) in replacement of their usual cleansing product. Subjects were instructed to use the moisturizer on the body, especially on active lesions of AD at least twice daily and as often as needed. However, for each subject, 1 area of the body with no active AD lesion, as selected by a dermatologist, was spared from moisturizer application. No modifications were made to the methods or trial outcomes after the study began, and it concluded once all participants completed the required visits. Study visits were scheduled at a standard interval (SI) screening, baseline (D0), week 4 (D28), and week 8 (D56).

SCORAD scores were assessed at D0 and D56, using a three-step process to evaluate the extent score (A), intensity score (B) and the pruritus/insomnia score (C). The total SCORAD score was calculated using the formula: A/5 + 7B/2 + C. The objective SCORAD (oSCORAD) score, which excludes the subjective components, was calculated using the formula: A/5 + 7B/2.

Additional measures of pruritus improvement assessed at D56 included the number of subjects achieving a 4-point reduction in the NRS the proportion of subjects with an NRS of 0 or 1, and the proportion of subjects reporting an NRS of 0. The third method was a global assessment of pruritus, where subjects rated their pruritus severity on a scale of 0=no, 1=mild, 2=moderate, and 3=severe pruritus at the SI.

All biophysical measurements were taken after subjects had a 15-minute period to acclimate to ambient conditions in a climate-controlled room.¹⁹ Measurements were collected at SI on predetermined skin areas, including one treated area with an active lesion and one non-treated area without a lesion. The following biophysical properties were assessed: trans-epidermal water loss (TEWL) using a Tewameter® (Courage + Khazaka, Köln, Germany), skin hydration using a Corneometer® (Courage + Khazaka, Köln, Germany), and squamae surface area (SSS) in mm² and desquamation index (DI) using D-Squame® (Clinical and Derm LLC, Dallas, TX, USA).

PANAS is a validated patient-oriented questionnaire that measures positive and negative effects.²⁰ Participants were asked to evaluate the degree to which they experienced effective components over the past week: Interested, Distressed, Excited, Upset, Strong, Guilty, Scared, Hostile, Enthusiastic, Proud, Irritable, Alert, Ashamed, Inspired, Nervous, Determined, Attentive, Jittery, Active, and Afraid. A 5-point scale was used for responses, ranging from 1 (very slightly or not at all) to 5 (extremely).

Two macrophotographs of selected areas were taken using a Nikon D90 camera at D0, D28, and D56. One selected area was a treated area with an AD active lesion (hand or arm or around the elbow), and the other selected area was a non-treated area without an AD lesion.

Differences in SCORAD scores, pruritus responses, TEWL, hydration, SSS, and DI were analyzed using a paired Student t-test for parametric measures. Non-parametric data were evaluated using the Wilcoxon rank-sum analysis. A p-value < 0.05 was deemed statistically significant. All comparisons were made within groups, with baseline data serving as the control.

Incubation with the moisturizer in the ex vivo assay showed that the moisturizer promoted an increased ratio of S. epidermidis to S. aureus by 1.5-fold (Figure 1).

Figure 1.

Of the 34 participants enrolled, 71% were female (n=24) and 29% were male (n=10). The mean age of participants was 32 years (range, 22-52). Of all participants, 26% (n=9) and 74% (n=25) had Fitzpatrick skin types I and II, respectively. The average total SCORAD at D0 was 29.8 (range, 25-46). The flow of participants throughout the study is shown in Figure 2. Thirty-three subjects completed the entire study.

Figure 2.

Total and objective SCORAD scores were evaluated at D0 and D56. The mean total SCORAD scores were 29.8 and 1.7, representing a 99% reduction (p < 0.0001, Figure 3A). The mean oSCORAD scores were 23.1 and 1.4, representing a 94% reduction (p < 0.0001, Figure 3B). At D56, 91%, 88%, 85%, and 85% of participants achieved oSCORAD50 (50% reduction in oSCORAD compared to D0), oSCORAD75, oSCORAD90, and oSCORAD100, respectively (Figure 3C).

Figure 3.

The mean pruritus NRS reduced from 4.2 to 0.3 (p < 0.0001) between D0 and D56 (Figure3A). The proportion of subjects at D56 that achieved a 4-point reduction in their NRS was 91%, an NRS of 0 or 1 was 94%, and an NRS of 0 was 79% (Figure 4B). The subject global assessment of pruritus revealed a significant reduction (p < 0.0001) at both D28 and D56 (Figure 4C).

Figure 4.

There were no significant changes seen in the overall or component positive affect scores. However, the overall negative affect score decreased at D56 (p < 0.07, Figure 6A), and significant improvements were observed in two negative affect components (Figure 6B). More specifically, there was a significant decrease in distress (p < 0.008) and upset (p = 0.046).

Figure 6.

Photographs of active AD sites treated with the moisturizer and soap are shown in Figures 7 and 8.

Figure 7.

Figure 8.

During the study, 5 participants experienced an adverse event. Adverse events included throat infection, three headaches, and a toothache. Each event was self-limiting and not deemed to be related to the studied products. None of these adverse events led to an interruption in study protocol or withdrawal.

JM reports serving as a consultant for Codex Labs (stockholder). PAL reports being on the speaker’s bureau for AbbVie, Arcutis, Eli Lilly, Galderma, Hyphens Pharma, Incyte, La Roche-Posay/L’Oréal, Pfizer, Pierre-Fabre Dermatologie, Regeneron/Sanofi Genzyme, Verrica; reports consulting/advisory boards for Alphyn Biologics (stock options), AbbVie, Almirall, Amyris, Arcutis, ASLAN, Bristol-Myers Squibb, Burt’s Bees, Castle Biosciences, Codex Labs (stock options), Concerto Biosci (stock options), Dermavant, Eli Lilly, Galderma, Janssen, LEO Pharma, Lipidor, L’Oréal, Merck, Micreos, MyOR Diagnostics, Regeneron/Sanofi Genzyme, Sibel Health, Skinfix, Suneco Technologies (stock options), Soteri Skin (stock options), Theraplex, UCB, Unilever, Verdant Scientific (stock options), Verrica, Yobee Care (stock options). In addition, Dr. Lio has a patent pending for a Theraplex product with royalties paid and is a Board member and Scientific Advisory Committee Member emeritus of the National Eczema Association. RKS reports serving as an advisor for LearnHealth, Arbonne, and Codex Labs, and Trace Minerals and has served as a consultant or speaker for Burt’s Bees, Novozymes, Almirall, Novartis, Incyte, Lilly, Sanofi, Bristol Myers Squibb, Pfizer, Nutrafol, Galderma, Abbvie, Leo, UCB, Sun, and Regeneron Pharmaceuticals.