Evaluation of Urea/Propylene Glycol Creams for Maintenance Therapy in Atopic Dermatitis: A Controlled, Split-Body Study

The primary objective is to demonstrate superiority in time to relapse of eczema with the two moisturising creams (Oviderm and Urea/propylene glycol) compared with no treatment, establishing clinical benefit for maintenance therapy of Atopic Dermatitis. Secondary objectives address additional efficacy and safety endpoints:

• Comparison of time to relapse between Oviderm and the Urea/propylene glycol cream.
• Evaluation of pruritus reduction with each cream versus no treatment.
• Evaluation of pruritus reduction when Oviderm is compared directly with the Urea/propylene glycol cream.
• Assessment of safety parameters for both moisturisers.

The trial enrolled adult participants (≥ 18 years) of both sexes who had a confirmed diagnosis of Atopic Dermatitis meeting moderate to severe disease criteria (IGA ≥ 3, mEASI ≥ 4) with appropriate lesions on the arms or legs. Enrollment required written informed consent and assessment of lesion size and distribution according to protocol specifications, and participants were required to be able to achieve complete clearance with a class III corticosteroid regimen for approximately four weeks. The sponsor did not provide the total number of participants.

The study is a prospective, controlled, split‑body trial evaluating two moisturising creams in adults with moderate to severe atopic dermatitis. After written informed consent, participants attend a screening visit to confirm eligibility, document baseline lesion characteristics, and receive a short course of class III topical corticosteroid to achieve clearance. At the baseline visit, each participant’s defined lesions on the left and right upper or lower extremities are assigned to one of three conditions: test cream (Urea/propylene glycol 50 mg/g + 250 mg/g), comparator cream (Oviderm 250 mg/g), or no treatment, with the allocation documented but not blinded. Participants apply the assigned product(s) daily and are followed with regular study visits (typically every 2–4 weeks) to record time to eczema relapse, pruritus scores, and adverse events. The maintenance phase continues until the first documented relapse on any study area or until the scheduled end‑of‑study visit, whichever occurs first. The overall trial recruitment period spans from November 2025 to September 2026, and individual involvement may extend up to several months depending on relapse timing. Early termination may occur if a relapse is observed before the planned end of follow‑up, if a serious adverse event arises, or if the participant withdraws consent.

The investigational product, identified as Urea/propylene glycol 50 mg/g + 250 mg/g cream, is a topical cream formulated with propylene glycol and urea. It is intended for cutaneous use and is supplied in a cream base containing a total of 600 mg/g of active substances. Application is instructed per protocol, with the dosage defined by the amount applied to the affected skin area; the administration route is topical.

The comparator moisturizer, Oviderm 250 mg/g kräm, is a commercially available emollient classified under ATC code D02AX (other emollients and protectives). This cream contains propylene glycol as the sole active ingredient at a concentration of 500 mg/g and is also applied cutaneously in accordance with the study schedule.

In addition to the two moisturising creams, the study includes a non‑treatment condition serving as a control for relapse timing. Participant adherence to the assigned regimen, whether active product or no treatment, is documented throughout the trial in accordance with the protocol‑defined compliance monitoring procedures.

The study evaluates efficacy in participants with Atopic Dermatitis by measuring the Time to relapse of eczema as a patient‑reported outcome (PRO) on a predefined study area. The interval from baseline to either documented relapse or the end of the maintenance phase, whichever occurs first, constitutes the primary efficacy assessment.

Secondary efficacy assessments include the change in self‑reported pruritus on the same study area from baseline to relapse or study end, quantified using the Peak Pruritus Numerical Rating Scale (NRS). Pruritus changes are evaluated both as an overall change and at each scheduled evaluation point throughout the maintenance phase. All efficacy parameters are collected prospectively, and analyses will compare the investigational cream, the comparator cream, and the untreated control within the split‑body design.