A Randomized, Double‑Blind, Placebo‑Controlled Trial Assessing TRIV‑509 on Skin Barrier Function in Adults with Atopic Dermatitis

The primary objective is to assess the impact of TRIV-509 on skin barrier function in patients with Atopic Dermatitis. No secondary objectives are specified.

The trial enrolled both male and female individuals, comprising patients with Atopic Dermatitis and healthy volunteers, who fell within the age categories identified by codes 3 and 4. Selection of participants was based on the study’s defined inclusion and exclusion parameters, though specific criteria were not detailed in the provided information. Lifestyle factors such as diet, physical activity, and other habits were not described. The sponsor did not provide the total number of participants.

The study is a phase 3 interventional trial evaluating the effect of TRIV-509 on skin barrier function in patients with Atopic Dermatitis. The design is randomized, double‑blind and controlled, with participants allocated to either active treatment or placebo. Enrollment begins on 1 October 2025 and the trial concludes by 30 June 2026. After an initial screening visit to confirm eligibility, subjects receive the first dose and attend scheduled follow‑up visits for safety and efficacy assessments, culminating in a final end‑of‑study visit that completes the participant’s involvement. The overall study duration for each participant spans from the screening visit through the end‑of‑study visit within the defined recruitment period.