assignment
Not Recruiting

Comparative Study of Betamethasone Dipropionate and Salicylic Acid Ointments Versus Placebo in Chronic Stable Plaque Psoriasis Patients

Trial ID
2024-514788-24-00
Protocol
20-01/BetaSal-S

Trial statistics

location_city
13
research sites
public
1
country
medical_information
1
disease
person_search
13
investigators

Diseases & Conditions

Objectives

The primary objective of this clinical study is to evaluate the **therapeutic effects** of two ointments containing active substances, **betamethasone dipropionate** and **salicylic acid**, compared to an ointment without active substances in patients with **chronic stable plaque psoriasis**. This evaluation is clinically relevant as it aims to determine the efficacy of these active substances in managing the symptoms and progression of this common dermatological condition, potentially leading to improved treatment protocols and patient outcomes.

Participants

The clinical trial involves participants diagnosed with **chronic stable plaque psoriasis**. The study population includes both male and female subjects, with an age range spanning from 18 to 65 years. The trial population was selected to include a vulnerable population, although specific details regarding the total number of participants have not been provided by the sponsor. Participants' general health status, lifestyle considerations such as diet, physical activity, or habits, and specific inclusion or exclusion criteria are not detailed in the available data.

Plans and Procedures

The clinical trial is designed to evaluate the therapeutic effects of two ointments containing **betamethasone dipropionate** and **salicylic acid**, compared to an ointment without active substances, in patients with **chronic stable plaque psoriasis**. The study follows a randomized, double-blind, controlled design to ensure unbiased results and reliable data. The trial is expected to span from October 7, 2022, to October 31, 2025, providing a comprehensive assessment of the treatment's efficacy over an extended period.

Participants will undergo a series of study visits, beginning with an inclusion visit, which serves as a screening to confirm eligibility based on predefined criteria. Following successful inclusion, participants will attend regular follow-up visits to monitor their response to the treatment and any potential side effects. These visits are crucial for collecting data on the primary and secondary endpoints of the study. The trial will conclude with an end-of-study visit, where final assessments will be conducted to evaluate the overall outcomes of the treatment.

The expected duration of participant involvement in the study is approximately three years, aligning with the overall trial timeline. However, certain conditions may necessitate early termination from the study, such as adverse reactions to the treatment, non-compliance with study protocols, or withdrawal of consent by the participant. The study is conducted in accordance with ethical guidelines and regulatory requirements to ensure the safety and well-being of all participants throughout the trial.

Treatment

In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the **experimental medication**, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, is not available.

Due to the absence of specific details, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be included. The data does not contain any information about the **disease** being studied, the trial's main objective, or any other pertinent details that would typically be included in a clinical trial description.

Efficacy

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized under phase 5, indicating a focus on post-marketing surveillance to gather additional information on the drug's effectiveness and safety. The estimated recruitment start date is October 7, 2022, with an anticipated end date of October 31, 2025. Although specific efficacy parameters such as primary or secondary endpoints are not detailed, the trial will likely involve systematic data collection and analysis to evaluate the treatment's impact on the targeted medical condition. The trial's design will adhere to rigorous scientific standards to ensure the reliability and validity of the efficacy assessments.

Trial Status by Country

Country Status Start of Recruitment Planned Patients
Germany GermanyNot Recruiting07 Oct 2022306

Sites & Investigators

Conditions Studied in This Trial