Evaluation of Vasoconstriction Effects of Clascoterone Cream and Solution Versus Marketed Topical Corticosteroids in Topical Steroid Potency Classification

The primary objective of this study is to assess the **vasoconstriction** properties of two clascoterone formulations, a cream and a solution, when applied to the skin. This evaluation is conducted in comparison to three marketed topical corticosteroids. The clinical relevance of this study lies in determining the potency classification of these topical formulations, which is crucial for guiding therapeutic decisions in dermatological treatments. No secondary objectives are provided in the source data.

The clinical trial focuses on evaluating the **vasoconstriction** properties for the classification of topical steroid potency. The study population includes both male and female participants, with an age range that falls within the category code "3," which typically represents adults. The trial involves a vulnerable population, although specific details regarding the total number of participants have not been provided by the sponsor. Participants were selected based on criteria that are not explicitly detailed in the available data. Lifestyle considerations such as diet, physical activity, or habits have not been specified. The sponsor has not disclosed key inclusion or exclusion criteria for this study.

The clinical trial is designed to assess the **vasoconstriction** properties of two formulations of clascoterone, a cream and a solution, in comparison to three marketed topical corticosteroids. This study is a Phase 3, randomized, double-blind, controlled trial. The estimated recruitment start date is February 13, 2024, with an anticipated end date of May 10, 2024. The trial will involve a sequence of study visits, beginning with an inclusion visit where participants will be screened for eligibility based on specific criteria. Following the inclusion visit, participants will undergo a series of follow-up visits to monitor the effects of the formulations and ensure adherence to the study protocol. The trial will conclude with an end-of-study visit, where final assessments will be conducted to evaluate the primary and secondary endpoints.

Participants are expected to be involved in the study for the duration of the trial, from the initial screening to the end-of-study visit. The total duration of participant involvement will depend on the specific schedule of follow-up visits, which will be determined by the study protocol. Conditions that may lead to early termination from the study include non-compliance with the study protocol, adverse reactions to the study formulations, or withdrawal of consent by the participant. The trial aims to provide valuable data on the potency classification of topical steroids through the assessment of vasoconstriction properties, contributing to the understanding of the efficacy and safety of clascoterone formulations in comparison to existing corticosteroid treatments.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, or frequency of administration. As such, no detailed description of the experimental treatment can be provided based on the available data.

Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Consequently, no description of these elements can be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. Therefore, no further details can be elaborated upon in this context.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to begin recruitment on February 13, 2024, with an estimated end date of May 10, 2024. Efficacy will be evaluated using specific parameters or endpoints, although these are not detailed in the provided data. The trial will follow a structured methodology to measure, collect, and analyze these efficacy parameters, adhering to the standards expected in a Phase 3 clinical trial. The trial's design and execution will ensure that the efficacy assessments are conducted systematically and objectively, in line with clinical trial protocols.