RecruitingPhase 2ACTRN12624000746538

A Phase 2, Proof-of-concept, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AT-5214 in Subjects with Moderate to Severe Facial Acne Vulgaris

Sponsor

Atacama Therapeutics Australia, Pty Ltd.

Enrollment

100 participants

Start Date

Nov 13, 2024

Study Type

Interventional

Conditions

Acne vulgaris

Summary

This phase 2 study is a randomized, placebo-controlled, double-blind trial of an oral drug called AT-5214 vs placebo in participants with moderate to severe facial acne vulgaris. The study will assess the efficacy and safety of AT-5214.

Eligibility

Sex: Both males and femalesMin Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a new oral medication called AT-5214 for people with moderate to severe facial acne. Acne is one of the most common skin conditions, and while many treatments exist, some people still struggle to find something that works. AT-5214 is taken as a pill, and researchers want to find out whether it reduces acne compared to a placebo (a dummy pill with no active ingredient). The trial is randomised and double-blind, meaning neither you nor the research team will know which treatment you are receiving during the study. This helps ensure the results are fair and unbiased. The study will measure how much your acne improves and check that the medication is safe to use. You may be eligible if you are 16 years or older, have oily skin and moderate to severe facial acne, and are a non-smoker. You must also be willing to use contraception if there is any chance you could become pregnant, and agree to keep your usual skincare routine the same throughout the study.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

This is a multi centre, double-blind, randomized, placebo-controlled proof-of-concept trial to evaluate the efficacy and safety of AT-5214 in participants with moderate to severe acne vulgaris. App

This is a multi centre, double-blind, randomized, placebo-controlled proof-of-concept trial to evaluate the efficacy and safety of AT-5214 in participants with moderate to severe acne vulgaris. Approximately 100 participants will be randomized in a 1:1 ratio to receive either AT-5214 oral tablet or an identical placebo oral tablet. Eligible participants who withdraw before the start of treatment will be replaced. Participants will receive oral AT-5214 or placebo tablets, 4 mg twice daily (BID) for 12 weeks. Participants will be provided with a diary card which they will be trained to use to record daily administration of the study drug. Compliance with the study treatment will be measured by return of unused drugs at the end of the treatment period (12 weeks).