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Retinoid

A Companion Treatment Study for Patients With Moderate to Severe Acne Vulgaris

Phase 4

Waitlist Available

Led By Edward Lain, MD, MBA

Research Sponsored by Edward Lain, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 44 weeks

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests the combined use of a topical foam (AMZEEQ®) and an oral medication (isotretinoin) for treating acne. It targets people with persistent acne to see if using both treatments together is more effective than using just the oral medication. The foam reduces bacteria and inflammation on the skin, while the oral medication reduces oil production and prevents clogged pores. Isotretinoin is a first-generation synthetic retinoid used for severe acne, known for its effectiveness but also for significant side effects.

Eligible Conditions

Acne
Acne Vulgaris

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 44 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~44 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 44 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

IGA Improvement

Lesion Improvement

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment Group BExperimental Treatment2 Interventions

Patients will receive once daily treatment of oral isotretinoin for 20 weeks, followed by a further 24 weeks of once daily AMZEEQ® only treatment.

Group II: Treatment Group AExperimental Treatment2 Interventions

Patients will concomitantly receive once daily treatment of oral isotretinoin and topical AMZEEQ® for 20 weeks, followed by a further 24 weeks of once daily AMZEEQ® only treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Isotretinoin

2019

Completed Phase 4

~3520

Amzeeq 4% Topical Foam

2021

Completed Phase 4

~40