← Back to Search

Retinoid

Isotretinoin for Acne

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

Study Summary

This trial is studying the effects of a new acne drug, AMZEEQ, when used with the existing drug isotretinoin. They will compare the efficacy and safety of the two drugs used together versus isotretinoin used alone, and also explore different dosing schedules for the two drugs.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

IGA Improvement

Lesion Improvement

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Edward Lain, MDLead Sponsor

Vyne Therapeutics Inc.Industry Sponsor

34 Previous Clinical Trials

9,439 Total Patients Enrolled

1 Trials studying Acne

12 Patients Enrolled for Acne

Edward Lain, MD, MBA5.04 ReviewsPrincipal Investigator - Austin Institute for Clinical Research

Austin Institute for Clinical Research

5 Previous Clinical Trials

145 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers currently accepting volunteers for this experiment?

"At the moment, clinicaltrials.gov states that this trial is not accepting new patients, with its first posting appearing on June 28th 2021 and last update occurring March 22nd 2022. Nevertheless, there are 71 other research trials actively recruiting right now."

Answered by AI

What is the current enrollment capacity for this clinical trial?

"Currently, this trial is not recruiting. It was initially listed on June 28th 2021 and last modified on March 22nd 2022. If you are still seeking studies to join, there are 35 trials for acne sufferers actively accepting patients as well as 36 more examining the effects of Isotretinoin."

Answered by AI

Could you provide information on prior investigations related to Isotretinoin?

"Currently, 36 clinical trials involving Isotretinoin are in progress with 10 of these studies at a Phase 3 level. A majority of the trial sites for Isotretinoin are located in Perth, Western Australia however there also 727 other centres conducting research into this medication."

Answered by AI

What medical conditions does Isotretinoin commonly alleviate?

"Isotretinoin is a commonly prescribed medication for treating neuroblastoma, as well as typhus fever, disease, and relapsing fever."

Answered by AI

To what degree has Isotretinoin been found to be hazardous?

"Isotretinoin's safety has been verified, as it is currently approved for use in Phase 4 trials. Therefore, Power gave a rating of 3 to Isotretinoin."

Answered by AI

Recent research and studies

Journal of the American Academy of DermatologyJournal

A Novel Topical Minocycline Foam for the Treatment of Moderate-to-severe Acne Vulgaris: Results of 2 Randomized, Double-blind, Phase 3 Studies

Gold, Linda Stein, Sunil Dhawan, Jonathan Weiss, Zoe Diana Draelos, Herman Ellman, and Iain A. Stuart. 2019. “A Novel Topical Minocycline Foam for the Treatment of Moderate-to-severe Acne Vulgaris: Results of 2 Randomized, Double-blind, Phase 3 Studies”. Journal of the American Academy of Dermatology. Elsevier BV. doi:10.1016/j.jaad.2018.08.020.

DermatologyJournal

Oral 9-cis-retinoic Acid Versus 13-cis-retinoic Acid in Acne Therapy

Ott, F., W. Bollag, and J.-M. Geiger. 1996. “Oral 9-cis-retinoic Acid Versus 13-cis-retinoic Acid in Acne Therapy”. Dermatology. S. Karger AG. doi:10.1159/000246226.

Journal of the American Academy of DermatologyJournal

Oral 13-cis Retinoic Acid Is Superior to 9-cis Retinoic Acid in Sebosuppression in Human Beings

Geiger, Jean-Marie, Lucette Hommel, Monika Harms, and Jean-Hilaire Saurat. 1996. “Oral 13-cis Retinoic Acid Is Superior to 9-cis Retinoic Acid in Sebosuppression in Human Beings”. Journal of the American Academy of Dermatology. Elsevier BV. doi:10.1016/s0190-9622(96)90462-4.

Proceedings of the National Academy of SciencesJournal