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mTOR inhibitor

PTX-022 for Basal Cell Carcinomas

Phase 2

Recruiting

Led By Joyce Teng, MD

Research Sponsored by Palvella Therapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 6

Awards & highlights

Study Summary

This trial is investigating whether a new topical gel is safe and effective for people with Gorlin Syndrome, a condition that causes growths on the skin.

Eligible Conditions

Basal Cell Carcinomas in Gorlin Syndrome Patients

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Incidence of dermatological, treatment emergent adverse events after treatment with active

Number of new biopsy confirmed BCCs that develop on the face compared between the active and vehicle treatment arms

Secondary outcome measures

Percentage of participants developing 1 or more new biopsy confirmed BCCs on the face.

Percentage of participants developing 2 or more new biopsy confirmed BCCs on the face.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ActiveExperimental Treatment1 Intervention

Group II: VehiclePlacebo Group1 Intervention

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Palvella Therapeutics, Inc.Lead Sponsor

6 Previous Clinical Trials

299 Total Patients Enrolled

David Bickers, MDStudy ChairColumbia University

Joyce Teng, MDPrincipal InvestigatorStanford University

2 Previous Clinical Trials

153 Total Patients Enrolled

Frequently Asked Questions

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

What is the geographical distribution of this trial?

"14 research sites are associated with this trial, including Stanford Univeristy in Palo Alto, Ameriderm Research in Ormond Beach and DermResearch Inc in Austin."

Answered by AI

To what extent is participation in this experiment widespread?

"To complete the trial, Palvella Therapeutics Inc. needs to recruit 60 qualified participants from a variety of sites including Stanford Univeristy in Palo Alto and Ameriderm Research in Ormond Beach."

Answered by AI

Has PTX-022 been given the blessing of governmental regulators?

"PTX-022 has been allocated a safety rating of 2, as there is only limited evidence supporting its security. No tests have yet verified the efficacy of this drug."

Answered by AI

Is participation in this experiment still a viable option?

"According to the data on clinicaltrials.gov, this research project is currently enrolling participants. It was originally posted in May 2021 and most recently updated at the end of August 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CODY: A Study Evaluating The Safety And Efficacy Of QTORIN 3.9% Sirolimus Topical Gel For The Prevention Of Basal Cell Carcinomas (BCCs) In Patients With Gorlin Syndrome

2021. "CODY: A Study Evaluating The Safety And Efficacy Of QTORIN 3.9% Sirolimus Topical Gel For The Prevention Of Basal Cell Carcinomas (BCCs) In Patients With Gorlin Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04893486.