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mTOR inhibitor

PTX-022 for Microcystic Lymphatic Malformation

Phase 2

Recruiting

Research Sponsored by Palvella Therapeutics, Inc.

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 4 months

Awards & highlights

Study Summary

This trial is testing a new drug, PTX-022, to see if it is safe and effective in treating a skin condition called microcystic lymphatic malformations.

Eligible Conditions

Microcystic Lymphatic Malformation

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months 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 Treatment-Emergent Adverse Events

Secondary outcome measures

Change in clinician global assessment from Baseline to Month 4

Change in patient global assessment from Baseline to Month 4

Trial Design

1Treatment groups

Experimental Treatment

Group I: Experimental: PTX-022Experimental Treatment1 Intervention

PTX-022 QTORIN

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Palvella Therapeutics, Inc.Lead Sponsor

6 Previous Clinical Trials

344 Total Patients Enrolled

1 Trials studying Microcystic Lymphatic Malformation

50 Patients Enrolled for Microcystic Lymphatic Malformation

Frequently Asked Questions

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

Are there any positions available in this clinical experiment at the moment?

"Clinicaltrials.gov indicates that recruitment for this clinical trial is still ongoing, starting from September 15th 2021 and last updated on August 26th 2022."

Answered by AI

How many medical facilities are actively conducting the experiment?

"Patients are being sought at Arkansas Children's Hospital in Little Rock, Oregon Health and Science University in Portland, as well as Vascular Birthmark Institute in New york. In addition to these 3 sites, 7 other medical centres also taking part of this trial."

Answered by AI

What is the participant limit for this experiment?

"15 participants that satisfy the criteria for inclusion must take part in this research. Patients can join from Arkansas Children's Hospital, Little Rock and Oregon Health and Science University, Portland respectively."

Answered by AI

What risks do patients face when being administered PTX-022?

"PTX-022's safety was judged to be a 2 on our scale due to the amount of clinical data supporting its usage, although no efficacy data has been collected yet."

Answered by AI

Recent research and studies

Lymphatic Research and BiologyJournal

Sirolimus in the Treatment of Microcystic Lymphatic Malformations: A Systematic Review

Teng, Joyce M.C., Adrienne Hammill, Jeff Martini, and James Treat. 2022. “Sirolimus in the Treatment of Microcystic Lymphatic Malformations: A Systematic Review”. Lymphatic Research and Biology. Mary Ann Liebert Inc. doi:10.1089/lrb.2021.0103.

clinicaltrials.govStudy

Study Evaluating the Safety and Efficacy of PTX-022 (QTORIN Sirolimus) in the Treatment of Microcystic Lymphatic Malformations

2021. "Study Evaluating the Safety and Efficacy of PTX-022 (QTORIN Sirolimus) in the Treatment of Microcystic Lymphatic Malformations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05050149.