Other Clinical Trial - A Phase 3 Randomized, Double-Blind,

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study Evaluating Safety and Efficacy of QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Microcystic Lymphatic Malformations — SELVA

Microcystic Lymphatic Malformation Clinical Trial

Official title:
A Multicenter, Phase 3 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Microcystic Lymphatic Malformations

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05050149` - Study Evaluating the Safety and Efficacy of PTX-022 (QTORIN Sirolimus) in the Treatment of Microcystic Lymphatic Malformations	Phase 2
Active, not recruiting	`NCT00975819` - Safety and Efficacy Study of Sirolimus in Complicated Vascular Anomalies	Phase 2
Recruiting	`NCT06160739` - Role of Sirolimus in Treatment of Microcystic , Mixed Lymphatic and Vascular Malformations

See also

Status

Clinical Trial

Phase

Recruiting

NCT05050149 - Study Evaluating the Safety and Efficacy of PTX-022 (QTORIN Sirolimus) in the Treatment of Microcystic Lymphatic Malformations

Phase 2

Active, not recruiting

NCT00975819 - Safety and Efficacy Study of Sirolimus in Complicated Vascular Anomalies

Phase 2

Recruiting

NCT06160739 - Role of Sirolimus in Treatment of Microcystic , Mixed Lymphatic and Vascular Malformations

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT06239480
Study type	Interventional
Source	Palvella Therapeutics, Inc.
Contact	Kathy Goin
Phone	484-612-2335
Email	kathy.goin@palvellatx.com
Status	Not yet recruiting
Phase	Phase 3
Start date	July 2024
Completion date	January 2026

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study Evaluating Safety and Efficacy of QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Microcystic Lymphatic Malformations — SELVA

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms