Phase 2 Completed N=12 Treatment

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

Microcystic Lymphatic Malformation

Source: ClinicalTrials.gov NCT05050149 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2025

Primary outcomePrimary: Incidence of Treatment-Emergent Adverse Events — 9; 2; 6; 2 participants

Summary

This study evaluates the safety and efficacy of PTX-022 (sirolimus) Topical Gel 3.9% w/w in the treatment of Microcystic Lymphatic Malformations. The participant will receive 3 months of PTX-022 treatment by the end of the study.

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of Treatment-Emergent Adverse Events	9; 2; 6; 2; 1; 1	—

Eligibility Criteria

Inclusion Criteria

Participants must be 6 years or older
Diagnosed with Microcystic Lymphatic Malformations
Able and willing to comply with all protocol-required activities
Willing and able to provide written informed consent

Exclusion Criteria

Any significant concurrent condition that could adversely affect participation.
Any history of allergy or hypersensitivity to sirolimus, or sirolimus-like medications or to PTX-022
Patient's deemed by the investigator as unwilling or unable to remain compliant with all tests and procedures, including adherence to study drug administration and other protocol-required activities.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05050149). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.