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mTOR Inhibitor

Sirolimus Gel for Genetic Disorders (TOIVA Trial)

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 12 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the safety and effectiveness of a gel called PTX022 (sirolimus) in treating skin conditions called cutaneous venous malformations.

Who is the study for?
This trial is for individuals with visible varicose veins, specifically cutaneous venous malformations (cVM), which may include a small part (<30%) of lymphatic malformation. It's not suitable for those who don't meet the specific criteria of having cVM.
What is being tested?
The study tests PTX-022 (Sirolimus) Topical Gel at 3.9% concentration to see if it's safe and effective in treating skin-visible varicose veins. This Phase 2 trial compares patients' conditions before and after treatment.
What are the potential side effects?
While the side effects are not explicitly listed here, topical Sirolimus can typically cause site reactions like redness, itching or irritation; systemic side effects are less common but could include issues like mouth sores or increased cholesterol.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change in Investigator Global Assessment (cVM-IGA) From Baseline to Week 12
Overall Patient Global Impression of Change (PGI-C) From Baseline to Week 12
Other study objectives
Cutaneous Venous Malformation multicomponent static scale

Side effects data

From 2020 Phase 2 & 3 trial • 852 Patients • NCT01120028
49%
Infections and infestations
20%
Surgical and medical procedures
17%
Immune system disorders
14%
Gastrointestinal disorders
12%
Investigations
10%
Metabolism and nutrition disorders
9%
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
7%
Injury, poisoning and procedural complications
5%
Cardiac disorders
4%
Respiratory, thoracic and mediastinal disorders
4%
Renal and urinary disorders
4%
Nervous system disorders
3%
General disorders and administration site conditions
2%
Blood and lymphatic system disorders
2%
Musculoskeletal and connective tissue disorders
2%
Vascular disorders
2%
Hepatobiliary disorders
1%
Eye disorders
1%
Skin and subcutaneous tissue disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Period 2: Sirolimus
Period 1: Alemtuzumab/Tacrolimus
Period 1: Basiliximab/Tacrolimus
Period 2: Tacrolimus

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single-arm, open-labelExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
QTORIN 3.9% rapamycin anhydrous gel
2021
Completed Phase 3
~90

Find a Location

Who is running the clinical trial?

Palvella Therapeutics, Inc.Lead Sponsor
7 Previous Clinical Trials
366 Total Patients Enrolled
~10 spots leftby Dec 2025
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