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A Phase 2, Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX-022 (Sirolimus) Topical Gel 3.9% in the Treatment of Angiokeratomas (LOTU)

ConditionAngiokeratomas
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age6+
SponsorPalvella Therapeutics, Inc.

About this trial

The purpose of this study is to evaluate the safety and effectiveness of the experimental drug PTX-022 in the treatment of angiokeratomas

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must be 6 years or older

Diagnosed with angiokeratoma

Able and willing to comply with all protocol-related activities

Willing and able to provide written informed consent

Disqualifiers

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

Patients 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

Trial design

Design model

Single group

Treatments tested in this trial

  • PTX-022

    Drug

    topical administration of PTX-022

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Open labelExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Treatment-Emergent Adverse Events

Time frame
3 months
2

Overall Angiokeratoma Investigator Global Assessment (AK-IGA)

Time frame
3 months
3

Overall Patient Global Impression of Change (PGI-C)

Time frame
3 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Palvella Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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