NCT07552077

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
16mo left

Started Apr 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Apr 2026Sep 2027

Study Start

First participant enrolled

April 1, 2026

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 27, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

April 20, 2026

Last Update Submit

April 20, 2026

Conditions

Angiokeratomas

Keywords

angiokeratoma

Outcome Measures

Primary Outcomes (3)

  • Incidence of Treatment-Emergent Adverse Events

    3 months

  • Overall Angiokeratoma Investigator Global Assessment (AK-IGA)

    3 months

  • Overall Patient Global Impression of Change (PGI-C)

    3 months

Study Arms (1)

Open label

EXPERIMENTAL
Drug: PTX-022

Interventions

PTX-022DRUG

topical administration of PTX-022

Open label

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unified Health

Sherman Oaks, California, 91403, United States

NOT YET RECRUITING

Cleaver Medical Group

Dawsonville, Georgia, 30534, United States

RECRUITING

Vividia Dermatology

Las Vegas, Nevada, 89148, United States

NOT YET RECRUITING

Epiphany Dermatology

Southlake, Texas, 76092, United States

RECRUITING

MeSH Terms

Conditions

Angiokeratoma

Condition Hierarchy (Ancestors)

Neoplasms, Vascular TissueNeoplasms by Histologic TypeNeoplasms

Central Study Contacts

Emily Cook

CONTACT

267-738-6366emily.cook@palvellatx.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2026

First Posted

April 27, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

April 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Locations

US(4)