Recruiting
Phase 2

PTX-022

Sponsor:

Palvella Therapeutics, Inc.

Code:

NCT07552077

Conditions

Angiokeratomas

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Not accepted

Interventions

PTX-022

Study Details

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

Conditions

Angiokeratomas

Study ID

NCT07552077

Start date

Apr, 2026

Status verified date

Apr, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

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
  • 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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Open label

Interventions

PTX-022

topical administration of PTX-022

Primary outcome measure

  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: 3 months ]
  • Overall Angiokeratoma Investigator Global Assessment (AK-IGA) [ Time Frame: 3 months ]
  • Overall Patient Global Impression of Change (PGI-C) [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Emily Cook

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

Locations

Cleaver Medical Group

Recruiting

Dawsonville, Georgia, United States, 30534

Contacts

Dana Anderson

770.800.3455danderson@cleavermedicalgroup.com

Principal Investigator:

Nathan Cleaver, MD

Epiphany Dermatology

Recruiting

Southlake, Texas, United States, 76092

Contacts

Moraima Avalos

(214) 884 - 7558chintan@stryderesearch.com

Principal Investigator:

Todd Plott, MD

More Information

Sponsor

Palvella Therapeutics, Inc.

Last update posted

Apr 27, 2026

Last verified

Apr, 2026

Keywords

  • angiokeratoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Palvella Therapeutics, Inc. on 2026-04-27.