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A Safety and Tolerability Study of Topical PAT-001 in Congenital Ichthyosis

NCT02864082 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2021-09-29

Study results available
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Summary

Congenital ichthyosis (CI) is a large, heterogeneous family of inherited skin disorders of cornification resulting from an abnormality of skin keratinization, such as scaling and thickening of the skin. Treatment options include keratolytic agents, which can abruptly lead to extensive shedding or peeling of scales. PAT-001 primarily acts as a keratolytic agent; thus, making it a potential drug candidate for the treatment of skin disorders associated with hyperkeratinization, such as CI. The current study intends to evaluate the safety and tolerability of PAT-001 in patients with CI of either the Lamellar or X-Linked subtypes.

Conditions

  • Congenital Ichthyosis

Interventions

DRUG

PAT-001, 0.1%

PAT-001 is a topical ointment. PAT-001, 0.1% contains 0.1% of active drug.

DRUG

PAT-001, 0.2%

PAT-001 is a topical ointment. PAT-001, 0.2% contains 0.2% of active drug.

DRUG

Vehicle for PAT-001 0.1%

Vehicle topical ointment contains 0.0% of active drug and is color matched to the active test article, PAT-001 0.1%.

DRUG

Vehicle for PAT-001 0.2%

Vehicle topical ointment contains 0.0% of active drug and is color matched to the active test article, PAT-001 0.2%.

Sponsors & Collaborators

  • Patagonia Pharmaceuticals, LLC

    lead INDUSTRY

Principal Investigators

  • Zachary Rome, BS · Sponsor GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-08
Primary Completion
2018-02-13
Completion
2018-12-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02864082 on ClinicalTrials.gov