At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 19 enrolled

Drug / intervention

PAT-001, 0.1% +3 moredrug

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02864082

NCT02864082Phase 2Completed

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A Randomized, Bilateral Comparison, Vehicle-Controlled, Safety and Tolerability Study of Topical PAT-001 for the Treatment of Congenital Ichthyosis

Patagonia Pharmaceuticals, LLC·interventional·Posted Aug 11, 2016·Updated Sep 29, 2021

In Brief

A Phase 2 clinical trial evaluating PAT-001, 0.1%, PAT-001, 0.2%, and 2 other interventions for Congenital Ichthyosis. Completed, enrolled 19 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsCongenital Ichthyosis

CountriesUnited States

Collaborators--

Timeline

Phase 2CompletedFinished

2017201820192020202120222023202420252026

First PostedAug 2016

Enrollment StartMar 2017

Primary CompletionFeb 2018

Study CompletionDec 2018

TodayJul 2026

First PostedAug 11, 2016

Enrollment StartMar 8, 2017

Primary CompletionFeb 13, 2018

Study CompletionDec 4, 2018

TodayJul 2, 2026

Enrollment to primary: 11 monthsPosted 9.9 years ago

Interventions

PAT-001, 0.1%drug

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

PAT-001, 0.2%drug

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

Vehicle for PAT-001 0.1%drug

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

Vehicle for PAT-001 0.2%drug

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