ACTIVE_NOT_RECRUITING

Safety, Tolerability and Efficacy of QRX003 Lotion in Subjects With Netherton Syndrome

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study has been designed to determine the safety, tolerability and efficacy of QRX003 lotion 2%, 4% QAM or 4% BID in subjects with Netherton Syndrome (NS) in comparison to vehicle

Official Title

A Multicenter, Randomized, Vehicle-Controlled, Double-Blind, Parallel Comparison Study of QRX003 Lotion in Subjects With Netherton Syndrome

Quick Facts

Study Start:2022-06-23

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05521438

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Subject is a male or non-pregnant female at least 14 years of age. * Females must be post-menopausal , surgically sterile , or use an effective method of birth control , for the duration of the study and for 3 months following completion of treatment. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at Visit 1/Screening and Visit 2/Baseline. * Subject has a clinical diagnosis of NS and agrees to genetic testing at Visit 1/Screening for confirmation of NS diagnosis if the subject does not have test results confirming a SPINK5 mutation. * Subject has NS lesions in the Treatment Area (i.e., arms or lower legs). * Subject is in good general health and free of any disease state or physical condition that might impair evaluation of NS or exposes the subject to an unacceptable risk by study participation.	* Subject is pregnant, lactating, or is planning to become pregnant during the study. * Subject has any skin pathology in the Treatment Area or condition that, could interfere with the evaluation of the test article or requires use of interfering topical, systemic, or surgical therapy. * Subject has Fridericia-corrected QT ≥ 450 ms for males or ≥ 470 ms for females * Subject has active cancer of any type excluding non-melanoma skin cancer outside of the Treatment Area. * Subject has diabetes of any type, except non-insulin dependent diabetes mellitus that is reasonably controlled. * Subject has evidence of active infection during screening, or serious infection within 30 days prior to Visit 2/Baseline. * Subject has known human immunodeficiency virus, hepatitis B or C virus, or active or latent tuberculosis. * Subject has used ultraviolet phototherapy within the Treatment Area within 4 weeks prior to Visit 2/Baseline. * Subject has used systemic prescription treatment for NS within 4 weeks prior to Visit 2/Baseline. * Subject has used systemic biologic therapy for NS. * Subject has used topical prescription treatment in the Treatment Area within 2 weeks prior to Visit 2/Baseline. * Subject has used any topical bland moisturizers/emollients in the Treatment Area within 24 hours prior to Visit 2/Baseline. * Subject is currently enrolled in an investigational drug, biologic, or device study. * Subject has used an investigational drug, biologic, or device treatment within 30 days prior to Visit 2/Baseline.

Inclusion Criteria

Exclusion Criteria

* Subject is a male or non-pregnant female at least 14 years of age.
* Females must be post-menopausal , surgically sterile , or use an effective method of birth control , for the duration of the study and for 3 months following completion of treatment. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at Visit 1/Screening and Visit 2/Baseline.
* Subject has a clinical diagnosis of NS and agrees to genetic testing at Visit 1/Screening for confirmation of NS diagnosis if the subject does not have test results confirming a SPINK5 mutation.
* Subject has NS lesions in the Treatment Area (i.e., arms or lower legs).
* Subject is in good general health and free of any disease state or physical condition that might impair evaluation of NS or exposes the subject to an unacceptable risk by study participation.

* Subject is pregnant, lactating, or is planning to become pregnant during the study.
* Subject has any skin pathology in the Treatment Area or condition that, could interfere with the evaluation of the test article or requires use of interfering topical, systemic, or surgical therapy.
* Subject has Fridericia-corrected QT ≥ 450 ms for males or ≥ 470 ms for females
* Subject has active cancer of any type excluding non-melanoma skin cancer outside of the Treatment Area.
* Subject has diabetes of any type, except non-insulin dependent diabetes mellitus that is reasonably controlled.
* Subject has evidence of active infection during screening, or serious infection within 30 days prior to Visit 2/Baseline.
* Subject has known human immunodeficiency virus, hepatitis B or C virus, or active or latent tuberculosis.
* Subject has used ultraviolet phototherapy within the Treatment Area within 4 weeks prior to Visit 2/Baseline.
* Subject has used systemic prescription treatment for NS within 4 weeks prior to Visit 2/Baseline.
* Subject has used systemic biologic therapy for NS.
* Subject has used topical prescription treatment in the Treatment Area within 2 weeks prior to Visit 2/Baseline.
* Subject has used any topical bland moisturizers/emollients in the Treatment Area within 24 hours prior to Visit 2/Baseline.
* Subject is currently enrolled in an investigational drug, biologic, or device study.
* Subject has used an investigational drug, biologic, or device treatment within 30 days prior to Visit 2/Baseline.

Contacts and Locations

Principal Investigator

Tony Andrasfay

STUDY_DIRECTOR

Therapeutics, Inc.

Study Locations (Sites)

Site #1

San Diego, California, 92123

United States

Site #4

Indianapolis, Indiana, 46250

United States

Site #5

Quincy, Massachusetts, 02169

United States

Site #3

Charleston, South Carolina, 29425

United States

Site #2

San Antonio, Texas, 72218

United States

Collaborators and Investigators

Sponsor: Quoin Pharmaceuticals

Tony Andrasfay, STUDY_DIRECTOR, Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-23

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2022-06-23

Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

Netherton Syndrome