RECRUITING

Open Label, Safety and Efficacy Study of QRX003 Lotion in Subjects With Netherton Syndrome

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Conditions

Netherton Syndrome

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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

To assess the safety, tolerability, and efficacy of QRX003 lotion (4%) when added to standard of care treatment regimen, including systemic therapy in subjects with Netherton syndrome

Official Title

A Multicenter, Open Label Study of QRX003 Lotion in Subjects With Netherton Syndrome

Quick Facts

Study Start:2023-03-14
Study Completion:2024-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05789056

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 CriteriaExclusion Criteria
  1. * Subject is a male or non-pregnant female at least 14 years of age.
  2. * 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.
  3. * 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.
  4. * Subject has NS lesions in the Treatment Area (i.e., arms or lower legs).
  5. * 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.
  6. * Subject is on a stable treatment regimen including systemic therapy for NS prior to baseline that is expected to remain stable for the duration of the study
  1. * Subject is pregnant, lactating, or is planning to become pregnant during the study.
  2. * 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.
  3. * Subject has active cancer of any type excluding non-melanoma skin cancer outside of the Treatment Area.
  4. * Subject has diabetes of any type, except non-insulin dependent diabetes mellitus that is reasonably controlled.
  5. * Subject has evidence of active infection during screening, or serious infection within 30 days prior to Visit 2/Baseline.
  6. * Subject has known human immunodeficiency virus, hepatitis B or C virus, or active or latent tuberculosis.
  7. * Subject has used ultraviolet phototherapy within the Treatment Area within 4 weeks prior to Visit 2/Baseline.
  8. * Subject has used topical prescription treatment in the Treatment Area within 2 weeks prior to Visit 2/Baseline.
  9. * Subject has used any topical bland moisturizers/emollients in the Treatment Area within 24 hours prior to Visit 2/Baseline.
  10. * Subject is currently enrolled in an investigational drug, biologic, or device study.
  11. * Subject has used an investigational drug, biologic, or device treatment within 30 days prior to Visit 2/Baseline.

Contacts and Locations

Study Contact

TI Clinical Research
CONTACT
858-571-1800
clinicalresearch@therapeuticsinc.com
Oleg G Khatsenko
CONTACT
858-571-1800
okhatsenko@therapeuticsinc.com

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 #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 Date2023-03-14
Study Completion Date2024-12-30

Study Record Updates

Study Start Date2023-03-14
Study Completion Date2024-12-30

Terms related to this study

Additional Relevant MeSH Terms

  • Netherton Syndrome