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QRX003 Lotion for Netherton Syndrome

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Recruiting

Sponsor: Quoin Pharmaceuticals

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a medicated cream called QRX003 lotion on patients with Netherton Syndrome, a rare skin disorder. The study will check if different doses and application schedules of the lotion are safe and effective. The goal is to see if the lotion can improve skin symptoms like redness and irritation.

Do I need to stop my current medications to join the trial?

The trial requires you to stop certain medications. You must not use systemic prescription treatments for Netherton Syndrome within 4 weeks before starting the trial, systemic biologic therapy for NS, topical prescription treatments in the treatment area within 2 weeks before starting, or any topical moisturizers/emollients in the treatment area within 24 hours before starting.

What data supports the idea that QRX003 Lotion for Netherton Syndrome is an effective treatment?

The available research does not provide specific data on the effectiveness of QRX003 Lotion for Netherton Syndrome. However, it mentions other treatments like secukinumab and acitretin that have shown improvement in patients with this condition. Secukinumab led to marked skin improvement in two cases, while acitretin, combined with a moisturizer, resulted in significant skin and hair improvement in a child over several months. This suggests that while QRX003 Lotion's effectiveness isn't directly supported by the available data, other treatments have shown positive outcomes for Netherton Syndrome.¹ ² ³ ⁴ ⁵

What safety data exists for QRX003 Lotion for Netherton Syndrome?

The provided research does not contain any specific safety data for QRX003 Lotion or its variants. The articles focus on allergic reactions to natural rubber, contact dermatitis, and latex allergies, which are unrelated to QRX003 Lotion. Therefore, no relevant safety data for QRX003 Lotion is available in the provided research.⁶ ⁷ ⁸ ⁹ ¹⁰

Is QRX003 Lotion a promising drug for Netherton Syndrome?

QRX003 Lotion is a promising drug for Netherton Syndrome because it is being tested specifically for this rare skin condition, which is caused by a genetic mutation leading to severe skin problems. The focus on this specific syndrome suggests that QRX003 Lotion could offer targeted relief and improvement for patients with Netherton Syndrome.² ¹¹ ¹² ¹³ ¹⁴

Research Team

Tony Andrasfay

Principal Investigator

Therapeutics, Inc.

Eligibility Criteria

Adults with Netherton Syndrome (NS) who are in good health and have NS lesions on their arms or lower legs can join this trial. Women must not be pregnant, should use birth control, and have a negative pregnancy test. Participants shouldn't have used certain treatments for NS or any investigational drugs recently.

Inclusion Criteria

I have Netherton Syndrome and agree to genetic testing if I don't have SPINK5 mutation results.

I am not able to become pregnant, or I will use birth control during and 3 months after the study.

I am in good health with no conditions that would risk my safety in the study.

See 2 more

Exclusion Criteria

I have active cancer, not including non-melanoma skin cancer, outside the treatment area.

I have a skin condition in the treatment area that could affect the study's results.

I have used prescription skin treatment recently.

See 11 more

Treatment Details

Interventions

QRX003-2% Lotion (Topical Agent)
QRX003-4% Lotion (Topical Agent)
Vehicle (Vehicle)

Trial OverviewThe study is testing QRX003 lotion at two different strengths (2% and 4%) against a placebo lotion to see if they're safe, tolerable, and effective for treating Netherton Syndrome.

Participant Groups

4Treatment groups

Experimental Treatment

Group I: Vehicle LotionExperimental Treatment1 Intervention

Subjects will apply test article once daily in the morning (QAM) for 12 weeks

Group II: QRX003-4% QAMExperimental Treatment1 Intervention

Subjects will apply test article once daily in the morning (QAM) for 12 weeks

Group III: QRX003-4% BIDExperimental Treatment1 Intervention

Subjects will apply test article twice daily BID for 12 weeks

Group IV: QRX003-2% QAMExperimental Treatment1 Intervention

Subjects will apply test article once daily in the morning (QAM) for 12 weeks

Find a Clinic Near You

Who Is Running the Clinical Trial?

Quoin Pharmaceuticals

Lead Sponsor

Trials

Recruited

50+

Findings from Research

A study analyzing 16 brands of gloves marketed as 'accelerator-free' found that all gloves contained at least one rubber accelerator, contradicting their claims.

Specifically, dipentamethylenethiuram disulfide was detected in all gloves, and half of the samples contained multiple accelerators, highlighting a potential risk for patients with allergic contact dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are Rubber Gloves Marketed as Accelerator-Free Truly Free of Accelerators?Pillsbury, ME., Ronkainen, S., Goodier, M., et al.[2021]

Netherton syndrome (NS) is a severe genetic disorder linked to chromosome 5q32, identified through linkage analysis in 20 affected families, indicating a strong genetic basis for the condition.

This research marks a significant step towards identifying the NS gene, which could enhance our understanding of skin and immune system development, potentially leading to better treatments for affected individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Localization of the Netherton syndrome gene to chromosome 5q32, by linkage analysis and homozygosity mapping.Chavanas, S., Garner, C., Bodemer, C., et al.[2021]