Pilot Study to Characterize the Microbiome in Cutaneous T... | NCT06665490

Studies
Pilot Study to Characterize the Microbiome in Cutaneous T Cell Lymphoma Skin Lesions Before and After Use of CLn® Skin Care Body Wash

NCT06665490

Sponsor

Northwestern University

Status

Enrolling by invitation

Last Update Posted

May 1, 2026Actual

Enrollment

15Estimated

Phase

Not provided

Conditions

Cutaneous T Cell Lymphoma

Interventions

CLn Body Wash

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 14, 2025Actual

Primary Completion Date

Jun 2027Estimated

Completion Date

Dec 2027Estimated

First Submitted Date

Oct 28, 2024

First Submission Date that Met QC Criteria

Oct 28, 2024

First Posted Date

Oct 30, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2026

Last Update Posted Date

May 1, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this pilot study of patients with mycosis fungoides, the most common form of CTCL, we propose to primarily evaluate the impact of daily use of the CLn Body Wash (dilute sodium hypochlorite (0.006% NaOCl)) on the microbiota of CTCL lesions. Should dilute sodium hypochlorite body wash improve the microbiome of MF, reducing the abundance of S. aureus, future, larger studies can more fully evaluate the impact on pruritus, erythema, scaling, disease evolution and its role in CTCL management.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mycosis Fungoides patients		Patients with mycosis fungoides will be enrolled at Northwestern Memorial Hospital Dermatology	Other: CLn Body Wash

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CLn Body Wash	Other	All enrolled patients will self-administer at home the commercially available study product (CLn Body Wash) containing 0.006% NaOCl body wash in a sealed, child-safe pump dispenser to use daily for 8 weeks by wetting the body thoroughly with showering, lathering the study product on the body with special attention to affected areas, leaving on the skin for 2 minutes, and rinsing off with warm water.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of S. aureus skin microbiome	Change of S. aureus relative abundance between baseline (Week 0) and Week 8.	8 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults ages 18-89 years of age with active mycosis fungoides.
Patients with concurrent and prior malignancies are allowed as long as any concurrent malignancy does not directly involve the same skin site.

Exclusion Criteria:

Patients currently or recently (within past 4 weeks) on topical or systemic antibiotics, pregnant persons, or persons with potential of becoming pregnant or are/will be breastfeeding
Patients that have initiated a new skin-directed therapy over the past month.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with mycosis fungoides (MF) will be enrolled at Northwestern Memorial Hospital Dermatology outpatient clinic at 676 N St. Clair Street, Suite 1600, Chicago, IL 60611.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alan Zhou	Northwestern University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northwestern University Department of Dermatology		Chicago	Illinois	60611	United States

Condition Browse Module

MeSH Terms

ID	Term
D016410	Lymphoma, T-Cell, Cutaneous

Ancestor Terms

ID	Term
D016399	Lymphoma, T-Cell
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided