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

April 27, 2026 updated by: Xiaolong (Alan) Zhou, Northwestern University
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Department of Dermatology

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mycosis Fungoides patients
Patients with mycosis fungoides will be enrolled at Northwestern Memorial Hospital Dermatology
Other: CLn Body Wash
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Alan Zhou, Northwestern University

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 Major Dates

Study Start (Actual)

January 14, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

October 28, 2024

First Submitted That Met QC Criteria

October 28, 2024

First Posted (Actual)

October 30, 2024

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00222221

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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