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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06665490
Enrollment
15
Registered
2024-10-30
Start date
2025-01-14
Completion date
2027-12-01
Last updated
2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous T Cell Lymphoma

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.

Interventions

OTHERCLn 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.

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change of S. aureus skin microbiome8 weeksChange of S. aureus relative abundance between baseline (Week 0) and Week 8.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAlan Zhou

Northwestern University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 2, 2026