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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT06665490
Status
Enrolling By Invitation

Conditions

  • Cutaneous T Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jan 14, 2025
Status verified
Apr 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
15 participants (estimated)

Arms

  • Arm: Mycosis Fungoides patients
    Patients with mycosis fungoides will be enrolled at Northwestern Memorial Hospital Dermatology

Primary Outcome Measure

Change of S. aureus skin microbiome [ Time Frame: 8 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern University Department of DermatologyChicagoIllinois60611-

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By research site
Northwestern University Department of Dermatology· Chicago, IL

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