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

N/AEnrolling By InvitationNCT06665490

Northwestern University15 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Cutaneous T Cell Lymphoma

Interventions

CLn Body WashOTHER

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.

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change of S. aureus skin microbiome

Change of S. aureus relative abundance between baseline (Week 0) and Week 8.

Time frame: 8 weeks