Pilot Study to Characterize the Microbiome in Cutaneous T Cell Lymphoma Skin Lesions Before and After Use of CLn® Skin Care Body Wash
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CLn Body Wash.
- Who it may be relevant to
- Registry conditions: Cutaneous T Cell Lymphoma. Basic parameters: 18 years — 89 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- 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.
Primary outcome measures
- Change of S. aureus skin microbiome [Time frame: 8 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Northwestern University Department of Dermatology — Chicago
Identifiers
NCT: NCT06665490 · STU00222221