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Actively Recruiting

Phase 2
Age: 2Years - 50Years
All Genders
Healthy Volunteers
ID01631617

Study on How Antibiotic and Bleach Treatments Affect Skin Bacteria in People With Eczema and Healthy Adults

Led by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · Updated on 2026-08-07

130

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying how different treatments for atopic dermatitis, a chronic skin condition sometimes complicated by Staphylococcus aureus infections, affect the types and amounts of bacteria on the skin. This Phase 2 trial involves both patients with moderate to severe atopic dermatitis and healthy volunteers, aiming to understand the impact of antimicrobial treatments on the skin microbiome over time. Participants are assigned to various treatment groups receiving antibiotics such as cephalexin, doxycycline, or trimethoprimsulfamethoxazole, alone or combined with dilute bleach bath treatments or placebos. The study includes randomized, placebo-controlled, and investigator-blinded antimicrobial treatments, with some participants undergoing long-term follow-up visits to assess how these treatments alter the skin microbiome. Throughout the one-year study, participants attend regular visits for physical exams, medical history reviews, and collection of skin samples, including possible biopsies. Researchers monitor changes in the skin bacteria, assess clinical responses, and evaluate antibiotic resistance patterns. Healthy volunteers may also be invited for a one-time follow-up beyond the study year to continue microbiome assessments.

CONDITIONS

Brief Title

Effects of Treatments on Atopic Dermatitis

Who Can Participate

Age: 2Years - 50Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Males and females aged 18 to 50 years for healthy volunteers
  • Individuals aged 2 to 50 years with moderate to severe atopic dermatitis
  • Diagnosis of atopic dermatitis based on UK Working Party's criteria
  • Objective SCORAD score of 15 or higher indicating moderate to severe disease
  • Signs of bacterial skin infection before treatment
  • Access to bathing facilities
  • Ability to swallow capsules or tablets
  • Ability and willingness to comply with study procedures and provide informed consent
  • Co-enrollment in NIH protocol 08-HG-0059
Not Eligible

You will not qualify if you...

  • Females with symptoms or hormone levels consistent with perimenopause or menopause
  • Use of systemic antibiotics within 12 months before baseline for healthy volunteers
  • Use of systemic antibiotics within 8 weeks or topical antibiotics on sampling sites within 3 weeks before baseline for atopic dermatitis patients
  • Use of topical corticosteroids on sampling sites within 7 days before baseline
  • Use of topical or oral complementary/alternative medicine within 4 weeks before treatment
  • Known allergies to sulfa, beta-lactam, tetracycline drugs, lidocaine, epinephrine, or sodium hypochlorite
  • Family history of toxic epidermal necrolysis
  • History of atopic dermatitis or asthma for healthy volunteers
  • Pregnant or lactating females
  • Primary or acquired immunodeficiency including HIV infection
  • Chronic medical illnesses including psoriasis
  • Planning to receive or currently receiving investigational drugs, ultraviolet therapy, monoclonal antibodies, or systemic immunosuppressants
  • Residence or work in healthcare or similar facilities with frequent exposure to laboratory animals
  • Use of swimming pools, hot tubs, or whirlpools within 7 days before sampling
  • Smokers or users of smokeless tobacco products

Research Team

H

Heidi H Kong, M.D.

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