Effects of Treatments on Atopic Dermatitis

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Study ID
NCT01631617
Phase
PHASE2
Status
Recruiting
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Conditions

  • Dermatitis
  • Dermatitis, Atopic
  • Eczema
  • Skin Diseases
  • Skin Diseases, Genetic

Eligibility Criteria

Sex
ALL
Age
2 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Trimethoprim/sulfamethoxazole (TMP/SMZ) — DRUG
    800/160 orally every 12 hours for 14 days
  • Cephalexin — DRUG
    500 mg orally every 8 hours for 14 days
  • Doxycycline — DRUG
    20 mg orally every 12 hours for 56 days or 100 mg orally every 12 hours for 56 days
  • Sodium hypochlorite — OTHER
    6 % dilute bleach
  • Placebo capsules — OTHER
    Capsule orally every 8 hours daily for 14 days
  • Placebo Sodium hypochlorite — OTHER
    Three times a week for 14 days

Study Details

Background: \- Atopic dermatitis, or eczema, is a chronic skin disorder. Patients sometimes have infections with S. aureus bacteria. Researchers want to study how eczema treatments affect the number and the type of bacteria on the skin. Objectives: \- To study the effect of eczema treatments on skin bacteria. Eligibility: * Individuals between 2 and 25 years of age who have moderate to severe atopic dermatitis. * Healthy volunteers between 18 and 40 years of age with no history of eczema. Design: * Participants will be screened with a physical exam and medical history. Research samples will be collected. Skin biopsies may also be performed. * All participants will be assigned to one of several study groups. * Healthy volunteers must not have taken antibiotics in the year before the start of the study. * All participants will have regular study visits during their 1-year participation. More research samples will be collected at these visits. * Healthy volunteers may be asked to come in for a one-time follow up after the 1 year mark.

Key Dates

Start date
Sep 18, 2012
Status verified
Jun 2026
Primary completion
Jan 1, 2027
Completion
Jan 1, 2027

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 1A/Cephalexin
    Cephalexin + Placebo bleach
  • Active Comparator: 1B/TMP/SMX
    TMP/SMZ DS 800 /160 orally every 12 hours for 14 days
  • Active Comparator: 1C/Doxycycline 100
    Doxycycline 100 mg orally every 12 hours for 56 days
  • Active Comparator: 1D/Doxycycline 20
    Doxycycline 20 mg orally every 12 hours for 56 days
  • Active Comparator: 2A/Cephalexin + Dilute bleach
    Systemic antibiotics (Cephalexin) + dilute bleach study bath liquid
  • Placebo Comparator: 2B/Cephalexin + Placebo bleach
    Systemic antibiotics (Cephalexin) + placebo study bath liquid
  • Placebo Comparator: 2C/Placebo capsules + Dilute bleach
    Placebo capsules + dilute bleach study bath liquid
  • Placebo Comparator: 2D/Placebo capsules + Placebo bleach
    Placebo capsules + placebo study bath liquid
  • Active Comparator: 3A/Cephalexin + Dilute bleach
    Systemic antibiotics (Cephalexin) + dilute bleach study bath liquid
  • Placebo Comparator: 3B/Cephalexin + Placebo bleach
    Systemic antibiotics (Cephalexin) + placebo study bath liquid

Primary Outcome Measure

Characterize microbiome alterations [ Time Frame: 2 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
NIH Clinical Center Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

Find similar trials in Bethesda, MD

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
National Institutes of Health Clinical Center· Bethesda, MD

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