Effects of Treatments on the Microbiome in Healthy Volunteers and Patients With Atopic Dermatitis

Who is this study for? Patients with Atopic Dermatitis and S. aureus Bacterial Skin Infection
Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 50
Healthy Volunteers: t
View:

‣ Cohorts 1 \[NO FURTHER ACCRUAL\], 2 \[INACTIVE\], 4 \[NO FURTHER ACCRUAL\] and 5 \[INACTIVE\]: Healthy Volunteers

⁃ Males and females aged 18-50 years at time of initial protocol sampling

⁃ Subjects must participate fully and be willing to comply with the procedures of the protocol

⁃ Subjects must be co-enrolled in NIH protocol 08-HG-0059

⁃ Ability of subject to understand and provide written informed consent

⁃ Access to bathing facilities (Cohort 2 \[INACTIVE\])

⁃ Ability to swallow capsules or tablets

‣ Cohort 3 \[INACTIVE\]: Atopic Dermatitis Patients

⁃ Subjects must be aged 2-50 years

⁃ Subjects must be co-enrolled in NIH protocol 08-HG-0059

⁃ Subjects must have a diagnosis of atopic dermatitis on the basis of the criteria defined by UK Working Party s Diagnostic Criteria for Atopic Dermatitis

⁃ Subjects must have a primary care provider

⁃ Subjects must have an Objective SCORAD (SCORing Atopic Dermatitis) of greater than or equal to 15 indicating AD severity of moderate to severe

⁃ Prior to initiation of randomized treatment, subjects must have signs of bacterial skin infections (skin weeping, crusting, and/or pustules)

⁃ Access to bathing facilities

⁃ All subjects and/or their Legally Authorized Representative (LAR) must have the ability and agree to participate fully and comply with

‣ the procedures of the protocol and provide informed consent. Pediatric patients will be included in age appropriate discussions and

‣ age appropriate assent will be obtained in accordance with NIH guidelines.

• Ability of subject to understand and provide written informed consent

‣ Cohort 6: Healthy Volunteers

⁃ Subjects previously enrolled in Cohorts 1 \[NO FURTHER ACCRUAL\] and 4 \[INACTIVE\] who completed on-protocol antibiotic regimen

⁃ Subjects must participate fully and be willing to comply with the procedures of the protocol

⁃ Ability of subject to understand and provide written informed consent

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Monica E Taylor, R.N.
monica.taylor@nih.gov
(301) 451-2221
Backup
Heidi H Kong, M.D.
konghe@mail.nih.gov
(301) 827-2460
Time Frame
Start Date: 2012-09-18
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 130
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

This content was sourced from clinicaltrials.gov