Atopic Dermatitis Clinical Trials

Find Atopic Dermatitis Clinical Trials Near You

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
Heidi H Kong, M.D.
NIAMSderm@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