Effects of Treatments on Atopic Dermatitis

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.

Conditions

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

Interventions

DRUG

Trimethoprim/sulfamethoxazole (TMP/SMZ)

800/160 orally every 12 hours for 14 days

DRUG

Cephalexin

500 mg orally every 8 hours for 14 days

DRUG

Doxycycline

20 mg orally every 12 hours for 56 days or 100 mg orally every 12 hours for 56 days

OTHER

Sodium hypochlorite

6 % dilute bleach

OTHER

Placebo capsules

Capsule orally every 8 hours daily for 14 days

OTHER

Placebo Sodium hypochlorite

Three times a week for 14 days

Sponsors & Collaborators

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

  lead NIH

Principal Investigators

• Heidi H Kong, M.D. · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-09-18

Primary Completion

2027-01-01

Completion

2027-01-01

FDA Drug

Yes

Countries

• United States

Study Locations