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NCT01631617 · ClinicalTrials.gov registry record · Phase 2

Effects of Treatments on Atopic Dermatitis

A Phase 2 study of Eczema and Dermatitis, Atopic, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).

Recruiting
Registry status
Phase 2
Development phase
130
Enrollment target
1
Study location

NCT01631617: Recruiting Phase 2 study of Eczema and Dermatitis, Atopic, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).

NCT01631617 is a Phase 2 study of Eczema and Dermatitis, Atopic that is actively recruiting participants, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The registered enrollment target is 130 participants, below the 202-participant average among 29 other Eczema trials with a reported enrollment target (36% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01631617, a Phase 2 study of Eczema and Dermatitis, Atopic, is actively recruiting participants, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).

RECRUITING
Registry status
Phase 2
Development phase
130 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

Difference in Shannon Diversity Indices (SDI) from baseline to day 14.

Interventions

  • OTHER Placebo capsules
  • DRUG Doxycycline
  • DRUG Cephalexin
  • DRUG Trimethoprim/sulfamethoxazole (TMP/SMZ)
  • OTHER Sodium hypochlorite

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 130 participants
Start Date 2012-09-18
Est. Completion 2027-01-01
Phase Phase 2

What NCT01631617 shows while recruiting

NCT01631617 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, below the 202-participant average among 29 other Eczema trials with a reported enrollment target (36% lower).

The record links to 5 conditions, with Eczema appearing as the primary indexed condition, and to 5 interventions - of which Placebo capsules is the first listed.

NCT01631617 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT01631617 about?

NCT01631617 is a clinical study titled "Effects of Treatments on Atopic Dermatitis". 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 s...

What is the current status of trial NCT01631617?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 130 participants. The study started on 2012-09-18. Estimated completion is 2027-01-01.

What conditions does trial NCT01631617 study?

This clinical trial studies the following conditions: Eczema, Dermatitis, Atopic, Skin Diseases, Dermatitis, Skin Diseases, Genetic.

What interventions are being tested in trial NCT01631617?

The interventions under investigation include: Placebo capsules (OTHER), Doxycycline (DRUG), Cephalexin (DRUG), Trimethoprim/sulfamethoxazole (TMP/SMZ) (DRUG), Sodium hypochlorite (OTHER).

Who is sponsoring clinical trial NCT01631617?

This trial is sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01631617 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Eczema

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01631617's enrollment target sits among peer trials

130 14th of 29 higher than 16 of 29 other Eczema trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Eczema trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01631617, the US trial registry maintained by the National Library of Medicine. NCT01631617 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.