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Commensal Bacteria

S. hominis A 9 Product for Eczema (TIME-1 Trial)

Phase 1
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 to day 31
Awards & highlights

TIME-1 Trial Summary

This trial will study how a new product containing infection-fighting bacteria affects the skin of patients with Atopic Dermatitis.

Eligible Conditions
  • Atopic Dermatitis

TIME-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 to day 31
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 to day 31 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The duration of ShA9 survival on the lesional ventral arm skin of atopic dermatitis (AD) participants positive for S. aureus (AD SA+)
Secondary outcome measures
The count of non-serious treatment-emergent adverse events
Therapeutic procedure
The duration of ShA9 survival on the non-lesional ventral arm skin of atopic dermatitis (AD) participants positive for S. aureus (AD SA+)

TIME-1 Trial Design

2Treatment groups
Experimental Treatment
Group I: ShA9 non-dominant and placebo dominantExperimental Treatment2 Interventions
The ShA9 product and placebo will be provided in single dose dispensers. Dispensers will be stored at -80°Celsius (= -112 degrees Fahrenheit) and thawed to 4°Celsius (=39.2 degrees Fahrenheit) prior to administration. Participants will have a single application of placebo applied by clinic staff to their dominant arm (i.e. right arm for a right handed participant) and a single application of ShA9 applied to their contralateral arm (i.e. left arm for a right handed participant).
Group II: ShA9 dominant and placebo non-dominantExperimental Treatment2 Interventions
The ShA9 product and placebo will be provided in single dose dispensers. Dispensers will be stored at -80°Celsius (= -112 degrees Fahrenheit) and thawed to 4°Celsius (=39.2 degrees Fahrenheit) prior to administration. Participants will have a single application of ShA9 applied by clinic staff to their dominant arm (i.e. right arm for a right handed participant) and a single application of placebo applied to their contralateral arm (i.e. left arm for a right handed participant).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,272 Previous Clinical Trials
5,485,579 Total Patients Enrolled
Atopic Dermatitis Research NetworkOTHER
9 Previous Clinical Trials
4,286 Total Patients Enrolled
Richard Gallo, M.D., Ph.D.Study ChairUniversity of California, San Diego: Dermatology Clinical Trials Unit
2 Previous Clinical Trials
136 Total Patients Enrolled

Media Library

S. hominis A 9 Product (Commensal Bacteria) Clinical Trial Eligibility Overview. Trial Name: NCT05177328 — Phase 1
Atopic Dermatitis Research Study Groups: ShA9 dominant and placebo non-dominant, ShA9 non-dominant and placebo dominant
Atopic Dermatitis Clinical Trial 2023: S. hominis A 9 Product Highlights & Side Effects. Trial Name: NCT05177328 — Phase 1
S. hominis A 9 Product (Commensal Bacteria) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05177328 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent has S. hominis A 9 Product been proven safe for patients?

"Our assessment of S. hominis A 9 Product's safety is relatively low, with a score of 1 out of 3 due to the preliminary nature of its clinical trials and the lack evidence for efficacy."

Answered by AI

What are the qualifications necessary to participate in this clinical trial?

"This medical trial is recruiting for 20 patients between 18 and 80 years old, suffering from infantile eczema. Eligible candidates must have 21 cm^2 of both lesional and non-lesional skin on their right and left ventral arms (which may be broken up into smaller areas). Additionally, the Investigator Global Assessment score should register as moderate or greater, while body surface area needs to fall within 1.26 m^2 to 2.25 m^2 according to Mostellar BSA Calculator calculations."

Answered by AI

Is this research endeavor actively searching for participants?

"The information hosted on clinicaltrials.gov indicates that recruitment for this medical project is open to the public. It was originally posted on July 18th 2022 and underwent its most recent modification three days later."

Answered by AI

Can septuagenarians participate in this clinical trial?

"The requirements for this trial stipulate that prospective participants must be aged between 18 and 80. Meanwhile, there are separate trials specifically designed to evaluate younger or older demographics with 101 and 165 studies respectively."

Answered by AI

How many participants have been accepted into this clinical trial?

"That is correct. According to the records accessible on clinicaltrials.gov, this trial was first posted on July 18th and has since been revised for accuracy. Currently, 20 patients are needed from a single medical facility."

Answered by AI
~6 spots leftby May 2025