Clinical Trials Logo
  1. Home
  2. Dermatitis
  3. NCT02979210
  4. Details
NCT02979210 Clinical Trial

Infant Fecal Insult Study

Dermatitis Clinical Trial

Official title:
Fecal Insult Study: An Exploratory Study to Evaluate the Microbial Consortia and Skin Barrier Function After Exposure to Artificial Fecal Irritants

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02979210
Other study ID # 500-16-0003
Secondary ID
Status Completed
Phase N/A
First received November 29, 2016
Last updated August 15, 2017
Start date November 2016
Est. completion date February 1, 2017

Study information
Verified date August 2017
Source Kimberly-Clark Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The rationale for the study is to better understand the dynamics of skin microflora following skin barrier disruption in an adult dermatitis model. The results from this study will provide insights in the complex interaction between skin microbiome and epidermis under normal and disease conditions

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date February 1, 2017
Est. primary completion date January 26, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- Healthy Subjects with Fitzpatrick Skin Types I, II or III

Exclusion Criteria:

- Subjects with visible skin disease, tattoos, skin condition, or abnormal skin color

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Artificial Fecal Insult
protease/bile acid cocktail 200 microliters (1500 µg/ml trypsin/chymotrypsin protease mixture, 6.5 mg/ml cholic acid sodium, 6.2 mg/ml deoxycholic acid sodium, and 3.1 mg/ml chenodeoxycholic acid sodium in phosphate buffered saline
• Phosphate Buffered Saline
200 microliters of phosphate buffered saline

Locations
Country Name City State
United States Reliance Clinical Testing Service Irving Texas

Sponsors (1)
Lead Sponsor Collaborator
Kimberly-Clark Corporation

Country where clinical trial is conducted

United States, 

References & Publications (2)

Costello EK, Lauber CL, Hamady M, Fierer N, Gordon JI, Knight R. Bacterial community variation in human body habitats across space and time. Science. 2009 Dec 18;326(5960):1694-7. doi: 10.1126/science.1177486. Epub 2009 Nov 5. — View Citation

Ishikawa J, Shimotoyodome Y, Ito S, Miyauchi Y, Fujimura T, Kitahara T, Hase T. Variations in the ceramide profile in different seasons and regions of the body contribute to stratum corneum functions. Arch Dermatol Res. 2013 Mar;305(2):151-62. doi: 10.1007/s00403-012-1286-5. Epub 2012 Sep 18. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Type of microbes present on skin after exposure to artificial fecal insult Microbes will be identified by metagenomic sequencing up to 7 days
Primary Relative abundance of microbes present on skin measured in picograms of DNA up to 7 days
See also
  Status Clinical Trial Phase
Completed NCT03563066 - Effect of Benralizumab in Atopic Dermatitis Phase 2
Completed NCT02916888 - A Study Comparing the Quality of Life of Patients in the Treatment of Eczema by Pediatric Generalists and Specialists N/A
Recruiting NCT01631617 - Effects of Treatments on Atopic Dermatitis Phase 2
Completed NCT03720470 - Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy Phase 3
Recruiting NCT01012453 - A Randomised Clinical Trial in a Population of Health Care Workers With Hand Eczema N/A
Completed NCT00375713 - Randomized Phase III Study to Evaluate the Efficacy and Safety of Xyzal® (Levocetirizine) vs Zyrtec® (Cetirizine) in Subjects With Dermatitis and Eczema Phase 3
Completed NCT00001150 - Induction of Suction Blisters in Patients With Urticaria, Blistering Diseases, Inflammatory Dermatoses and Neoplastic Disorders, and in Normal Volunteers N/A
Completed NCT05247333 - Implementation of a Minor Ailment Service in Community Pharmacy Practice N/A
Withdrawn NCT04154033 - Treatment of Chronic Itch in Atopic Dermatitis With Topical Naltrexone Phase 2
Completed NCT02615912 - A Single-Center, Exploratory Study to Analyze the Dynamics of Skin Microflora Following Exposure to Surfactants N/A
Withdrawn NCT01125761 - Efficacy and Safety of the Association Drugs in Patients With Allergic Dermatitis Phase 3
Withdrawn NCT00746382 - A Placebo Controlled 4 Week Proof of Concept Study With 0.5% Roflumilast Cream in Patients With Mild Atopic Dermatitis (RO-2351-001-EM) Phase 2
Terminated NCT00176956 - Atopic Dermatitis-Like Skin Disease in Pediatric Heart Transplant Patients Phase 3
Completed NCT05001139 - Clinical Investigation on the Efficacy and Safety of Relizema Ecofoam N/A
Completed NCT00801502 - Salmon in Pregnancy Study N/A
Completed NCT00005781 - Assessment of Digital Imaging as a Tool for Diagnosing Psoriasis, Hand Rashes and Unusual Moles N/A
Completed NCT05324618 - Tacrolimus Versus Hydrocortisone in Atopic Dermatitis Phase 4
Completed NCT04826471 - Clinical Investigation on the Performance and Safety of DermoRelizema Ecofoam N/A
Recruiting NCT05891743 - Prevalence of Skin Sensitization and Dermatitis Among Epoxy-exposed Workers in the Wind Turbine Industry.
Completed NCT01840605 - A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis Phase 3