MedDataX Logo

Study to Examine the Benefits of Fabric Made With Lyocell/Chitosan/Ceramide in the Treatment of Children With Mild to Moderate Eczema

NCT ID: NCT02224950

Last Updated: 2017-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study will primarily focus on evaluating the benefits of using a lyocell/chitosan/ceramide fabric as a treatment for young children with mild or moderate eczema. More specifically, the study will focus on the upper limb area in these patients and will examine whether wearing a sleeve made from a lyocell/chitosan/ceramide fabric can improve eczema symptoms compared with wearing a cotton sleeve, no sleeve, or the lyocell / chitosan combination. Patients will be evaluated at 3 intervals over a 3-week period using the following four variables: an eczema severity index, amount of itching, bacteria levels in the affected areas of skin, and amount of water loss in the affected areas.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Tencel vs. Standard Cotton Therapeutic Garments as an Adjunct Treatment for Moderate to Severe Atopic Dermatitis in Children

NCT03843437

Atopic Dermatitis
WITHDRAWN NA

Topical NF-kappaB Decoy in the Treatment of Atopic Dermatitis

NCT00125333

Atopic Dermatitis
COMPLETED PHASE1/PHASE2

A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

NCT05735483

Atopic Dermatitis Eczema
ENROLLING_BY_INVITATION PHASE3

Hydrogel Patch for the Treatment of Eczema

NCT00924508

Eczema
TERMINATED NA

Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis

NCT04178967

Atopic Dermatitis
COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study will be evaluated using the following four variables: an eczema severity index, amount/severity of itching, bacteria levels in the affected areas of skin, and amount of water loss in the affected areas. The eczema severity will be scored using the EASI (upper limb subscale); itch will be assessed with a Visual Analog Scale for itch; the skin will be swabbed for bacterial cultures and results are quantified based on microbiology lab standards to be mild, moderate or heavy growth of the bacteria identified; and transepidermal water loss (TEWL) will be measured using a tewameter/capacitive moisture sensor.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atopic Dermatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Non-medicated Emollient with no Clothing Covering Upper Limb - "Baseline/Control" Cells

Group Type PLACEBO_COMPARATOR

Non-medicated Emollient plus Lyocell/Chitosan Sleeve

Intervention Type DEVICE

Sleeve 2

Non-medicated Emollient plus Lyocell/Chitosan Sleeve

Group Type ACTIVE_COMPARATOR

Non-medicated Emollient plus Cotton Sleeve

Intervention Type OTHER

Placebo Sleeve

Non-medicated Emollient plus Cotton Sleeve

Group Type PLACEBO_COMPARATOR

Placebo Sleeve

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Non-medicated Emollient plus Lyocell/Chitosan Sleeve

Intervention Type DEVICE

Non-medicated Emollient plus Cotton Sleeve

Intervention Type OTHER

Placebo Sleeve

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 3 months to 5 years
* Mild or moderate atopic dermatitis, as determined by Investigator Global Assessment Criteria

Exclusion Criteria

* Non-English speaking subjects/families
* Families unable to complete study requirements
Minimum Eligible Age

3 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kristen Hook, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UofMLyocell

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Effectiveness of Antibacterial Therapeutic Clothing Based on Silver or Chitosan as Compared With Non-antibacterial Therapeutic Clothing in Patients With Moderate to Severe Atopic Dermatitis
NCT04297215 UNKNOWN NA
Wool Clothing for the Management of Childhood Atopic Dermatitis
NCT02534428 COMPLETED NA
Efficacy and Safety of a a Biofunctional Textile in the Management of Atopic Dermatitis
NCT01597817 COMPLETED PHASE2
Barrier Enhancement for Eczema Prevention
NCT04680520 COMPLETED NA
A Study to See How Well Lebrikizumab Works in Adults and Adolescents With Moderate Atopic Dermatitis (Eczema) and High Itch Burden
NCT07006792 RECRUITING PHASE4
A Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis
NCT03443024 COMPLETED PHASE2
A Study of LY3454738 in the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis
NCT05911841 TERMINATED PHASE2
A Study of LY3471851 in Participants With Eczema
NCT04081350 COMPLETED PHASE1
To Evaluate the Safety and Efficacy of a New Device in the Management of Mild to Moderate Atopic Dermatitis in Children
NCT00886587 COMPLETED NA
Study to Assess the Safety and Efficacy of Lebrikizumab (LY3650150) in Adolescent Participants With Moderate-to-Severe Atopic Dermatitis
NCT04250350 COMPLETED PHASE3
Randomized Controlled Trial of an Eczema Care Plan
NCT02251340 COMPLETED NA
A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
NCT05559359 ACTIVE_NOT_RECRUITING PHASE3
Determine the Dose-dependent Efficacy and Safety of EC-18 in Patients With Moderate to Severe Atopic Dermatitis
NCT06487000 NOT_YET_RECRUITING PHASE2
A Study Comparing the Quality of Life of Patients in the Treatment of Eczema by Pediatric Generalists and Specialists
NCT02916888 COMPLETED
A Study of an Eczema Spot Treatment in Providing Eczema Symptoms Relief and Lasting Itch Relief to Affected Skin Area
NCT05226143 COMPLETED NA
Safety and Efficacy of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroid in Moderate-to-Severe Atopic Dermatitis.
NCT04250337 COMPLETED PHASE3
A Study of Lebrikizumab (LY3650150) With/Without Topical Corticosteroid Treatment in Participants With Moderate-to-Severe Atopic Dermatitis
NCT06280716 ACTIVE_NOT_RECRUITING PHASE3
Efficacy and Tolerability Study of Device, RD047-26 for the Treatment of Mild to Moderate Atopic Dermatitis in Adults
NCT01232985 COMPLETED PHASE2
Wool Clothing for the Management of Childhood Atopic Dermatitis (DESSINE2)
NCT04011215 COMPLETED NA
DMT210 Topical Gel in the Treatment of Atopic Dermatitis
NCT02949960 COMPLETED PHASE2
A Study to Investigate the Efficacy and Safety of Lebrikizumab in Participants With Moderate-to-Severe Atopic Hand and Foot Dermatitis
NCT06921759 RECRUITING PHASE3
Phase 2a Study to Assess the Efficacy,Safety and Tolerability of GIA632 in Adult Participants With Moderate to Severe Atopic Dermatitis
NCT07220577 RECRUITING PHASE2
A Study of LY3844583 in Healthy Participants and Participants With Atopic Dermatitis
NCT05486208 TERMINATED PHASE1
Phase 2 Study of HL-009 Liposomal Gel to Treat Mild to Moderate Atopic Dermatitis
NCT01568489 COMPLETED PHASE2
Finding Patterns In Clinical Trial Experiences of Patients With Eczema
NCT05747378 NOT_YET_RECRUITING