Test to Determine the Effectiveness of Moisturizing Balm Used on Babies With Dry, Itchy Skin

NCT02404493 | Terminated Results

• 1 other identifier: CO-141020101115-THCT
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this 3 week study is to test the effectiveness of an over-the-counter (OTC) skin balm in infants and toddlers with mild to moderate dry, itchy skin.

Conditions

Eczema

Keywords

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Mean Corneometer Measurement Immediately Following Treatment

  Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.

  Day 0 - Pretreatment (Baseline) to Day 0 - immediately post treatment

• Change From Baseline in Mean Corneometer Measurement 12 Hours After Treatment

  Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.

  Day 0 - Pretreatment (Baseline) to 12 Hours After treatment

Secondary Outcomes (116)

• Change From Baseline in Mean Corneometer Measurement 24 Hours After Treatment

  Day 0 - Pretreatment (Baseline) to 24 Hours After treatment

• Change From Baseline in Mean Corneometer Measurement 3 Days After Treatment

  Day 0 - Pretreatment (Baseline) to 3 Days After treatment

• Change From Baseline in Mean Corneometer Measurement 7 Days After Treatment

  Day 0 - Pretreatment (Baseline) to 7 Days After treatment

• Change From Baseline in Mean Corneometer Measurement 14 Days After Treatment

  Day 0 - Pretreatment (Baseline) to 14 Days After treatment

• Eczema Area and Severity Index (EASI) on Day 1 - Change From Baseline

  Day 0 - Pretreatment (Baseline) to Day 1

Study Arms (2)

EpiCeram Skin Barrier Emulsion

ACTIVE COMPARATOR

Marketed. Apply in a thin layer to the affected skin areas two times per day (or as needed) and massage gently into the skin.

Device: EpiCeram Skin Barrier Emulsion

1% Colloidal Oatmeal Balm

EXPERIMENTAL

Not Yet Marketed. Apply in a thin layer to the affected skin areas at least once at night or more if needed (anytime), and massage gently into the skin.

Drug: 1% Colloidal Oatmeal Balm

Interventions

EpiCeram Skin Barrier Emulsion DEVICE

EpiCeram Skin Barrier Emulsion

EpiCeram Skin Barrier Emulsion

1% Colloidal Oatmeal Balm DRUG

Experimental Product 1% Colloidal Oatmeal Balm

Also known as: Eczema Moisturizing Balm

1% Colloidal Oatmeal Balm

Eligibility Criteria

• Age: 6 Months - 47 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates)
• Male or female of any race or ethnicity, 6 months to 47 months of age;
• Diagnosed as having eczema
• Willing to stop use of all non-assigned moisturizers and/or creams for the entire duration of the study
• Child must have bedtime/sleep issues due to their dry, itchy skin

You may not qualify if:

• Use of a therapeutic (over-the-counter or prescription) body wash that contains an active ingredient for eczema
• Participation in any clinical study within 30 days of Visit 1
• Active infection of any type at the start of the study
• Diagnosed as having severe eczema
• Atopic Dermatitis requiring systemic, super-potent (Class I) or potent (Class II or III) topical corticosteroids
• Child wakes up 3 or more times during the night
• Child is awake more than 60 minutes during the night
• Child sleeps for less than a total of 9 hours (during the day or night)
• Child requires greater than 2.0 mg per day of inhaled or intranasal corticosteroids

Sponsors & Collaborators

• Johnson & Johnson Consumer Inc. (J&JCI): lead

Study Sites (1)

TKL Research

Fair Lawn, New Jersey, 07410, United States

Location

MeSH Terms

Conditions

Eczema; Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Limitations and Caveats

A decision was made by the sponsor to terminate the study prior to enrolling 50 subjects as enrollment was not completed prior to the summer months, and the incidence of atopic dermatitis is low in the summer months.

Results Point of Contact

• Title: Amisha Parikh-Das, PhD/Study Director
• Organization: Johnson & Johnson Consumer, Inc

AParikh1@its.jnj.com

973-255-8701 USA EST

Study Officials

• Amisha Parikh-Das, PhD

  Johnson & Johnson Consumer Inc. (J&JCI)

  STUDY DIRECTOR

• Ethlynn Schorr, MD

  TKL Research, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2015
• First Posted: March 31, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 24, 2017
• Results First Posted: March 24, 2017

Record last verified: 2017-02

Locations

US (1)