Trial to Determine the Therapeutic Benefit of an OTC Cream on Dry, Itchy Skin of Adults and Children With Eczema

NCT02691507 | Completed Phase 2 Results

• 1 other identifier: CO - 151102105611 - SACT
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of this 1 week trial is to evaluate the efficacy of an over-the-counter (OTC) 1% colloidal oatmeal skin protectant cream in adults and children with mild to moderate AD.

Conditions

Atopic Dermatitis

Keywords

Eczema, Itchy Skin

Outcome Measures

Primary Outcomes (8)

• Change From Baseline in the Itch Assessment Score Immediately Following Treatment

  The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.

  Baseline to immediately following treatment

• Change From Baseline in the Itch Assessment Score 1 Hour After Treatment

  The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.

  Baseline to one hour after treatment

• Change From Baseline in the Itch Assessment Score 2 Hours After Treatment

  The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.

  Baseline to two hours after treatment

• Change From Baseline in the Itch Assessment Score 3 Hours After Treatment

  The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.

  Baseline to three hours after treatment

• Change From Baseline in the Itch Assessment Score 4 Hours After Treatment

  The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.

  Baseline to four hours after treatment

• Change From Baseline in the Itch Assessment Score 5 Hours After Treatment

  The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.

  Baseline to five hours after treatment

• Change From Baseline in the Itch Assessment Score 6 Hours After Treatment

  The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.

  Baseline to six hours after treatment

• Change From Baseline in the Itch Assessment Score 7 Days After Treatment

  The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.

  Baseline to seven days after treatment

Secondary Outcomes (55)

• Change From Baseline in Mean Corneometer Measurement Immediately Following Treatment

  Baseline to Immediately following treatment

• Change From Baseline in Mean Corneometer Measurement 1 Hour After Treatment

  Baseline to one hour after treatment

• Change From Baseline in Mean Corneometer Measurement 2 Hours After Treatment

  Baseline to two hours after treatment

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

  Baseline to three hours after treatment

• Change From Baseline in Mean Corneometer Measurement 4 Hours After Treatment

  Baseline to four hours after treatment

Study Arms (2)

Positive Control

ACTIVE COMPARATOR

Marketed - EpiCeram(R) Skin Barrier Emulsion: Apply in a thin layer to the affected skin areas 2 times per day (or as needed) and massage gently into the skin.

Device: EpiCeram Skin Barrier Emulsion

Experimental

EXPERIMENTAL

Not Yet Marketed - 1% Colloidal Oatmeal Balm: Apply at least once per night or more if needed.

Drug: Experimental Product 1% Colloidal Oatmeal Balm

Interventions

EpiCeram Skin Barrier Emulsion DEVICE

EpiCeram Skin Barrier Emulsion

Positive Control

Experimental Product 1% Colloidal Oatmeal Balm DRUG

Experimental Product 1% Colloidal Oatmeal Balm

Also known as: Eczema Moisturizing Balm

Experimental

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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, ages 12 and older
• Diagnosed as having eczema
• Willing to stop use of all non-assigned moisturizers and/or creams for the entire duration of the study

You may not qualify if:

• Known sensitivity to any investigational product ingredient
• Females who are pregnant , breastfeeding , or planning on becoming pregnant during the study
• Individuals with a history of skin cancer
• 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
• Has a compromised immune system
• Individuals with any planned surgeries and/or invasive medical procedures during the course of the study
• Requires greater than 2.0mg/day inhaled or intranasal corticosteroids

Sponsors & Collaborators

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

Study Sites (2)

Stephens & Associates (Colorado Research Center)

Colorado Springs, Colorado, 80915, United States

Location

Stephens & Associates (Texas Reserach Center)

Richardson, Texas, 75081, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema; Pruritus

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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

• Lily Jiang, PhD

  Stephens & Associates, Inc (Texas Research Center)

  PRINCIPAL INVESTIGATOR

• Kun M Qian, MD

  Stephens & Associates, Inc (Colorado Research Center)

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2016
• First Posted: February 25, 2016
• Study Start: February 1, 2016
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: March 6, 2017
• Results First Posted: March 6, 2017

Record last verified: 2017-01

Locations

US (2)