Tolerance Evaluation of a Nighttime Moisturizing Balm on Babies and Adults With Eczema

NCT02357940 | Completed Results DMC

• 1 other identifier: CO-140908134135-SBCT
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this 14-day, two phase clinical study is to test the tolerance of a new over-the-counter moisturizing balm on subjects with eczema.

Conditions

Atopic Dermatitis (AD)

Keywords

Eczema; Skin Irritation

Outcome Measures

Primary Outcomes (60)

• Percentage With Erythema on the Face at Baseline Before Investigational Product Application

  Percentage of adults and babies with erythema on the face at baseline before investigational product application

  At baseline before investigational product application

• Percentage With Erythema on the Arms at Baseline Before Investigational Product Application

  Percentage of adults and babies with erythema on the arms at baseline before investigational product application

  At baseline before investigational product application

• Percentage With Erythema on the Legs at Baseline Before Investigational Product Application

  Percentage of adults and babies with erythema on the legs at baseline before investigational product application

  At baseline before investigational product application

• Percentage With Erythema on the Torso at Baseline Before Investigational Product Application

  Percentage of adults and babies with erythema on the torso at baseline before investigational product application

  At baseline before investigational product application

• Percentage With Erythema on the Face at Baseline After Investigational Product Application

  Percentage of adults and babies with erythema on the face at baseline after investigational product application

  At baseline after investigational product application

• Percentage With Erythema on the Arms at Baseline After Investigational Product Application

  Percentage of adults and babies with erythema on the arms at baseline after investigational product application

  At baseline after investigational product application

• Percentage With Erythema on the Legs at Baseline After Investigational Product Application

  Percentage of adults and babies with erythema on the legs at baseline after investigational product application

  At baseline after investigational product application

• Percentage With Erythema on the Torso at Baseline After Investigational Product Application

  Percentage of adults and babies with erythema on the torso at baseline after investigational product application

  At baseline after investigational product application

• Percentage With Erythema on the Face at Day 1

  Percentage of adults and babies with erythema on the face at Day 1

  At Day 1

• Percentage With Erythema on the Arms at Day 1

  Percentage of adults and babies with erythema on the arms at Day 1

  At Day 1

• Percentage With Erythema on the Legs at Day 1

  Percentage of adults and babies with erythema on the legs at Day 1

  At Day 1

• Percentage With Erythema on the Torso at Day 1

  Percentage of adults and babies with erythema on the torso at Day 1

  At Day 1

• Percentage With Erythema on the Face at Day 7

  Percentage of adults and babies with erythema on the face at Day 7

  At Day 7

• Percentage With Erythema on the Arms at Day 7

  Percentage of adults and babies with erythema on the arms at Day 7

  At Day 7

• Percentage With Erythema on the Legs at Day 7

  Percentage of adults and babies with erythema on the legs at Day 7

  At Day 7

• Percentage With Erythema on the Torso at Day 7

  Percentage of adults and babies with erythema on the torso at Day 7

  At Day 7

• Percentage With Erythema on the Face at Day 14

  Percentage of adults and babies with erythema on the face at Day 14

  At Day 14

• Percentage With Erythema on the Arms at Day 14

  Percentage of adults and babies with erythema on the arms at Day 14

  At Day 14

• Percentage With Erythema on the Legs at Day 14

  Percentage of adults and babies with erythema on the legs at Day 14

  At Day 14

• Percentage With Erythema on the Torso at Day 14

  Percentage of adults and babies with erythema on the torso at Day 14

  At Day 14

• Percentage With Edema on the Face at Baseline Before Investigational Product Application

  Percentage of adults and babies with edema on the face at baseline before investigational product application

  At baseline before investigational product application

• Percentage With Edema on the Arms at Baseline Before Investigational Product Application

  Percentage of adults and babies with edema on the arms at baseline before investigational product application

  At baseline before investigational product application

• Percentage With Edema on the Legs at Baseline Before Investigational Product Application

  Percentage of adults and babies with edema on the legs at baseline before investigational product application

  At baseline before investigational product application

• Percentage With Edema on the Torso at Baseline Before Investigational Product Application

  Percentage of adults and babies with edema on the torso at baseline before investigational product application

  At baseline before investigational product application

• Percentage With Edema on the Face at Baseline After Investigational Product Application

  Percentage of adults and babies with edema on the face at baseline after investigational product application

  At baseline after investigational product application

• Percentage With Edema on the Arms at Baseline After Investigational Product Application

  Percentage of adults and babies with edema on the arms at baseline after investigational product application

  At baseline after investigational product application

• Percentage With Edema on the Legs at Baseline After Investigational Product Application

  Percentage of adults and babies with edema on the legs at baseline after investigational product application

  At baseline after investigational product application

• Percentage With Edema on the Torso at Baseline After Investigational Product Application

  Percentage of adults and babies with edema on the torso at baseline after investigational product application

  At baseline after investigational product application

• Percentage With Edema on the Face at Day 1

  Percentage of adults and babies with edema on the face at Day 1

  At Day 1

• Percentage With Edema on the Arms at Day 1

  Percentage of adults and babies with edema on the arms at Day 1

  At Day 1

• Percentage With Edema on the Legs at Day 1

  Percentage of adults and babies with edema on the legs at Day 1

  At Day 1

• Percentage With Edema on the Torso at Day 1

  Percentage of adults and babies with edema on the torso at Day 1

  At Day 1

• Percentage With Edema on the Face at Day 7

  Percentage of adults and babies with edema on the face at Day 7

  At Day 7

• Percentage With Edema on the Arms at Day 7

  Percentage of adults and babies with edema on the arms at Day 7

  At Day 7

• Percentage With Edema on the Legs at Day 7

  Percentage of adults and babies with edema on the legs at Day 7

  At Day 7

• Percentage With Edema on the Torso at Day 7

  Percentage of adults and babies with edema on the torso at Day 7

  At Day 7

• Percentage With Edema on the Face at Day 14

  Percentage of adults and babies with edema on the face at Day 14

  At Day 14

• Percentage With Edema on the Arms at Day 14

  Percentage of adults and babies with edema on the arms at Day 14

  At Day 14

• Percentage With Edema on the Legs at Day 14

  Percentage of adults and babies with edema on the legs at Day 14

  At Day 14

• Percentage With Edema on the Torso at Day 14

  Percentage of adults and babies with edema on the torso at Day 14

  At Day 14

• Percentage With Scaling on the Face at Baseline Before Investigational Product Application

  Percentage of adults and babies with scaling on the face at baseline before investigational product application

  At baseline before investigational product application

• Percentage With Scaling on the Arms at Baseline Before Investigational Product Application

  Percentage of adults and babies with scaling on the arms at baseline before investigational product application

  At baseline before investigational product application

• Percentage With Scaling on the Legs at Baseline Before Investigational Product Application

  Percentage of adults and babies with scaling on the legs at baseline before investigational product application

  At baseline before investigational product application

• Percentage With Scaling on the Torso at Baseline Before Investigational Product Application

  Percentage of adults and babies with scaling on the torso at baseline before investigational product application

  At baseline before investigational product application

• Percentage With Scaling on the Face at Baseline After Investigational Product Application

  Percentage of adults and babies with scaling on the face at baseline after investigational product application

  At baseline after investigational product application

• Percentage With Scaling on the Arms at Baseline After Investigational Product Application

  Percentage of adults and babies with scaling on the arms at baseline after investigational product application

  At baseline after investigational product application

• Percentage With Scaling on the Legs at Baseline After Investigational Product Application

  Percentage of adults and babies with scaling on the legs at baseline after investigational product application

  At baseline after investigational product application

• Percentage With Scaling on the Torso at Baseline After Investigational Product Application

  Percentage of adults and babies with scaling on the torso at baseline after investigational product application

  At baseline after investigational product application

• Percentage With Scaling on the Face at Day 1

  Percentage of adults and babies with scaling on the face at Day 1

  At Day 1

• Percentage With Scaling on the Arms at Day 1

  Percentage of adults and babies with scaling on the arms at Day 1

  At Day 1

• Percentage With Scaling on the Legs at Day 1

  Percentage of adults and babies with scaling on the legs at Day 1

  At Day 1

• Percentage With Scaling on the Torso at Day 1

  Percentage of adults and babies with scaling on the torso at Day 1

  At Day 1

• Percentage With Scaling on the Face at Day 7

  Percentage of adults and babies with scaling on the face at Day 7

  At Day 7

• Percentage With Scaling on the Arms at Day 7

  Percentage of adults and babies with scaling on the arms at Day 7

  At Day 7

• Percentage With Scaling on the Legs at Day 7

  Percentage of adults and babies with scaling on the legs at Day 7

  At Day 7

• Percentage With Scaling on the Torso at Day 7

  Percentage of adults and babies with scaling on the torso at Day 7

  At Day 7

• Percentage With Scaling on the Face at Day 14

  Percentage of adults and babies with scaling on the face at Day 14

  At Day 14

• Percentage With Scaling on the Arms at Day 14

  Percentage of adults and babies with scaling on the arms at Day 14

  At Day 14

• Percentage With Scaling on the Legs at Day 14

  Percentage of adults and babies with scaling on the legs at Day 14

  At Day 14

• Percentage With Scaling on the Torso at Day 14

  Percentage of adults and babies with scaling on the torso at Day 14

  At Day 14

Study Arms (2)

Adult Tolerance Assessment

EXPERIMENTAL

Apply thin layer of experimental product to the affected skin areas at least 2 times per day and massage gently into skin

Drug: Experimental Product

Baby (infants, toddlers, young children) Tolerance Assessment

EXPERIMENTAL

Apply thin layer of experimental product to the affected skin areas at least 2 times per day and massage gently into skin

Drug: Experimental Product

Interventions

Experimental Product DRUG

1% Colloidal Oatmeal Balm

Also known as: Eczema Moisturizing Balm

Adult Tolerance Assessment; Baby (infants, toddlers, young children) Tolerance Assessment

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female of any race or ethnicity, 6 months to 36 months of age and/or 18 years and above.
• Adult subjects only - Male or non-pregnant, non-lactating female agree to the contraceptive requirements (including female partners use of a highly effective form of birth control for 3 months.
• Diagnosed as having Eczema.
• Willing to stop the use of any non- assigned moisturizers and/or creams for the entire duration of the study.
• Willing to not introduce any new fragrances (e.g. cleansers, lotions, perfumes, etc.), or in the household environment (e.g. room fresheners, cleansing agents, laundry detergents, etc.) for the duration of the study.
• Willing to avoid excessive (more than 30 minutes) sun exposure without the use of their regular brand of sunscreen and protective clothing.
• Willing to not enter/use hot tub or whirlpool bath for the duration of the study.
• Willing to avoid the beach during the course of the study, and willing to document any activities at or in a swimming pool in the daily diary.

You may not qualify if:

• Use of a therapeutic (over the counter or prescription) body wash that contains an active ingredient for eczema.
• Adults Females who are pregnant (self-reported) or breastfeeding.
• Participation in any clinical study within 30 days of Visit 1.
• Atopic Dermatitis requiring systemic, super-potent (Class I) or potent (Class II or III) topical corticosteroids.
• Requires greater than 2.0 mg/day inhaled or intranasal corticosteroids.
• Subjects who exhibit clinically active bacterial, fungal, or viral skin infections or those who are susceptible to cutaneous infections.
• Subjects who are currently on phototherapy.

Sponsors & Collaborators

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

Study Sites (2)

Hill-top Research, Inc

St. Petersburg, Florida, 33714, United States

Location

TKL Research Inc.

Fair Lawn, New Jersey, 07410, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

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

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, Ph.D.

  Johnson & Johnson Consumer Inc. (J&JCI)

  STUDY DIRECTOR

• Daniel Hogan, M.D.

  Hill-top Research Inc.

  PRINCIPAL INVESTIGATOR

• Ethlynn Schorr, M.D.

  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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2015
• First Posted: February 6, 2015
• Study Start: January 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 10, 2017
• Results First Posted: November 15, 2016

Record last verified: 2016-11

Locations

US (2)