A Tolerability Assessment Study of Three Wash Products in Infants

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

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

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-01

Study Completion Date

2015-04-27

Brief Summary

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

This will be a single centre, evaluator blind, randomized, parallel group, stratified, two week study in healthy participants. The clinical study is designed to provide reassurance that the formulations developed for children and babies with mild to moderately dry skin and for children whose skin is prone to atopic dermatitis (eczema) are well tolerated in the target population, babies and young children with dry skin.

Related Clinical Trials

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

A Study of a Moisturizing Cream and Baby Wash in the Management of Mild to Moderate Atopic Dermatitis in Infants, Toddlers and Children

NCT04740892

Dermatitis, Atopic

COMPLETED NA

To Evaluate the in Use Tolerance of E45 Eczema Repair Emollient in Babies and Children With (Very(Dry/Atopic Skin

NCT02857062

Atopic Dermatitis / Eczema

COMPLETED NA

A Test to Determine the Usefulness and Safety of a Cream Used on Babies With Dry Itchy Skin

NCT02120833

Eczema

COMPLETED PHASE3

Comparing Cetaphil Restoraderm System Versus Standard Skin Care in Infants

NCT01375205

Atopic Dermatitis

COMPLETED NA

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

NCT02357940

Atopic Dermatitis (AD)

COMPLETED NA

Detailed Description

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

Conditions

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

Skin Care

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

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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

Test shampoo

Participants' will be instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks.

Group Type EXPERIMENTAL

Test shampoo

Intervention Type OTHER

Participants used Oilatum Soothe \& Protect Shampoo at home in place of their usual wash product at least twice weekly for a two week period.

Test bath foam

Participants' will be instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks.

Group Type EXPERIMENTAL

Test bath foam

Intervention Type OTHER

Participants used Oilatum Soothe \& Protect Bath Foam at home in place of their usual wash product at least twice weekly for a two week period.

Test head to toe Wash

Participants' will be instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks.

Group Type EXPERIMENTAL

Test head to toe wash

Intervention Type OTHER

Participants used Oilatum Soothe \& Protect Head to Toe Wash at home in place of their usual wash product at least twice weekly for a two week period.

Interventions

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

Test shampoo

Participants used Oilatum Soothe \& Protect Shampoo at home in place of their usual wash product at least twice weekly for a two week period.

Intervention Type OTHER

Test bath foam

Participants used Oilatum Soothe \& Protect Bath Foam at home in place of their usual wash product at least twice weekly for a two week period.

Intervention Type OTHER

Test head to toe wash

Participants used Oilatum Soothe \& Protect Head to Toe Wash at home in place of their usual wash product at least twice weekly for a two week period.

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* Participants up to 18 months of age at the screening/baseline visit with good general health and no major physical disabilities
* Parent/legal guardian reported dry skin
* Voluntary written informed consent form by parent/legal guardian as an evidence to understanding of the study and willingness to participate

Exclusion Criteria

* Allergy/intolerance or hypersensitivity to the study material or any of their stated ingredients
* Participant with skin condition that warrants medical intervention, current episode of eczema/atopic dermatitis or has had an episode in the 3 months prior to screening, not regular use of moisturizers (variable application frequency)
* Use of oral corticosteroids/immunosuppressive medication within 4 weeks or topical corticosteroids/topical anti-itch products within 2 weeks of baseline
* Child in Care; participants' previous participation in this study/another clinical study/receipt of investigational drug within 30 days of the screening visit
* Parent/legal guardian aged 18 years or under, employee of the sponsor or the study site or members of their immediate family
* Participant living in the same household of an already enrolled participant

Minimum Eligible Age

1 Day

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes