A Tolerability Assessment Study of Three Wash Products in Infants

NCT02403999 | Completed Results

• 2 other identifiers: 203080RH02709
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Skin Care

Outcome Measures

Primary Outcomes (1)

• Tolerability Assessment of Test Products

  The tolerability of the test products under normal conditions of use was assessed by the paediatrician using a 5 point scale: where score 1= very good; 2= good; 3= acceptable; 4= poor and 5= very poor.

  At Day 14

Secondary Outcomes (1)

• Change From Baseline in Overall Dry Skin [ODS] Score at Day 14 (Visual Assessment of Skin)

  At baseline and day 14

Study Arms (3)

Test shampoo

EXPERIMENTAL

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

Other: Test shampoo

Test bath foam

EXPERIMENTAL

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

Other: Test bath foam

Test head to toe Wash

EXPERIMENTAL

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

Other: Test head to toe wash

Interventions

Test shampoo 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 shampoo

Test bath foam 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 bath foam

Test head to toe wash 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.

Test head to toe Wash

Eligibility Criteria

• Age: 1 Day - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead
• TKL Research, Inc.: collaborator

Study Sites (1)

GSK Investigational Site

Edinburgh, EH1 3RH, United Kingdom

Location

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2015
• First Posted: March 31, 2015
• Study Start: March 1, 2015
• Primary Completion: April 27, 2015
• Study Completion: April 27, 2015
• Last Updated: December 27, 2018
• Results First Posted: December 27, 2018

Record last verified: 2017-11

Locations

GB (1)