A Tolerability Assessment Study of Three Wash Products in Infants

Skin Care Clinical Trial

Official title:

A Clinical Study in Infants to Assess the Tolerability of Three Wash Products

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02403999
• Other study ID #: 203080
• Secondary ID: RH02709
• Status: Completed
• Phase: N/A
• Start date: March 1, 2015
• Est. completion date: April 27, 2015

Study information

• Verified date: November 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 27, 2015
• Est. primary completion date: April 27, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 18 Months

Eligibility

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

Related Conditions & MeSH terms

• Skin Care

Intervention

Other:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	Edinburgh

Sponsors (2)

Lead Sponsor	Collaborator
GlaxoSmithKline	TKL Research, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline in Overall Dry Skin [ODS] Score at Day 14 (Visual Assessment of Skin)	The changes in participants' skin condition was assessed using the ODS score: where 0= Absent; 1= Faint scaling, faint roughness and dull appearance; 2= Small scales in combination with a few larger scales, slight roughness, whitish appearance; 3= Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks; 4= Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks.	At baseline and day 14