Skin CareNCT02403999
A Tolerability Assessment Study of Three Wash Products in Infants
A study testing Test bath foam and Test head to toe wash in people with Skin Care, run by GlaxoSmithKline at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 1 day to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Skin Care
- What is being tested?
- Test bath foam and Test head to toe wash
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2015to 27 Apr 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study in Infants to Assess the Tolerability of Three Wash Products
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
- Being tested
- Test shampoo, Test bath foam, Test head to toe wash
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test shampooOther
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 foamOther
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 washOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Test head to toe wash |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Day 14
Secondary outcomes (1)
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.
Measured: At baseline and day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study start1 Mar 2015
- Primary completion27 Apr 2015
- Study completion27 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Skin CareStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TKL Research, Inc.
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02403999
- Sponsor's protocol ID
- 203080
- Other IDs
- RH02709
- Status last verified
- Nov 2017
- First submitted
- 26 Mar 2015
- Last updated
- 27 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study in Infants to Assess the Tolerability of Three Wash Products
- ClinicalTrials.gov ID
- NCT02403999
- Acronym / sponsor ID
- 203080
- Conditions
- Skin Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- TKL Research, Inc.
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 27 Apr 2015 (actual)
- Study completion
- 27 Apr 2015 (actual)
- First posted
- 31 Mar 2015 (estimated)
- Results
- Posted 27 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test shampoo | Experimental | Other: Test shampooParticipants' will be instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks. |
| Test bath foam | Experimental | Other: Test bath foamParticipants' will be instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks. |
| Test head to toe Wash | Experimental | Other: Test head to toe washParticipants' will be instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks. |
Who may qualify
- Ages
- 1 day to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test shampooParticipants used Oilatum Soothe \& Protect Shampoo at home in place of their usual wash product at least twice weekly for a two week period. | Other | Test shampoo |
| Test bath foamParticipants used Oilatum Soothe \& Protect Bath Foam at home in place of their usual wash product at least twice weekly for a two week period. | Other | Test bath foam |
| Test head to toe washParticipants 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. | Other | Test head to toe Wash |
Primary outcome
Tolerability Assessment of Test Products
Time frame: At Day 14
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.
1 secondary outcome
Change From Baseline in Overall Dry Skin [ODS] Score at Day 14 (Visual Assessment of Skin)
Time frame: At baseline and day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Skin Care
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Enrolling by invitationPhase 2
Deployment and Evaluation of Humanoid Robotics in Coalition-Aligned Clinical Care Settings
Mobility Impairment, Clinical Workflow Optimization
Not yet recruiting
Assessing Psoriasis Treatment Outcomes
Psoriasis
RecruitingPhase 2
A Study of Different Skin Care Approaches to Prevent Skin Reactions in People With Breast Cancer Receiving Radiation Therapy After Mastectomy
Breast Cancer, Breast Cancer Female
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test bath foam and Test head to toe wash in people with Skin Care, run by GlaxoSmithKline at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability Assessment of Test Products (time frame: At Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2018.