Skin Care
Conditions
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.
Interventions
OTHERTest 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.
OTHERTest 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.
OTHERTest 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.
Sponsors
TKL Research, Inc.
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 18 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability Assessment of Test Products | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Overall Dry Skin [ODS] Score at Day 14 (Visual Assessment of Skin) | At baseline and day 14 | 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. |
Countries
United Kingdom
Participant flow
Recruitment details
All the participants were recruited from one center in United Kingdom.
Pre-assignment details
A total of 32 participants were screened and enrolled in the study, out of which 31 participants were randomized to the study and 1 participant was screening failure as participant did not meet study criteria.
Participants by arm
| Arm | Count |
|---|---|
| Test Shampoo Participants were instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks. | 10 |
| Test Bath Foam Participants were instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks. | 10 |
| Test Head to Toe Wash Participants were instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks. | 11 |
| Total | 31 |
Baseline characteristics
| Characteristic | Test Shampoo | Test Bath Foam | Test Head to Toe Wash | Total |
|---|---|---|---|---|
| Age, Continuous | 9.0 Months STANDARD_DEVIATION 5.62 | 10.9 Months STANDARD_DEVIATION 4.2 | 10.1 Months STANDARD_DEVIATION 3.86 | 10.0 Months STANDARD_DEVIATION 4.51 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 10 Participants | 11 Participants | 30 Participants |
| Sex: Female, Male Female | 8 Participants | 4 Participants | 4 Participants | 16 Participants |
| Sex: Female, Male Male | 2 Participants | 6 Participants | 7 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 11 |
| other Total, other adverse events | 4 / 10 | 3 / 10 | 3 / 11 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 11 |
Outcome results
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.
Time frame: At Day 14
Population: Safety population (overall): included all the participants who received at least one of the test product. Participants were further divided in two age strata Age \<12 months and Age ≥ 12 months.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Test Shampoo | Tolerability Assessment of Test Products | Overall | Score 5 (Very poor) | 0 Participants |
| Test Shampoo | Tolerability Assessment of Test Products | Overall | Score 2 (Good) | 1 Participants |
| Test Shampoo | Tolerability Assessment of Test Products | Overall | Score 3 (Acceptable) | 0 Participants |
| Test Shampoo | Tolerability Assessment of Test Products | Overall | Score 4 (Poor) | 0 Participants |
| Test Shampoo | Tolerability Assessment of Test Products | Overall | Score 1 (Very good) | 9 Participants |
| Test Shampoo | Tolerability Assessment of Test Products | Overall | >3 (Not acceptable) | 0 Participants |
| Test Shampoo | Tolerability Assessment of Test Products | Age stratum <12 months | Score 1 (Very good) | 5 Participants |
| Test Shampoo | Tolerability Assessment of Test Products | Age stratum <12 months | Score 2 (Good) | 0 Participants |
| Test Shampoo | Tolerability Assessment of Test Products | Age stratum <12 months | Score 3 (Acceptable) | 0 Participants |
| Test Shampoo | Tolerability Assessment of Test Products | Age stratum <12 months | Score 4 (Poor) | 0 Participants |
| Test Shampoo | Tolerability Assessment of Test Products | Age stratum <12 months | Score 5 (Very poor) | 0 Participants |
| Test Shampoo | Tolerability Assessment of Test Products | Age stratum <12 months | >3 (Not acceptable) | 0 Participants |
| Test Shampoo | Tolerability Assessment of Test Products | Age stratum ≥12 months | Score 1 (Very good) | 4 Participants |
| Test Shampoo | Tolerability Assessment of Test Products | Age stratum ≥12 months | Score 2 (Good) | 1 Participants |
| Test Shampoo | Tolerability Assessment of Test Products | Age stratum ≥12 months | Score 3 (Acceptable) | 0 Participants |
| Test Shampoo | Tolerability Assessment of Test Products | Age stratum ≥12 months | Score 4 (Poor) | 0 Participants |
| Test Shampoo | Tolerability Assessment of Test Products | Age stratum ≥12 months | Score 5 (Very poor) | 0 Participants |
| Test Shampoo | Tolerability Assessment of Test Products | Age stratum ≥12 months | >3 (Not acceptable) | 0 Participants |
| Test Bath Foam | Tolerability Assessment of Test Products | Age stratum ≥12 months | >3 (Not acceptable) | 0 Participants |
| Test Bath Foam | Tolerability Assessment of Test Products | Overall | Score 1 (Very good) | 10 Participants |
| Test Bath Foam | Tolerability Assessment of Test Products | Age stratum <12 months | Score 4 (Poor) | 0 Participants |
| Test Bath Foam | Tolerability Assessment of Test Products | Age stratum ≥12 months | Score 1 (Very good) | 5 Participants |
| Test Bath Foam | Tolerability Assessment of Test Products | Overall | Score 2 (Good) | 0 Participants |
| Test Bath Foam | Tolerability Assessment of Test Products | Age stratum ≥12 months | Score 3 (Acceptable) | 0 Participants |
| Test Bath Foam | Tolerability Assessment of Test Products | Age stratum ≥12 months | Score 4 (Poor) | 0 Participants |
| Test Bath Foam | Tolerability Assessment of Test Products | Overall | Score 3 (Acceptable) | 0 Participants |
| Test Bath Foam | Tolerability Assessment of Test Products | Age stratum <12 months | Score 5 (Very poor) | 0 Participants |
| Test Bath Foam | Tolerability Assessment of Test Products | Age stratum ≥12 months | Score 5 (Very poor) | 0 Participants |
| Test Bath Foam | Tolerability Assessment of Test Products | Overall | Score 4 (Poor) | 0 Participants |
| Test Bath Foam | Tolerability Assessment of Test Products | Age stratum <12 months | Score 3 (Acceptable) | 0 Participants |
| Test Bath Foam | Tolerability Assessment of Test Products | Age stratum ≥12 months | Score 2 (Good) | 0 Participants |
| Test Bath Foam | Tolerability Assessment of Test Products | Overall | Score 5 (Very poor) | 0 Participants |
| Test Bath Foam | Tolerability Assessment of Test Products | Age stratum <12 months | Score 2 (Good) | 0 Participants |
| Test Bath Foam | Tolerability Assessment of Test Products | Age stratum <12 months | >3 (Not acceptable) | 0 Participants |
| Test Bath Foam | Tolerability Assessment of Test Products | Overall | >3 (Not acceptable) | 0 Participants |
| Test Bath Foam | Tolerability Assessment of Test Products | Age stratum <12 months | Score 1 (Very good) | 5 Participants |
| Test Head to Toe Wash | Tolerability Assessment of Test Products | Overall | >3 (Not acceptable) | 0 Participants |
| Test Head to Toe Wash | Tolerability Assessment of Test Products | Age stratum <12 months | Score 1 (Very good) | 6 Participants |
| Test Head to Toe Wash | Tolerability Assessment of Test Products | Age stratum <12 months | Score 2 (Good) | 0 Participants |
| Test Head to Toe Wash | Tolerability Assessment of Test Products | Age stratum ≥12 months | Score 3 (Acceptable) | 0 Participants |
| Test Head to Toe Wash | Tolerability Assessment of Test Products | Age stratum <12 months | Score 3 (Acceptable) | 0 Participants |
| Test Head to Toe Wash | Tolerability Assessment of Test Products | Age stratum ≥12 months | >3 (Not acceptable) | 0 Participants |
| Test Head to Toe Wash | Tolerability Assessment of Test Products | Age stratum <12 months | Score 4 (Poor) | 0 Participants |
| Test Head to Toe Wash | Tolerability Assessment of Test Products | Age stratum <12 months | Score 5 (Very poor) | 0 Participants |
| Test Head to Toe Wash | Tolerability Assessment of Test Products | Age stratum ≥12 months | Score 4 (Poor) | 0 Participants |
| Test Head to Toe Wash | Tolerability Assessment of Test Products | Age stratum <12 months | >3 (Not acceptable) | 0 Participants |
| Test Head to Toe Wash | Tolerability Assessment of Test Products | Overall | Score 1 (Very good) | 11 Participants |
| Test Head to Toe Wash | Tolerability Assessment of Test Products | Overall | Score 2 (Good) | 0 Participants |
| Test Head to Toe Wash | Tolerability Assessment of Test Products | Age stratum ≥12 months | Score 1 (Very good) | 5 Participants |
| Test Head to Toe Wash | Tolerability Assessment of Test Products | Overall | Score 3 (Acceptable) | 0 Participants |
| Test Head to Toe Wash | Tolerability Assessment of Test Products | Overall | Score 4 (Poor) | 0 Participants |
| Test Head to Toe Wash | Tolerability Assessment of Test Products | Overall | Score 5 (Very poor) | 0 Participants |
| Test Head to Toe Wash | Tolerability Assessment of Test Products | Age stratum ≥12 months | Score 2 (Good) | 0 Participants |
| Test Head to Toe Wash | Tolerability Assessment of Test Products | Age stratum ≥12 months | Score 5 (Very poor) | 0 Participants |
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.
Time frame: At baseline and day 14
Population: Safety population (overall): included all the participants who received at least one of the test product. Participants were further divided in two age strata Age \<12 months and Age ≥ 12 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Shampoo | Change From Baseline in Overall Dry Skin [ODS] Score at Day 14 (Visual Assessment of Skin) | Age Stratum <12 months | -0.8 Score on scale | Standard Deviation 0.84 |
| Test Shampoo | Change From Baseline in Overall Dry Skin [ODS] Score at Day 14 (Visual Assessment of Skin) | Overall | -1.2 Score on scale | Standard Deviation 0.79 |
| Test Shampoo | Change From Baseline in Overall Dry Skin [ODS] Score at Day 14 (Visual Assessment of Skin) | Age Stratum ≥12 months | -1.6 Score on scale | Standard Deviation 0.55 |
| Test Bath Foam | Change From Baseline in Overall Dry Skin [ODS] Score at Day 14 (Visual Assessment of Skin) | Age Stratum <12 months | -1.0 Score on scale | Standard Deviation 0.71 |
| Test Bath Foam | Change From Baseline in Overall Dry Skin [ODS] Score at Day 14 (Visual Assessment of Skin) | Overall | -0.9 Score on scale | Standard Deviation 0.57 |
| Test Bath Foam | Change From Baseline in Overall Dry Skin [ODS] Score at Day 14 (Visual Assessment of Skin) | Age Stratum ≥12 months | -0.8 Score on scale | Standard Deviation 0.45 |
| Test Head to Toe Wash | Change From Baseline in Overall Dry Skin [ODS] Score at Day 14 (Visual Assessment of Skin) | Overall | -0.5 Score on scale | Standard Deviation 0.69 |
| Test Head to Toe Wash | Change From Baseline in Overall Dry Skin [ODS] Score at Day 14 (Visual Assessment of Skin) | Age Stratum ≥12 months | -0.4 Score on scale | Standard Deviation 0.89 |
| Test Head to Toe Wash | Change From Baseline in Overall Dry Skin [ODS] Score at Day 14 (Visual Assessment of Skin) | Age Stratum <12 months | -0.7 Score on scale | Standard Deviation 0.52 |