Trial Outcomes & Findings for A Tolerability Assessment Study of Three Wash Products in Infants (NCT NCT02403999)
NCT ID: NCT02403999
Last Updated: 2018-12-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
At Day 14
Results posted on
2018-12-27
Participant Flow
All the participants were recruited from one center in United Kingdom.
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
11
|
|
Overall Study
COMPLETED
|
10
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Tolerability Assessment Study of Three Wash Products in Infants
Baseline characteristics by cohort
| Measure |
Test Shampoo
n=10 Participants
Participants were instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks.
|
Test Bath Foam
n=10 Participants
Participants were 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
n=11 Participants
Participants were instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
9.0 Months
STANDARD_DEVIATION 5.62 • n=5 Participants
|
10.9 Months
STANDARD_DEVIATION 4.20 • n=7 Participants
|
10.1 Months
STANDARD_DEVIATION 3.86 • n=5 Participants
|
10.0 Months
STANDARD_DEVIATION 4.51 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At Day 14Population: 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.
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.
Outcome measures
| Measure |
Test Shampoo
n=10 Participants
Participants were instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks.
|
Test Bath Foam
n=10 Participants
Participants were 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
n=11 Participants
Participants were instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks.
|
|---|---|---|---|
|
Tolerability Assessment of Test Products
Overall · Score 1 (Very good)
|
9 Participants
|
10 Participants
|
11 Participants
|
|
Tolerability Assessment of Test Products
Overall · Score 2 (Good)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability Assessment of Test Products
Overall · Score 3 (Acceptable)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability Assessment of Test Products
Overall · Score 4 (Poor)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability Assessment of Test Products
Overall · Score 5 (Very poor)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability Assessment of Test Products
Overall · >3 (Not acceptable)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability Assessment of Test Products
Age stratum <12 months · Score 1 (Very good)
|
5 Participants
|
5 Participants
|
6 Participants
|
|
Tolerability Assessment of Test Products
Age stratum <12 months · Score 2 (Good)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability Assessment of Test Products
Age stratum <12 months · Score 3 (Acceptable)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability Assessment of Test Products
Age stratum <12 months · Score 4 (Poor)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability Assessment of Test Products
Age stratum <12 months · Score 5 (Very poor)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability Assessment of Test Products
Age stratum <12 months · >3 (Not acceptable)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability Assessment of Test Products
Age stratum ≥12 months · Score 1 (Very good)
|
4 Participants
|
5 Participants
|
5 Participants
|
|
Tolerability Assessment of Test Products
Age stratum ≥12 months · Score 2 (Good)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability Assessment of Test Products
Age stratum ≥12 months · Score 3 (Acceptable)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability Assessment of Test Products
Age stratum ≥12 months · Score 4 (Poor)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability Assessment of Test Products
Age stratum ≥12 months · Score 5 (Very poor)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Tolerability Assessment of Test Products
Age stratum ≥12 months · >3 (Not acceptable)
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At baseline and day 14Population: 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.
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.
Outcome measures
| Measure |
Test Shampoo
n=10 Participants
Participants were instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks.
|
Test Bath Foam
n=10 Participants
Participants were 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
n=11 Participants
Participants were instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks.
|
|---|---|---|---|
|
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
|
-0.8 Score on scale
Standard Deviation 0.45
|
-0.4 Score on scale
Standard Deviation 0.89
|
|
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
|
-0.9 Score on scale
Standard Deviation 0.57
|
-0.5 Score on scale
Standard Deviation 0.69
|
|
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
|
-1.0 Score on scale
Standard Deviation 0.71
|
-0.7 Score on scale
Standard Deviation 0.52
|
Adverse Events
Test Shampoo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Test Bath Foam
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Test Head to Toe Wash
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Shampoo
n=10 participants at risk
Participants were instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks.
|
Test Bath Foam
n=10 participants at risk
Participants were 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
n=11 participants at risk
Participants were instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks.
|
|---|---|---|---|
|
Infections and infestations
Tonsillitis
|
10.0%
1/10 • Up to 14 days (± 2 days)
|
0.00%
0/10 • Up to 14 days (± 2 days)
|
0.00%
0/11 • Up to 14 days (± 2 days)
|
|
Infections and infestations
Viral rash
|
10.0%
1/10 • Up to 14 days (± 2 days)
|
0.00%
0/10 • Up to 14 days (± 2 days)
|
9.1%
1/11 • Up to 14 days (± 2 days)
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
20.0%
2/10 • Up to 14 days (± 2 days)
|
0.00%
0/10 • Up to 14 days (± 2 days)
|
0.00%
0/11 • Up to 14 days (± 2 days)
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/10 • Up to 14 days (± 2 days)
|
10.0%
1/10 • Up to 14 days (± 2 days)
|
0.00%
0/11 • Up to 14 days (± 2 days)
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/10 • Up to 14 days (± 2 days)
|
10.0%
1/10 • Up to 14 days (± 2 days)
|
0.00%
0/11 • Up to 14 days (± 2 days)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/10 • Up to 14 days (± 2 days)
|
10.0%
1/10 • Up to 14 days (± 2 days)
|
0.00%
0/11 • Up to 14 days (± 2 days)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • Up to 14 days (± 2 days)
|
10.0%
1/10 • Up to 14 days (± 2 days)
|
9.1%
1/11 • Up to 14 days (± 2 days)
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/10 • Up to 14 days (± 2 days)
|
0.00%
0/10 • Up to 14 days (± 2 days)
|
9.1%
1/11 • Up to 14 days (± 2 days)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/10 • Up to 14 days (± 2 days)
|
0.00%
0/10 • Up to 14 days (± 2 days)
|
9.1%
1/11 • Up to 14 days (± 2 days)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/10 • Up to 14 days (± 2 days)
|
0.00%
0/10 • Up to 14 days (± 2 days)
|
9.1%
1/11 • Up to 14 days (± 2 days)
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/10 • Up to 14 days (± 2 days)
|
0.00%
0/10 • Up to 14 days (± 2 days)
|
9.1%
1/11 • Up to 14 days (± 2 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER