Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| RH02709 | Other Identifier | GSK |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| TKL Research, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Edinburgh | EH1 3RH | 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.
All the participants were recruited from one center in United Kingdom.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | At Day 14 |
|
Up to 14 days (± 2 days)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tonsillitis | Infections and infestations | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 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. |
|
| At baseline and day 14 |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants were instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks.
| OG002 | 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. |
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Score on scale | At baseline and day 14 |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 4 |
| 10 |
| EG001 | 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. | 0 | 10 | 0 | 10 | 3 | 10 |
| EG002 | 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. | 0 | 11 | 0 | 11 | 3 | 11 |
| Viral rash | Infections and infestations | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | Systematic Assessment |
|
| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Miliaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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.
| Score 2 (Good) |
|
| Score 3 (Acceptable) |
|
| Score 4 (Poor) |
|
| Score 5 (Very poor) |
|
| >3 (Not acceptable) |
|
| Score 2 (Good) |
|
| Score 3 (Acceptable) |
|
| Score 4 (Poor) |
|
| Score 5 (Very poor) |
|
| >3 (Not acceptable) |
|
| Age Stratum <12 months |
|
|
| Age Stratum ≥12 months |
|
|