Last updated: 11/03/2018 22:23:58
A single center, open-label Oilatum Daily Junior Lotion consumer study
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A single center, open-label Oilatum Daily Junior Lotion consumer study
Trial description: Oilatum Lotion D has been developed for use as a moisturiser in babies and children with mild to moderate dry skin or who have skin prone to atopic dermatitis/eczema. This single centre, non-randomised, open-label, multi-site study was designed to evaluate the effectiveness and safety of the product in the target population.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
N\A
Primary outcomes:
Change from baseline in Overall Dry Skin (ODS) score at Day 29
Timeframe: At Baseline and Day 29
Secondary outcomes:
Area under curve (AUC)BL-29 for Overall Dry Skin (ODS) score
Timeframe: Baseline up to Day 29
Change from baseline in Overall Dry Skin (ODS) score at regression period
Timeframe: At Baseline , Day 30 and 32
Change from baseline in Skin hydration values at Day 29
Timeframe: At Baseline and Day 29
Area under curve (AUC)BL-29 for skin hydration
Timeframe: Baseline up to Day 29
Change from baseline in skin hydration at regression period
Timeframe: At Baseline , Day 30 and 32
Skin feel and product attributes as measured by questionnaires
Timeframe: At Baseline, Day 1 ( 30 minutes post-use), 8, 15 and 29
Interventions:
Enrollment:
47
Primary completion date:
2014-29-06
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Skin Care
Product
Not applicable
Collaborators
Intertek CRS
Study date(s)
May 2014 to June 2014
Type
Interventional
Phase
2/3
Participation criteria
Sex
Female & Male
Age
6 Months - 3 Year
Accepts healthy volunteers
yes
- Participant’s parent/ legal guardian demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and have received a signed and dated copy of the informed consent form
- Aged at least 6 months old and no older than 3 years old at screening/ baseline visit.
- Participants with a current episode of eczema/atopic dermatitis or who have had an episode in the past month.
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
Inclusion and exclusion criteria
Inclusion criteria:
- Participant’s parent/ legal guardian demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and have received a signed and dated copy of the informed consent form
- Aged at least 6 months old and no older than 3 years old at screening/ baseline visit.
- Participant’s parent/ legal guardian understands and is willing, able and likely to comply with all study procedures and restrictions.
- Good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant and relevant abnormalities of medical history.
- Absence of any condition that would impact on the participant’s safety or wellbeing or affect the participant’s parent/ legal guardian’s ability to understand and follow study procedures and requirements
- Dry skin or atopic dermatitis/eczema-prone skin. Parent/ legal guardian reported dry, itchy, irritated skin or with a history of atopic dermatitis/eczema prone (where atopic dermatitis/eczema was diagnosed by a doctor or healthcare professional).
- Participants with a dermatologist skin grading of at least 2 using the Overall Dry Skin Score at Baseline.
Exclusion criteria:
- Participants with a current episode of eczema/atopic dermatitis or who have had an episode in the past month.
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
- Use of oral corticosteroids or immunosuppressive medications within 4 weeks or topical corticosteroids or topical anti-itch products within 2 weeks of first using study product.
- Previous participation in this study.
- Living in the same household as one of the site study staff, who is a member of their immediate family and is working directly on the study.
- Living in the same household as an employee of the sponsor.
- Living in the same household of a participant who is already enrolled in the study.
- A child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2014-29-06
Actual study completion date
2014-29-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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