Last updated: 06/12/2020 07:20:32
Study to Evaluate the Effect of Oilatum Emollient as a Cleansing Product on Skin Barrier
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 Cosmetic Study to Consider the Effect of Oilatum Emollient as a Cleansing Product on Skin Barrier Function Using a Forearm-Controlled Application Technique
Trial description: The purpose of this study is to test the effects of Oilatum Bath Emollient (test product) compared to water (negative control) and 4 commercially-available products when applied to the forearm using the Forearm Controlled Application Technique (FCAT)
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Change from Baseline in Transepidermal Water Loss (TEWL) values for Oilatum Bath Emollient versus aqueous cream
Timeframe: Baseline to 3 hours after last application on Day 5
Secondary outcomes:
Change from baseline in corneometer values for all products
Timeframe: Baseline to 3 hours after last application on Day 5
Change from baseline in corneometer values for Oilatum Bath Emollient and aqueous cream versus water
Timeframe: Baseline to 3 hours after last application on Day 5
Change from baseline in TEWL values for all products
Timeframe: Baseline to 3 hours after last application on Day 5
Change from baseline in skin redness using colorimetry for all products
Timeframe: Baseline to 3 hours after last application on Day 5
Interventions:
Enrollment:
45
Primary completion date:
2014-06-06
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Skin Care
Product
GSK1507202
Collaborators
Not applicable
Study date(s)
May 2014 to June 2014
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 65 Years
Accepts healthy volunteers
Yes
- Participant is willing to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Participant has skin type I-III according to Fitzpatrick Type Score.
- Women who are known to be pregnant or who are at risk of pregnancy over the duration of the study.
- Women who are breast–feeding.
Inclusion and exclusion criteria
Inclusion criteria:
- Participant is willing to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form. -Participant has skin type I-III according to Fitzpatrick Type Score. -Participant 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 and absence of any condition that would impact on the participants safety or well-being or affect the individual’s ability to understand and follow study procedures and requirements. -Moderate dry skin over most body area, as determined by the participant at the screening and baseline visit. -Participant has no signs or symptoms of eczema (no exacerbation for the previous 6 months) and has no history of skin conditions at the screening and baseline visit.
Exclusion criteria:
- Women who are known to be pregnant or who are at risk of pregnancy over the duration of the study. -Women who are breast–feeding. -Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. -Current participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit. -Previous participation in this study. -Concomitant Medication- Currently taking the following topical products applied to the volar forearm and proximities and oral treatments such as corticosteroids, topical and oral (unless inhaled), oral antibiotics, oral or topical products for treatment of acne or rosacea, topical anti-itch medications, immunosuppressive drugs, retinoids, topical and oral. -Substance abuse- Recent history (within the last 5 years) of alcohol or other substance abuse. -An employee of the sponsor or the study site or members of their immediate family. -Excessive hair, damaged skin in or around test areas, which include sunburn, uneven skin tones, tattoos, nevi, scars or other disfiguration of the test areas. -Use of self-tanning products on the test areas within 2 weeks prior to Screening. -Active skin condition eczema/atopic dermatitis/psoaris in the past 6 months in any area (not just around test site). -Currently smoke.
Trial location(s)
Location
GSK Investigational Site
Edinburgh, Edinburgh, United Kingdom, EH1 3RH
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
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
2014-06-06
Actual study completion date
2014-06-06
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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