Last updated: 04/15/2019 10:21:10
An Exploratory Study to Assess Two Accelerated Models of Barrier Repair
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: An Exploratory Study to Assess Two Accelerated Models of Barrier Repair
Trial description: The study is intended to identify a method capable of measuring repair of skin barrier function in no more than two weeks. The barrier of the skin will be perturbed by tape stripping before or after product application. Barrier function will be measured at several time points to assess the degree of repair. In addition, a statistical method will be explored in the hope that results from it will be more sensitive to changes in barrier function.
Primary purpose:
Screening
Trial design:
Single Group Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Non-randomized
Primary outcomes:
Transepidermal water loss (TEWL) assessment
Timeframe: 14 days
Leg dryness assessment
Timeframe: 14 days
Measurement of Protein from D-Squame Discs
Timeframe: 14 days
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
24
Primary completion date:
2015-22-05
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Snatchfold J, Targett D. Exploratory study to evaluate two clinical methods for assessing moisturizing effect on skin barrier repair. Skin Res Technol. 2019;1-7. DOI: 10.1111/srt.12632
Medical condition
Skin Care
Product
Not applicable
Collaborators
Not applicable
Study date(s)
April 2015 to May 2015
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female
Age
18 - 65 Year
Accepts healthy volunteers
yes
- Participant demonstrating understanding of the study and willingness to participate.
- Caucasian, Pre-menopausal female.
- Pregnant or breast–feeding women
- Menopausal and peri-menopausal women or women experiencing signs and effects of the menopause (e.g. facial flushing).
Inclusion and exclusion criteria
Inclusion criteria:
- Participant demonstrating understanding of the study and willingness to participate.
- Caucasian, Pre-menopausal female.
- Good general and mental health with, in the opinion of the investigator or medically qualified designee a) No clinically significant and relevant abnormalities in medical history (e.g. severe psoriasis, severe eczema) that may interfere with the study. b) Absence of any condition that could affect the participant’s safety or well being or their ability to understand and follow study procedures and requirements.
- Participant has a minimum dryness grading of 2 (moderate) on both lower legs at the Baseline visit as assessed by a Trained Examiner. No more than 0.5 point difference in dryness between the right and left leg corresponding quadrant (upper or lower) and between the upper and lower part of either leg.
Exclusion criteria:
- Pregnant or breast–feeding women
- Menopausal and peri-menopausal women or women experiencing signs and effects of the menopause (e.g. facial flushing).
- 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 or who are scheduled to receive an investigational drug other than the study products during the study.
- Used contraindicated prescription or non-prescription drugs or medicines within 30 days of first using study product. Currently using any medication which, in the opinion of the Investigator, may affect the evaluation of the study products or place the participant at undue risk.
- Participant taking medication for any skin condition, specifically rosacea, acne or atopic dermatitis/eczema, in the test area.
- Topical or systemic use of steroids; occasional use of inhaled steroids is permitted.
- Topical or systemic antihistamines (occasional use of topical antihistamines permitted, except to area of skin to be studied), retinoids (e.g. retinoic acid or retinol), immunosuppressive drugs, anti-inflammatory drugs, aesthetic or dermatological treatment involving the area of skin to be studied.
- Recent history (within the last 1 year) of alcohol or other substance abuse.
- Participant has a skin condition in the test area e.g. rosacea, atopic dermatitis/eczema or acne.
- Moles, tattoos, scars, hairs, etc at the test areas if it is likely that they could affect the assessments.
- Use of self-tanning products on the test areas within 2 weeks prior to the screening visit.
- Participant has had prolonged, unprotected sun exposure on the legs within the last 1 week.
- Participant has visible sunburn on the lower legs at the baseline visit.
- An employee of the sponsor or the study site or members of their immediate family.
Trial location(s)
Study documents
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
Clinical study report
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
2015-22-05
Actual study completion date
2015-22-05
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
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Additional information
Exploratory study to evaluate two clinical methods for assessing moisturizing effect on skin barrier repair
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