Last updated: 07/29/2020 08:10:08
A Clinical Efficacy Study to Investigate the Effects of an Experimental Face Cream and Serum on Facial Redness and Barrier Function of the Skin
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 Clinical Efficacy Study to Investigate the Effects of an Experimental Face Cream and Serum on Facial Redness and Barrier Function of the Skin
Trial description: This is a single center, investigator-blind, intra and inter participant, parallel, randomized study to assess the effects of the test products that were prototypes (Physiogel Anti-Redness [AR] Face Cream and Serum) and the combination of AR Face Cream + AR Serum on facial redness and skin barrier function in healthy participants with red, dry skin.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Standardized area under curve (AUC) (Baseline [BL]-29) in change from baseline in facial redness assessed by examiner for redness in Physiogel AR Face Cream versus untreated participants on Day 29
Timeframe: 30 minutes, 6 hours, day 2, day 15 and day 29
Secondary outcomes:
Standardized AUC(BL-29) in change from baseline in facial redness assessed by examiner in Physiogel AR Serum versus untreated participants on Day 29
Timeframe: 30 minutes, 6 hours, day 2, day 15 and day 29
Standardized AUC(BL-29) in change from baseline in facial redness assessed by examiner in treated versus untreated participants at Day 29
Timeframe: 30 minutes, 6 hour, day 2, day 15, day 29 and day 32
Change from baseline in a* value for redness using colorimeter on the face for treated versus untreated groups
Timeframe: At 30 minutes, 6 hours, Day 2, 15, 29 and 32
Standardized AUC(1-32) in change from baseline in facial dryness assessed by examiner in treated versus untreated participants at Day 32
Timeframe: At Baseline and Day 32
Standardized AUC(1-32) in change from baseline in facial dryness through participant self-assessment scores for treated versus untreated groups on Day 32
Timeframe: 30 minutes, 6 hour, day 2, day 15, day 29 and day 32
Standardized AUC(1-32) in change from baseline in facial redness through participant self-assessment scores for treated versus untreated groups on Day 32
Timeframe: 30 minutes, 6 hour, day 2, day 15, day 29 and day 32
Dermatologist assessment of global tolerability on the face for treated versus untreated groups on Day 29
Timeframe: At Day 29
Change in TEWL measurements of D-Squame discs following 2, 4 and 6 adhesive discs removal from face for the physiogel AR Face Cream group versus untreated groups on Day 29
Timeframe: At Day 29
Protein analysis of D-Squame discs (total of 6 adhesive discs) from face for the Physiogel AR Face Cream group versus untreated groups on Day 29
Timeframe: At Day 29
Change in skin hydration by Corneometer for Physiogel AR Face Cream versus untreated sites on the legs
Timeframe: At Day 2, 15, 29, 30, 31, 32, 33 and 34
Change from pre-challenge in TEWL measurements of D-Squame discs following 5, 10 and 15 D-Squame discs removal for Physiogel AR Face Cream versus untreated sites on the leg on Day 29
Timeframe: On Day 29 (including Pre-challenge)
To compare the skin hydration,TEWL, a* value for redness and examiner visual assessments of redness and dryness on Day 30 vs Day 29 for the Physiogel AR Face Cream versus untreated sites following a Sodium Lauryl Sulphate challenge
Timeframe: At Day 29 and Day 30 (at 15 minutes and 3 hours)
Standardized AUC(1-29) of change from baseline in TEWL on the leg for Physiogel AR Face Cream treated sites versus untreated sites
Timeframe: Day 2, 15 and 29
Protein analysis of D-Squame discs (total of 6 adhesive discs) from sites on the legs treated with Physiogel AR Face Cream versus untreated sites on Day 29
Timeframe: On Day 29
Interventions:
Enrollment:
129
Primary completion date:
2013-18-12
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Skin Care
Product
Not applicable
Collaborators
Not applicable
Study date(s)
October 2013 to December 2013
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female
Age
18 - 65 Years
Accepts healthy volunteers
Yes
- Consent: Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Age: Aged 18 to 65 years
- Pregnancy: Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
- Breast-feeding: Women who are breast–feeding.
Inclusion and exclusion criteria
Inclusion criteria:
- Consent: Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Age: Aged 18 to 65 years
- Female Participants with self reported dry, red, sensitive, reactive facial skin.
- Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions.
- General Health: Good general and mental health with, in the opinion of the investigator or medically qualified designee:a) No clinically significant chronic or acute concurrent illnesses (e.g. severe psoriasis, severe eczema) that may interfere with the study; b) Absence of any condition that would impact on the Participant’s safety or wellbeing or affect the individual’s ability to understand and follow study procedures and requirements.
- Diagnosis: a) Participant has a classification of skin type I – IV according to the Fitzpatrick scale;b) Participant has a minimum dryness grading of 1 (mild) on the face at both the Screening and Baseline visits as assessed by the Dermatologist c) Participant has a minimum redness grading of 1 (mild) on the face at the Screening visit and a minimum grading of 2 (moderate) at the Baseline visit as assessed by the Dermatologist.
Exclusion criteria:
- Pregnancy: Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
- Breast-feeding: Women who are breast–feeding.
- Menopausal women or women experiencing signs and effects of the menopause.
- Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Clinical Study: 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.
- Medication: a) Used contraindicated prescription or non prescription drugs or products within 30 days of first using study produc; b) 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;c) Participants taking medication for rosacea; d) Participants currently using oral steroids, regular use of inhaled steroids,(occasional use is permitted), topical steroids, regular use of topical anti-itch medications (occasional use permitted but not to treated area),immunosuppressive drugs and topical drugs or medication.
- Substance abuse: Recent history (within the last 1 year) of alcohol or other substance abuse.
- Medical Conditions: a) Participants with subtype 2 (papulopustular) rosacea, (subtype 1 rosacea Participants, prior to the screening visit OR during the screening visit not requiring medication for this condition, are eligible); b) Participants with atopic dermatitis.
- Moles, tattoos, scars, hairs, etc at the test areas if it is likely that they could affect the assessments.
- Personnel: An employee of the sponsor or the study site or members of their immediate family.
- Use of self-tanning products on the test areas (face and lower legs) within 2 weeks prior to the screening visit.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
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
2013-18-12
Actual study completion date
2013-18-12
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.
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