A Clinical Study to Assess the Local Cutaneous and Ocular Tolerance of a Developmental Cosmetic Facial Serum Formulation in Healthy Females With Sensitive Skin
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Skin Care
- Sponsor
- GlaxoSmithKline
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Number of Participants With a Unit Change of Greater Than (>) 1 in Signs and Symptoms of Cutaneous Irritation Total Scores From Baseline to 21 Days of Product Use
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
To determine the local cutaneous and ocular tolerance of a developmental cosmetic facial serum in healthy females with sensitive facial skin under normal conditions of use.
Detailed Description
This is a single-center, non-comparative clinical 'in-use' study to determine the local cutaneous and ocular tolerance of a developmental cosmetic facial serum formulation in healthy female subjects aged 18 to 65 years (inclusive) with clinically evaluated sensitive skin, as determined by a positive response to a Lactic Acid Sting Test (LAST), with minimal signs or symptoms of cutaneous irritation and no signs or symptoms of ocular irritation. A reference product, proven to be suitable for use in a sensitive skin population will also be used.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject provision of a signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study before any assessment is performed.
- •A subject who is willing and able to comply with scheduled visits, the application schedule, the lifestyle guidelines, and other study procedures.
- •A subject in good general and mental health with, in the opinion of the investigator or medically qualified designee (if the investigator is not suitably qualified), no clinically significant/relevant abnormalities in medical history or upon dermatologist and ophthalmologist examination, or condition, that would impact the subject's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements.
- •A subject with sensitive facial skin, defined as a positive response to a lactic acid sting test in the nasolabial area.
- •A subject with a dermatologist signs and symptoms of cutaneous irritation score of greater than or equal to 0.5 (very slight) for erythema.
- •A subject with a dermatologist signs and symptoms of cutaneous irritation score of greater than or equal to 0.5 (very slight) for dryness.
- •A subject with a dermatologist signs and symptoms of cutaneous irritation score of 0 (none) or 0.5 (very sight) for scaling.
- •A subject with a dermatologist signs and symptoms of cutaneous irritation score of 0 (none) or 0.5 (very sight) for edema.
- •A subject with an ophthalmologist total signs and symptoms of ocular irritation score of 0 (none).
Exclusion Criteria
- •A subject who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or, a GSK CH employee directly involved in the conduct of the study or a member of their immediate family.
- •A subject who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
- •A subject with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the subject inappropriate for entry into this study.
- •A subject who is pregnant (self-reported).
- •A subject who is breastfeeding.
- •A subject with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- •A subject who, in the opinion of the investigator or medically qualified designee, should not participate in the study.
- •A subject unwilling or unable to comply with the Lifestyle Considerations required by this study, as described in this protocol.
- •A subject with current or recent (within last 6 months before the start of the study) history of atopic lesions and/or eczema.
- •A subject with a history of allergic reactions to topical-use products, cosmetics or medications or their ingredients.
Outcomes
Primary Outcomes
Number of Participants With a Unit Change of Greater Than (>) 1 in Signs and Symptoms of Cutaneous Irritation Total Scores From Baseline to 21 Days of Product Use
Time Frame: Baseline and Day 21
A qualified dermatologist visually assessed the signs and symptoms of cutaneous irritation for dermal erythema, dryness, scaling, and edema on a scale with a score range of 0 to 3, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. Cutaneous irritation total score = dermal score of erythema + dermal score of dryness + dermal score of scaling + dermal score of edema. Total possible score range is 0 to 12 (higher value indicated more cutaneous irritation). Change from baseline for 21 days of product use = total score at Day 21 minus total score at baseline. Participants with a unit change of greater than (\>) 1 in total score (TS) of cutaneous irritation from baseline to 21 days of product use, are reported in this outcome measure.
Secondary Outcomes
- Number of Participants With a Unit Change of >1 in Signs and Symptoms of Cutaneous Irritation (Self-assessment) From Baseline to 1 to 2 Hours Post First Product Use and 21 Days of Product Use(Baseline, 1-2 hours post first use, Day 21)
- Number of Participants With a Unit Change of >1 in Signs and Symptoms of Ocular Irritation Total Scores From Baseline to 21 Days of Product Use(Baseline and Day 21)
- Number of Participants With a Unit Change of >1 in Signs and Symptoms of Ocular Irritation (Self-assessment) From Baseline to 1 to 2 Hours Post First Product Use and 21 Days of Product Use(Baseline, 1-2 hours post first use, Day 21)