N/A
N=90
A Clinical Study to Investigate the Dermal and Ocular Tolerance of a Developmental Cosmetic Facial Serum Formulation in Healthy Females With Sensitive Skin
Skin Care
Bottom Line
View on ClinicalTrials.gov: NCT03640832 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: 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 — 3; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Developmental Serum (Other); Physiogel Calming Relief Anti-Redness Serum (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- GlaxoSmithKline
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
3; 0 | — |
| SECONDARY 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 |
44; 46; 1; 0 | — |
| SECONDARY 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 |
3; 1; 1; 4; 3; 4 | — |
| SECONDARY 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 |
23; 22; 10; 6; 3; 8 | — |
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.
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.
- A subject with any history of significant diseases or medical conditions known to alter skin or eye appearance or physiologic response (e.g. diabetes) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site reaction.
- A subject presenting open sores, pimples, or cysts at the application site (face).
- A subject with an active dermatosis (local or disseminated) that might interfere with the results of the study.
- A subject with a dermatologist signs and symptoms of cutaneous irritation score of 3 (severe) fo
Data sourced from ClinicalTrials.gov (NCT03640832). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.