Last updated: 02/23/2022 05:30:06
A study to assess the local cutaneous and ocular tolerance of three developmental facial skin-care formulations.
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Clinical Study to Assess the Local Cutaneous and Ocular Tolerance of Three Developmental Cosmetic Facial Skin Care Formulations in Healthy Females with Clinically Assessed Sensitive Skin.
Trial description: This study aims to determine the local cutaneous and ocular tolerance of 3 developmental skin-care products; a serum, a lotion, and a cream in healthy female subjects with clinically evaluated sensitive facial skin for 21 days.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Local cutaneous tolerance assessment of participants for irritation determined by a dermatologist on Day 21 of product use
Timeframe: Day 21
Secondary outcomes:
Local ocular tolerance assessment of participants for irritation determined by an ophthalmologist on Day 21 of product use
Timeframe: Day 21
Change from baseline in participant self-assessment scores of sign and symptoms of cutaneous irritation after 1 to 2 hours of first product application
Timeframe: Baseline and 1-2 hours post first use
Change from baseline in participant self-assessment scores of sign and symptoms of cutaneous irritation after 21 days of product use
Timeframe: Baseline and Day 21
Change from baseline in participant self-assessment scores of sign and symptoms of ocular irritation after 1 to 2 hours of first product application
Timeframe: Baseline and 1-2 hours post first use
Change from baseline in participant self-assessment scores of sign and symptoms of ocular irritation after 21 days of product use
Timeframe: Baseline and Day 21
Interventions:
Enrollment:
150
Primary completion date:
2020-22-12
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 2020 to December 2020
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female
Age
18 - 65 Years
Accepts healthy volunteers
Yes
- Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
- A participant who is willing and able to comply with scheduled visits, the application schedule, the lifestyle guidelines, and other study procedures.
- A participant 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.
Inclusion and exclusion criteria
Inclusion criteria:
- Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
- A participant who is willing and able to comply with scheduled visits, the application schedule, the lifestyle guidelines, and other study procedures.
- A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee , no clinically significant/relevant abnormalities in medical history or upon dermatologist and ophthalmologist examination, or condition, that would impact the participant’s safety, well-being 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.
- Participants with sensitive facial skin, defined as a positive response to a LAST in the nasolabial area.
- A participant with a dermatologist signs and symptoms of cutaneous irritation score of 0.5 (very slight) or greater for erythema per dermatological evaluation.
- A participant with a dermatologist signs and symptoms of cutaneous irritation score of 0.5 (very slight) or greater for dryness per dermatological evaluation.
- A participant with a dermatologist signs and symptoms of cutaneous irritation score of 0 (none) or 0.5 (very sight) for scaling per dermatological evaluation.
- A participant with a dermatologist signs and symptoms of cutaneous irritation score of 0 (none) or 0.5 (very sight) for edema per dermatological evaluation.
- A participant with an ophthalmologist total signs and symptoms of ocular irritation score of zero (0) per dermatological evaluation.
Exclusion criteria:
- A participant 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 participant 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 participant who is pregnant (self-reported) or intends to become pregnant during the study duration.
- A participant who is breastfeeding.
- A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- A participant unwilling or unable to comply with the protocol lifestyle considerations required by this study, as described in this protocol.
- A participant with current or recent (within last 6 months before the start of the study) history of atopic lesions and/or eczema.
- A participant with a history of allergic reactions to topical-use products, cosmetics or medications or their ingredients.
- A participant 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 participant presenting open sores, pimples, or cysts at the application site (face).
- A participant considered immune-compromised.
- A participant who has used any of the following topical or systemic medications up to two weeks before the screening visit: immuno-suppressants, antihistamines, non-steroidal anti-inflammatory drugs (NSAIDS), and/or corticosteroids.
- A participant who has used oral or topical treatment with vitamin A acid and/or its derivatives up to 1 month before the screening visit.
- A participant who has been vaccinated up to 1 month before the screening visit or who is intending to receive a vaccination during their participation in the study.
- A participant with a recent history (within the last 5 years) of alcohol or other substance abuse.
- A participant with any skin marks on the face that might interfere with the evaluation of possible skin reactions (e.g. pigmentation disorders, vascular malformations, scars, tattoos, excessive hair, numerous freckles).
- A participant who has previously been enrolled in this study.
- A participant 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 participant inappropriate for entry into this study.
- Participants with corneal ulcers, keratoconus, blepharitis, meibomitis, pterygium, chemosis, moderately or severe hyperaemia or other active ocular diseases.
- A participant currently using any medication which in the opinion of the investigator (medically qualified designee) may affect the evaluation of the investigational product or place the participant at undue risk.
- A participant with an active dermatosis (local or disseminated) that might interfere with the results of the study.
- A participant with a dermatologist signs and symptoms of cutaneous irritation score of 3 (severe) for edema, scaling, erythema, or dryness per dermatological evaluation.
- A participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.
Trial location(s)
Location
GSK Investigational Site
Schenefeld, Schleswig-Holstein, Germany, 22869
Status
Study Complete
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2020-22-12
Actual study completion date
2020-22-12
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.
Additional information about the trial
Additional information
Not applicable
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