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A Study to Assess the Local Cutaneous and Ocular Tolerance of Three Developmental Facial Skin-care Formulations. | Clinical Trials | Clareo Health

COMPLETEDNA

A Study to Assess the Local Cutaneous and Ocular Tolerance of Three Developmental Facial Skin-care Formulations.

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.

NCT04557371•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

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.

Detailed Description

This will be a randomized, non-comparative, single-blind (evaluator), 3-arm, parallel-group, single-center, clinical 'in-use' study to determine the local cutaneous and ocular tolerance profiles of 3 developmental cosmetic facial skincare products; a serum, lotion, and cream in healthy females with clinically-evaluated sensitive skin as determined by a positive response to a Lactic Acid Stinging Test (LAST) with signs or symptoms of cutaneous irritation and no ophthalmological conditions. Assessments will be performed and recorded for 21 days.

Eligibility

Age

18 - 65 years

Sex

FEMALE

Healthy Volunteers

Yes

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).
+13 more criteria

Locations (1)

GSK Investigational Site

Schenefeld, Schleswig-Holstein, Germany

Key Dates

Start Date

October 12, 2020

Primary Completion Date

December 22, 2020

Completion Date

December 22, 2020

Last Updated

April 22, 2022

Enrollment

150

ACTUAL participants

Conditions

Skin Care

Interventions

Serum

OTHER

Lotion

OTHER

Cream

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 22, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Assess the Local Cutaneous and Ocular Tolerance of Three Developmental Facial Skin-care Formulations.

Inclusion Criteria

Exclusion Criteria

Evaluation of the EF192B Protection Versus No Treatment

The Effect of Almond and Extra Virgin Olive Oils on Maintaining Skin Integrity in Neonates

The Effect of Skin Care Applied With Two Different Oils on Skin Integrity and Growth Parameters in Premature Babies

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