N/A N=150 Randomized Double-blind Treatment

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

Skin Care

Bottom Line

View on ClinicalTrials.gov: NCT04557371 ↗

Enrolled (actual)

150

Serious AEs

0.0%

Results posted

Apr 2022

Primary outcome: Primary: Number of Participants Determined by a Dermatologist to Have a Clinically Relevant Positive Outcome for Cutaneous Irritation After 21 Days of Product Use — 1; 0; 0 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Serum (Other); Lotion (Other); Cream (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: GlaxoSmithKline
Primary completion: Dec 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Determined by a Dermatologist to Have a Clinically Relevant Positive Outcome for Cutaneous Irritation After 21 Days of Product Use	1; 0; 0	—
SECONDARY Number of Participants Determined by an Ophthalmologist to Have a Clinically Relevant Positive Outcome for Ocular Irritation After 21 Days of Product Use	0; 0; 0	—
SECONDARY Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application	0; 1; 0; 0; 0; 1	—
SECONDARY Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use	0; 1; 0; 1; 0; 0	—
SECONDARY Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application	2; 1; 0; 0; 2; 1	—
SECONDARY Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use	2; 0; 0; 1; 1; 0	—

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.

Eligibility 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 partici

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Data sourced from ClinicalTrials.gov (NCT04557371). 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.