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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Skin Care

Intervention / Treatment
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* Other: Serum
* Other: Lotion
* Other: Cream


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study is a randomized, 3-arm parallel group study.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Developmental Serum<br>The participants will apply a developmental serum topically to the face twice daily (morning and evening) to freshly cleansed with normal moisturizing routine for 21 days. | Other: Serum<br>* Participants will topically apply the serum to the face as per normal home use application in place of their current facial serum product.<br>|
| Experimental: Developmental Lotion<br>The participants will apply a developmental lotion topically to the face twice daily (morning and evening) to freshly cleansed skin for 21 days. | Other: Lotion<br>* Participants will topically apply lotion to the face as per normal home use application in place of their current facial lotion product.<br>|
| Experimental: Developmental Cream<br>The participants will apply a developmental cream topically to the face twice daily (morning and evening) to freshly cleansed skin for 21 days. | Other: Cream<br>* Participants will topically apply cream to the face as per normal home use application in place of their current facial cream product.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Determined by a Dermatologist to Have a Clinically Relevant Positive Outcome for Cutaneous Irritation After 21 Days of Product Use | The clinically relevant positive outcome for cutaneous irritation was defined as the number of participants who experienced an increase in total cutaneous irritation score at Day 21 versus Baseline that was deemed clinically-relevant by the examiner. The dermatologist assessment of signs and symptoms of cutaneous irritation total score was calculated as the sum of the individual cutaneous response attributes (erythema, dryness, scaling, and edema). Each attribute was assessed on a scale with a score range of 0 to 3, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. Total possible score range was 0 to 12 where higher value indicated more cutaneous irritation. | Day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Determined by an Ophthalmologist to Have a Clinically Relevant Positive Outcome for Ocular Irritation After 21 Days of Product Use | The clinically relevant positive outcome for ocular irritation was defined as the number of participants who experienced an increase in total ocular irritation score at Day 21 versus Baseline that was deemed clinically-relevant by the examiner. The ophthalmologist assessment of signs and symptoms of ocular irritation total score was calculated as the sum of the individual ocular response attributes (eczema of the eyelid, conjunctivitis, follicles, and chemosis conjunctivae). Each attribute was assessed on a scale with a score range of 0 to 3, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. Total possible score range was 0 to 12 where higher value indicated the most severe condition. | Day 21 | 
| 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 | Participants were asked to self-assess any sensations of cutaneous discomfort for redness, dryness, stinging/burning, itching, and tightness each on separate 0-3 scale, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. These 5 separate assessments were summed to give an overall self-assessed total signs and symptoms of cutaneous irritation score ranging from 0-15. A high score indicates the most severe condition. Change from Baseline in total score at 1 to 2 hours = total cutaneous score at 1 to 2 hours minus total cutaneous score at Baseline. Negative values reflect improvement; a decrease in total score versus Baseline. This reflects a reduction in total signs and symptoms of cutaneous irritation versus Baseline. Positive values reflect worsening; an increase in total score versus Baseline. This reflects an increase in total signs and symptoms of cutaneous irritation versus Baseline. A zero change reflects no change in total score. | Baseline and 1 to 2 hours post first use | 
| 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 | Participants were asked to self-assess any sensations of cutaneous discomfort for redness, dryness, stinging/burning, itching, and tightness each on separate 0-3 scale, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. These 5 separate assessments were summed to give an overall self-assessed total signs and symptoms of cutaneous irritation score ranging from 0-15. A high score indicates the most severe condition. Change from Baseline in total score at Day 21 = total cutaneous score at Day 21 minus total cutaneous score at Baseline. Negative values reflect improvement; a decrease in total score versus Baseline. This reflects a reduction in total signs and symptoms of cutaneous irritation versus Baseline. Positive values reflect worsening; an increase in total score versus Baseline. This reflects an increase in total signs and symptoms of cutaneous irritation versus Baseline. A zero change reflects no change in total score. | Baseline and Day 21 | 
| 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 | Participants were asked to self-assess any sensations of ocular discomfort for redness, dryness, stinging/burning, and itching each on separate 0-3 scale, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. These 5 separate assessments were summed to give an overall self-assessed total signs and symptoms of ocular discomfort score ranging from 0-12. A high score indicates the most severe condition. Change from Baseline in total score at 1 to 2 hours = total ocular score at 1 to 2 hours minus total ocular score at Baseline. Negative values reflect improvement; a decrease in total score versus Baseline. This reflects a reduction in total signs and symptoms of ocular irritation versus Baseline. Positive values reflect worsening; an increase in total score versus Baseline. This reflects an increase in total signs and symptoms of ocular irritation versus Baseline. A zero change reflects no change in total score. | Baseline and 1 to 2 hours post first use | 
| 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 | Participants were asked to self-assess any sensations of ocular discomfort for redness, dryness, stinging/burning, and itching each on separate 0-3 scale, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. These 5 separate assessments were summed to give an overall self-assessed total signs and symptoms of ocular discomfort score ranging from 0-12. A high score indicates the most severe condition. Change from Baseline in total score at Day 21 = total ocular score at Day 21 minus total ocular score at Baseline. Negative values reflect improvement; a decrease in total score versus Baseline. This reflects a reduction in total signs and symptoms of ocular irritation versus Baseline. Positive values reflect worsening; an increase in total score versus Baseline. This reflects an increase in total signs and symptoms of ocular irritation versus Baseline. A zero change reflects no change in total score. | Baseline and Day 21 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glycerol, Niacinamide, Skin Care