Back to resultsA Clinical Study to Investigate the Dermal and Ocular Tolerance of a Developmental Cosmetic Facial Serum Formulation in Healthy Females With Sensitive Skin
Primary Purpose
Skin Care
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Developmental Serum
Physiogel Calming Relief Anti-Redness Serum
Sponsored by
About this trial
This is an interventional other trial for Skin Care
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) for erythema, edema, scaling or dryness.
- A subject considered immune-compromised.
- A subject currently using any medication which in the opinion of the investigator, may affect the evaluation of the investigational product, or place the subject at undue risk.
- A subject 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 subject who has used oral or topical treatment with vitamin A acid and/or its derivatives up to 1 month before the screening visit.
- A subject who has been vaccinated up to 1 month before the screening visit or who are intending to receive a vaccination during their participation in the study.
- A subject with a recent history (within the last 5 years) of alcohol or other substance abuse.
- A subject 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).
- Subjects with corneal ulcers, keratoconus, blepharitis, meibomitis, pterygium, chemosis,moderately or severe hyperemia or other active ocular diseases.
- A subject who has previously been enrolled in this study.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test product
Reference product
Arm Description
All the participant in this arm will receive the test product (development serum). Test product will be applied twice daily to the freshly cleansed skin in place of the participant's current serum and before applying moisturizer.
All the participant in this arm will receive the reference product (Physiogel Calming Relief Anti-Redness Serum). Reference product will be applied twice daily to the freshly cleansed skin in place of the participant's current serum and before applying moisturizer.
Outcomes
Primary Outcome Measures
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
A qualified dermatologist visually assessed the signs and symptoms of cutaneous irritation for dermal erythema, dryness, scaling, and edema on a scale with a score range of 0 to 3, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. Cutaneous irritation total score = dermal score of erythema + dermal score of dryness + dermal score of scaling + dermal score of edema. Total possible score range is 0 to 12 (higher value indicated more cutaneous irritation). Change from baseline for 21 days of product use = total score at Day 21 minus total score at baseline. Participants with a unit change of greater than (>) 1 in total score (TS) of cutaneous irritation from baseline to 21 days of product use, are reported in this outcome measure.
Secondary Outcome Measures
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
A qualified ophthalmologist visually assessed the signs and symptoms of ocular irritation for ocular eczema of the eyelid, conjunctivitis, follicles and chemosis conjunctivae on a scale with a score range of 0 to 3, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. Ocular irritation total score = ocular score of eczema of the eyelid + ocular score of conjunctivitis + ocular score of follicles + ocular score of chemosis conjunctivae. Total possible score range is 0 to 12 (higher value indicated more ocular irritation). Change from baseline for 21 days of product use = total score at Day 21 minus total score at baseline. Participants with a unit change of > 1 in total score of ocular irritation from baseline to 21 days of product use, are reported in this outcome measure.
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
Participants were instructed to self-assess any sensations of cutaneous discomfort for redness, dryness, stinging/burning, itching and tightness on a scale with a score range of 0 to 3, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. Participant self-assessment of cutaneous irritation total score = redness + dryness + itching + stinging/burning + tightness. Total possible score range is 0 to 15 (higher value indicated more cutaneous irritation). Change from baseline at 1-2 hours post first use = total score at 1 to 2 hours minus total score at baseline. Similarly, change from baseline for 21 days of product use = total score at Day 21 minus total score at baseline. Participants with a unit change of >1 in total score of cutaneous irritation from baseline to 1-2 hours post first product use and 21 days of product use, are reported in this outcome measure.
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
Participants were instructed to self-assess any sensations of ocular discomfort for redness, dryness, stinging/burning and itching on a scale with a score range of 0 to 3, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. Participant self-assessment of ocular irritation total score = redness + dryness + itching + stinging/burning. Total possible score range is 0 to 12 (higher value indicated more ocular irritation). Change from baseline at 1-2 hours post first use = total score at 1 to 2 hours minus total score at baseline. Similarly, change from baseline for 21 days of product use = total score at Day 21 minus total score at baseline. Participants with a change of > 1 in total score of ocular irritation from baseline to 1-2 hours post first product use and Day 21 days of product use, are reported in this outcome measure.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03640832
Brief Title
A Clinical Study to Investigate the Dermal and Ocular Tolerance of a Developmental Cosmetic Facial Serum Formulation in Healthy Females With Sensitive Skin
Official Title
A Clinical Study to Assess the Local Cutaneous and Ocular Tolerance of a Developmental Cosmetic Facial Serum Formulation in Healthy Females With Sensitive Skin
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
November 13, 2018 (Actual)
Study Completion Date
November 13, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
This is a single-center, non-comparative clinical 'in-use' study to determine the local cutaneous and ocular tolerance of a developmental cosmetic facial serum formulation in healthy female subjects aged 18 to 65 years (inclusive) with clinically evaluated sensitive skin, as determined by a positive response to a Lactic Acid Sting Test (LAST), with minimal signs or symptoms of cutaneous irritation and no signs or symptoms of ocular irritation. A reference product, proven to be suitable for use in a sensitive skin population will also be used.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Care
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Evaluator blinded (dermatologist and ophthalmologist).
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test product
Arm Type
Experimental
Arm Description
All the participant in this arm will receive the test product (development serum). Test product will be applied twice daily to the freshly cleansed skin in place of the participant's current serum and before applying moisturizer.
Arm Title
Reference product
Arm Type
Active Comparator
Arm Description
All the participant in this arm will receive the reference product (Physiogel Calming Relief Anti-Redness Serum). Reference product will be applied twice daily to the freshly cleansed skin in place of the participant's current serum and before applying moisturizer.
Intervention Type
Other
Intervention Name(s)
Developmental Serum
Intervention Description
A 30millilitre (mL) bottle with a piston pump will be dispensed to the participants, to be used as a topical dermal (facial) application, twice daily as per normal home use.
Intervention Type
Other
Intervention Name(s)
Physiogel Calming Relief Anti-Redness Serum
Intervention Description
A 30mL bottle with a piston pump will be dispensed to the participants, to be used as a topical dermal (facial) application, twice daily as per normal home use.
Primary Outcome Measure Information:
Title
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
Description
A qualified dermatologist visually assessed the signs and symptoms of cutaneous irritation for dermal erythema, dryness, scaling, and edema on a scale with a score range of 0 to 3, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. Cutaneous irritation total score = dermal score of erythema + dermal score of dryness + dermal score of scaling + dermal score of edema. Total possible score range is 0 to 12 (higher value indicated more cutaneous irritation). Change from baseline for 21 days of product use = total score at Day 21 minus total score at baseline. Participants with a unit change of greater than (>) 1 in total score (TS) of cutaneous irritation from baseline to 21 days of product use, are reported in this outcome measure.
Time Frame
Baseline and Day 21
Secondary Outcome Measure Information:
Title
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
Description
A qualified ophthalmologist visually assessed the signs and symptoms of ocular irritation for ocular eczema of the eyelid, conjunctivitis, follicles and chemosis conjunctivae on a scale with a score range of 0 to 3, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. Ocular irritation total score = ocular score of eczema of the eyelid + ocular score of conjunctivitis + ocular score of follicles + ocular score of chemosis conjunctivae. Total possible score range is 0 to 12 (higher value indicated more ocular irritation). Change from baseline for 21 days of product use = total score at Day 21 minus total score at baseline. Participants with a unit change of > 1 in total score of ocular irritation from baseline to 21 days of product use, are reported in this outcome measure.
Time Frame
Baseline and Day 21
Title
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
Description
Participants were instructed to self-assess any sensations of cutaneous discomfort for redness, dryness, stinging/burning, itching and tightness on a scale with a score range of 0 to 3, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. Participant self-assessment of cutaneous irritation total score = redness + dryness + itching + stinging/burning + tightness. Total possible score range is 0 to 15 (higher value indicated more cutaneous irritation). Change from baseline at 1-2 hours post first use = total score at 1 to 2 hours minus total score at baseline. Similarly, change from baseline for 21 days of product use = total score at Day 21 minus total score at baseline. Participants with a unit change of >1 in total score of cutaneous irritation from baseline to 1-2 hours post first product use and 21 days of product use, are reported in this outcome measure.
Time Frame
Baseline, 1-2 hours post first use, Day 21
Title
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
Description
Participants were instructed to self-assess any sensations of ocular discomfort for redness, dryness, stinging/burning and itching on a scale with a score range of 0 to 3, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. Participant self-assessment of ocular irritation total score = redness + dryness + itching + stinging/burning. Total possible score range is 0 to 12 (higher value indicated more ocular irritation). Change from baseline at 1-2 hours post first use = total score at 1 to 2 hours minus total score at baseline. Similarly, change from baseline for 21 days of product use = total score at Day 21 minus total score at baseline. Participants with a change of > 1 in total score of ocular irritation from baseline to 1-2 hours post first product use and Day 21 days of product use, are reported in this outcome measure.
Time Frame
Baseline, 1-2 hours post first use, Day 21
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female who, at the time of screening, is between the ages of 18 and 65 years, inclusive.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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) for erythema, edema, scaling or dryness.
A subject considered immune-compromised.
A subject currently using any medication which in the opinion of the investigator, may affect the evaluation of the investigational product, or place the subject at undue risk.
A subject 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 subject who has used oral or topical treatment with vitamin A acid and/or its derivatives up to 1 month before the screening visit.
A subject who has been vaccinated up to 1 month before the screening visit or who are intending to receive a vaccination during their participation in the study.
A subject with a recent history (within the last 5 years) of alcohol or other substance abuse.
A subject 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).
Subjects with corneal ulcers, keratoconus, blepharitis, meibomitis, pterygium, chemosis,moderately or severe hyperemia or other active ocular diseases.
A subject who has previously been enrolled in this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Schenefeld
State/Province
Schleswig-Holstein
ZIP/Postal Code
22869
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study is available via the Clinical Study Data Request site.
IPD Sharing Time Frame
IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD Sharing URL
https://www.clinicalstudydatarequest.com/Posting.aspx?ID=20740
Learn more about this trial
A Clinical Study to Investigate the Dermal and Ocular Tolerance of a Developmental Cosmetic Facial Serum Formulation in Healthy Females With Sensitive Skin
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