Skin Care
Conditions
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.
Interventions
OTHERDevelopmental Serum
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.
OTHERPhysiogel Calming Relief Anti-Redness Serum
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.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
Evaluator blinded (dermatologist and ophthalmologist).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline and Day 21 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline and Day 21 | 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 | Baseline, 1-2 hours post first use, Day 21 | 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 | Baseline, 1-2 hours post first use, Day 21 | 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. |
Countries
Germany
Participant flow
Recruitment details
All the participants were enrolled from one center in Germany.
Pre-assignment details
A total of 141 participants were screened for the study out of which 90 participants were enrolled and randomized to any of the 2 treatment arms. A total of 51 participants did not meet the study criteria and were not randomized. All 90 randomized participants completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Developmental Facial Serum (Test Product) Participants were randomized to topically (facial) apply Physiogel Developmental Facial Serum, twice daily (morning and evening) to the freshly cleansed skin before applying moisturizer up to 21 (+2) days | 44 |
| Physiogel Calming Relief Anti-redness Serum(Reference Product) Participants were randomized to topically (facial) apply Physiogel Calming Relief Anti-Redness Serum, twice daily (morning and evening) to the freshly cleansed skin before applying moisturizer up to 21 (+2) days | 46 |
| Total | 90 |
Baseline characteristics
| Characteristic | Developmental Facial Serum (Test Product) | Total | Physiogel Calming Relief Anti-redness Serum(Reference Product) |
|---|---|---|---|
| Age, Continuous | 49.5 Years STANDARD_DEVIATION 10.05 | 49.2 Years STANDARD_DEVIATION 10.95 | 48.8 Years STANDARD_DEVIATION 11.84 |
| Dermatologist Assessment of Signs and Symptoms of Cutaneous Irritation Total Score at Baseline Baseline, total score(TS)= 1 | 11 Participants | 25 Participants | 14 Participants |
| Dermatologist Assessment of Signs and Symptoms of Cutaneous Irritation Total Score at Baseline Baseline, TS= 1.5 | 16 Participants | 28 Participants | 12 Participants |
| Dermatologist Assessment of Signs and Symptoms of Cutaneous Irritation Total Score at Baseline Baseline, TS= 2 | 7 Participants | 10 Participants | 3 Participants |
| Dermatologist Assessment of Signs and Symptoms of Cutaneous Irritation Total Score at Baseline Baseline, TS= 2.5 | 1 Participants | 7 Participants | 6 Participants |
| Dermatologist Assessment of Signs and Symptoms of Cutaneous Irritation Total Score at Baseline Baseline, TS= 3 | 5 Participants | 11 Participants | 6 Participants |
| Dermatologist Assessment of Signs and Symptoms of Cutaneous Irritation Total Score at Baseline Baseline, TS= 3.5 | 1 Participants | 2 Participants | 1 Participants |
| Dermatologist Assessment of Signs and Symptoms of Cutaneous Irritation Total Score at Baseline Baseline, TS= 4 | 2 Participants | 6 Participants | 4 Participants |
| Dermatologist Assessment of Signs and Symptoms of Cutaneous Irritation Total Score at Baseline Baseline, TS= 4.5 | 1 Participants | 1 Participants | 0 Participants |
| Fitzpatrick Skin Type III - light brown skin | 22 Participants | 39 Participants | 17 Participants |
| Fitzpatrick Skin Type II - white skin | 13 Participants | 36 Participants | 23 Participants |
| Fitzpatrick Skin Type I - pale white skin | 6 Participants | 10 Participants | 4 Participants |
| Fitzpatrick Skin Type IV - moderate brown skin | 3 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian - South East Asian heritage | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown or not reported | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European heritage | 43 Participants | 87 Participants | 44 Participants |
| Sex: Female, Male Female | 44 Participants | 90 Participants | 46 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 46 |
| other Total, other adverse events | 10 / 44 | 7 / 46 |
| serious Total, serious adverse events | 0 / 44 | 0 / 46 |
Outcome results
Primary
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.
Time frame: Baseline and Day 21
Population: The Safety Population included all participants who received at least 1 dose of the study product (test or reference product).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Developmental Facial Serum (Test Product) | 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 | 3 Participants |
| Physiogel Calming Relief Anti-redness Serum(Reference Product) | 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 | 0 Participants |
Secondary
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.
Time frame: Baseline, 1-2 hours post first use, Day 21
Population: The Safety Population included all participants who received at least 1 dose of the study product (test or reference product).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Developmental Facial Serum (Test Product) | 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 | Baseline, TS= 1 | 3 Participants |
| Developmental Facial Serum (Test Product) | 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 | Baseline, TS= 1.5 | 1 Participants |
| Developmental Facial Serum (Test Product) | 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 | Baseline, TS= 2 | 3 Participants |
| Developmental Facial Serum (Test Product) | 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 | Baseline, TS= 2.5 | 2 Participants |
| Developmental Facial Serum (Test Product) | 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 | Baseline, TS= 3 | 8 Participants |
| Developmental Facial Serum (Test Product) | 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 | Baseline, TS= 3.5 | 1 Participants |
| Developmental Facial Serum (Test Product) | 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 | Baseline, TS= 4 | 6 Participants |
| Developmental Facial Serum (Test Product) | 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 | Baseline, TS= 4.5 | 4 Participants |
| Developmental Facial Serum (Test Product) | 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 | Baseline, TS= 5 | 5 Participants |
| Developmental Facial Serum (Test Product) | 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 | Baseline, TS= 5.5 | 1 Participants |
| Developmental Facial Serum (Test Product) | 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 | Baseline, TS= 6 | 3 Participants |
| Developmental Facial Serum (Test Product) | 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 | Baseline, TS= 6.5 | 0 Participants |
| Developmental Facial Serum (Test Product) | 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 | Baseline, TS= 7 | 0 Participants |
| Developmental Facial Serum (Test Product) | 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 | Baseline, TS= 7.5 | 1 Participants |
| Developmental Facial Serum (Test Product) | 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 | Baseline, TS= 8 | 1 Participants |
| Developmental Facial Serum (Test Product) | 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 | Baseline, TS= 9 | 2 Participants |
| Developmental Facial Serum (Test Product) | 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 | Baseline, TS= 10 | 2 Participants |
| Developmental Facial Serum (Test Product) | 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 | Baseline, TS= 12 | 1 Participants |
| Developmental Facial Serum (Test Product) | 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 | Change at 1-2 hours, TS >1 | 3 Participants |
| Developmental Facial Serum (Test Product) | 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 | Change at Day 21, TS >1 | 3 Participants |
| Physiogel Calming Relief Anti-redness Serum(Reference Product) | 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 | Baseline, TS= 12 | 0 Participants |
| Physiogel Calming Relief Anti-redness Serum(Reference Product) | 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 | Baseline, TS= 1 | 1 Participants |
| Physiogel Calming Relief Anti-redness Serum(Reference Product) | 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 | Baseline, TS= 6 | 2 Participants |
| Physiogel Calming Relief Anti-redness Serum(Reference Product) | 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 | Baseline, TS= 1.5 | 4 Participants |
| Physiogel Calming Relief Anti-redness Serum(Reference Product) | 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 | Baseline, TS= 9 | 1 Participants |
| Physiogel Calming Relief Anti-redness Serum(Reference Product) | 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 | Baseline, TS= 2 | 4 Participants |
| Physiogel Calming Relief Anti-redness Serum(Reference Product) | 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 | Baseline, TS= 6.5 | 2 Participants |
| Physiogel Calming Relief Anti-redness Serum(Reference Product) | 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 | Baseline, TS= 2.5 | 6 Participants |
| Physiogel Calming Relief Anti-redness Serum(Reference Product) | 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 | Change at Day 21, TS >1 | 1 Participants |
| Physiogel Calming Relief Anti-redness Serum(Reference Product) | 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 | Baseline, TS= 3 | 2 Participants |
| Physiogel Calming Relief Anti-redness Serum(Reference Product) | 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 | Baseline, TS= 7 | 2 Participants |
| Physiogel Calming Relief Anti-redness Serum(Reference Product) | 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 | Baseline, TS= 3.5 | 3 Participants |
| Physiogel Calming Relief Anti-redness Serum(Reference Product) | 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 | Baseline, TS= 10 | 0 Participants |
| Physiogel Calming Relief Anti-redness Serum(Reference Product) | 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 | Baseline, TS= 4 | 9 Participants |
| Physiogel Calming Relief Anti-redness Serum(Reference Product) | 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 | Baseline, TS= 7.5 | 0 Participants |
| Physiogel Calming Relief Anti-redness Serum(Reference Product) | 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 | Baseline, TS= 4.5 | 3 Participants |
| Physiogel Calming Relief Anti-redness Serum(Reference Product) | 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 | Change at 1-2 hours, TS >1 | 4 Participants |
| Physiogel Calming Relief Anti-redness Serum(Reference Product) | 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 | Baseline, TS= 5 | 4 Participants |
| Physiogel Calming Relief Anti-redness Serum(Reference Product) | 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 | Baseline, TS= 8 | 3 Participants |
| Physiogel Calming Relief Anti-redness Serum(Reference Product) | 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 | Baseline, TS= 5.5 | 0 Participants |
Secondary
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.
Time frame: Baseline, 1-2 hours post first use, Day 21
Population: The Safety Population included all participants who received at least 1 dose of the study product (test or reference product).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Developmental Facial Serum (Test Product) | 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 | Baseline, TS= 1.5 | 4 Participants |
| Developmental Facial Serum (Test Product) | 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 | Baseline, TS= 4 | 1 Participants |
| Developmental Facial Serum (Test Product) | 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 | Baseline, TS= 1 | 3 Participants |
| Developmental Facial Serum (Test Product) | 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 | Baseline, TS= 6 | 1 Participants |
| Developmental Facial Serum (Test Product) | 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 | Baseline, TS= 2 | 1 Participants |
| Developmental Facial Serum (Test Product) | 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 | Baseline, TS= 6.5 | 0 Participants |
| Developmental Facial Serum (Test Product) | 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 | Baseline, TS= 0.5 | 10 Participants |
| Developmental Facial Serum (Test Product) | 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 | Change at 1-2 hours, TS >1 | 0 Participants |
| Developmental Facial Serum (Test Product) | 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 | Baseline, TS= 2.5 | 1 Participants |
| Developmental Facial Serum (Test Product) | 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 | Change at Day 21, TS >1 | 1 Participants |
| Developmental Facial Serum (Test Product) | 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 | Baseline, TS= 0 | 23 Participants |
| Physiogel Calming Relief Anti-redness Serum(Reference Product) | 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 | Change at Day 21, TS >1 | 1 Participants |
| Physiogel Calming Relief Anti-redness Serum(Reference Product) | 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 | Baseline, TS= 0 | 22 Participants |
| Physiogel Calming Relief Anti-redness Serum(Reference Product) | 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 | Baseline, TS= 0.5 | 6 Participants |
| Physiogel Calming Relief Anti-redness Serum(Reference Product) | 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 | Baseline, TS= 1 | 8 Participants |
| Physiogel Calming Relief Anti-redness Serum(Reference Product) | 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 | Baseline, TS= 1.5 | 5 Participants |
| Physiogel Calming Relief Anti-redness Serum(Reference Product) | 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 | Baseline, TS= 2 | 3 Participants |
| Physiogel Calming Relief Anti-redness Serum(Reference Product) | 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 | Baseline, TS= 2.5 | 1 Participants |
| Physiogel Calming Relief Anti-redness Serum(Reference Product) | 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 | Baseline, TS= 4 | 0 Participants |
| Physiogel Calming Relief Anti-redness Serum(Reference Product) | 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 | Baseline, TS= 6 | 0 Participants |
| Physiogel Calming Relief Anti-redness Serum(Reference Product) | 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 | Baseline, TS= 6.5 | 1 Participants |
| Physiogel Calming Relief Anti-redness Serum(Reference Product) | 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 | Change at 1-2 hours, TS >1 | 0 Participants |
Secondary
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.
Time frame: Baseline and Day 21
Population: The Safety Population included all participants who received at least 1 dose of the study product (test or reference product).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Developmental Facial Serum (Test Product) | 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 | Baseline, TS= 0 | 44 Participants |
| Developmental Facial Serum (Test Product) | 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 | Change at Day 21, TS >1 | 1 Participants |
| Physiogel Calming Relief Anti-redness Serum(Reference Product) | 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 | Baseline, TS= 0 | 46 Participants |
| Physiogel Calming Relief Anti-redness Serum(Reference Product) | 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 | Change at Day 21, TS >1 | 0 Participants |