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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test product | Experimental | 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. |
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| Reference product | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Developmental Serum | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Female who, at the time of screening, is between the ages of 18 and 65 years, inclusive.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Schenefeld | Schleswig-Holstein | 22869 | Germany |
IPD for this study is available via the Clinical Study Data Request site.
IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
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.
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.
All the participants were enrolled from one center in Germany.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Physiogel Calming Relief Anti-redness Serum(Reference Product) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 13, 2018 | Sep 4, 2019 |
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Evaluator blinded (dermatologist and ophthalmologist).
| Physiogel Calming Relief Anti-Redness Serum | Other | 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. |
|
| Baseline and Day 21 |
| 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. | Baseline, 1-2 hours post first use, Day 21 |
| 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. | Baseline, 1-2 hours post first use, Day 21 |
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 |
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| NOT COMPLETED |
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The Safety Population included all participants who received at least 1 dose of the study product (test or reference product).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Fitzpatrick Skin Type | Count of Participants | Participants |
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| Dermatologist Assessment of Signs and Symptoms of Cutaneous Irritation Total Score at Baseline | 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). | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The Safety Population included all participants who received at least 1 dose of the study product (test or reference product). | Posted | Count of Participants | Participants | Baseline and Day 21 |
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| 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. | The Safety Population included all participants who received at least 1 dose of the study product (test or reference product). | Posted | Count of Participants | Participants | Baseline and Day 21 |
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| 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. | The Safety Population included all participants who received at least 1 dose of the study product (test or reference product). | Posted | Count of Participants | Participants | Baseline, 1-2 hours post first use, Day 21 |
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| 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. | The Safety Population included all participants who received at least 1 dose of the study product (test or reference product). | Posted | Count of Participants | Participants | Baseline, 1-2 hours post first use, Day 21 |
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up to 21 (+2) days
The Safety Population included all participants who received at least 1 dose of the study product (test or reference product). Treatment-emergent adverse events (TEAEs) were defined as new adverse events (AEs) that occurred on or after the first product application. One participant might have experienced more than one AE during the study. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 44 | 0 | 44 | 10 | 44 |
| EG001 | 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 | 0 | 46 | 0 | 46 | 7 | 46 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chalazion | Eye disorders | MedDRA vs 4.0 | Systematic Assessment |
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| Eye paraesthesia | Eye disorders | MedDRA vs 4.0 | Systematic Assessment |
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| Eye pruritus | Eye disorders | MedDRA vs 4.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA vs 4.0 | Systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | MedDRA vs 4.0 | Systematic Assessment |
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| Jaw cyst | Musculoskeletal and connective tissue disorders | MedDRA vs 4.0 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA vs 4.0 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA vs 4.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA vs 4.0 | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA vs 4.0 | Systematic Assessment |
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| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA vs 4.0 | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA vs 4.0 | Systematic Assessment |
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| Rash macular | Skin and subcutaneous tissue disorders | MedDRA vs 4.0 | Systematic Assessment |
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| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA vs 4.0 | Systematic Assessment |
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| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA vs 4.0 | Systematic Assessment |
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GSK agreements may vary with individual investigators but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 21, 2018 | Sep 4, 2019 | SAP_001.pdf |
| Male |
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| White - White/Caucasian/European heritage |
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| Unknown or not reported |
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| II - white skin |
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| III - light brown skin |
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| IV - moderate brown skin |
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| Baseline, TS= 1.5 |
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| Baseline, TS= 2 |
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| Baseline, TS= 2.5 |
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| Baseline, TS= 3 |
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| Baseline, TS= 3.5 |
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| Baseline, TS= 4 |
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| Baseline, TS= 4.5 |
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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
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| 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 |
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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 |
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