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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Developmental Serum | Experimental | 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. |
|
| Developmental Lotion | Experimental | The participants will apply a developmental lotion topically to the face twice daily (morning and evening) to freshly cleansed skin for 21 days. |
|
| Developmental Cream | Experimental | The participants will apply a developmental cream topically to the face twice daily (morning and evening) to freshly cleansed skin for 21 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serum | Other | Participants will topically apply the serum to the face as per normal home use application in place of their current facial serum product. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Schenefeld | Schleswig-Holstein | 22869 | Germany |
IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
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.
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A total of 286 participants were screened of which 150 participants were enrolled and allocated to a randomized treatment. A total of 147 participants completed the study.
The study was conducted at single center in Germany.
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| ID | Title | Description |
|---|---|---|
| FG000 | Developmental Serum | The first topical application of the developmental serum was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental serum at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental serum was performed at home on the morning of the final visit. |
| FG001 | Developmental Lotion | The first topical application of the developmental lotion was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental lotion at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental lotion was performed at home on the morning of the final visit. |
| FG002 | Developmental Cream | The first topical application of the developmental cream was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental cream at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental cream was performed at home on the morning of the final visit. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Population comprised of all randomized participants who had at least one application of the study product (serum, lotion, or cream)
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| ID | Title | Description |
|---|---|---|
| BG000 | Developmental Serum | The first topical application of the developmental serum was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental serum at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental serum was performed at home on the morning of the final visit. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 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. | Safety Population | Posted | Count of Participants | Participants | Day 21 |
|
From Screening up to Final Visit (Day 21)
Treatment-emergent Adverse Events (TEAEs) were defined as new Adverse Events (AEs) that occurred on or after the first study product application (if this date was missing, a suitable alternative was used). AEs with an onset date/time prior to the first study product application were considered as non-treatment emergent.
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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 Serum | The first topical application of the developmental serum was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental serum at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental serum was performed at home on the morning of the final visit. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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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 | Mar 10, 2020 | Dec 15, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 18, 2020 | Dec 15, 2021 | SAP_001.pdf |
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The study is a randomized, 3-arm parallel group study.
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Evaluator-blind
| Lotion | Other | Participants will topically apply lotion to the face as per normal home use application in place of their current facial lotion product. |
|
| Cream | Other | Participants will topically apply cream to the face as per normal home use application in place of their current facial cream product. |
|
| 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 |
| Adverse Event |
|
| BG001 | Developmental Lotion | The first topical application of the developmental lotion was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental lotion at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental lotion was performed at home on the morning of the final visit. |
| BG002 | Developmental Cream | The first topical application of the developmental cream was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental cream at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental cream was performed at home on the morning of the final visit. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
The first topical application of the developmental serum was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental serum at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental serum was performed at home on the morning of the final visit.
| OG001 | Developmental Lotion | The first topical application of the developmental lotion was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental lotion at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental lotion was performed at home on the morning of the final visit. |
| OG002 | Developmental Cream | The first topical application of the developmental cream was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental cream at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental cream was performed at home on the morning of the final visit. |
|
|
| Secondary | 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. | Safety Population | Posted | Count of Participants | Participants | Day 21 |
|
|
|
| Secondary | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application | 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. | Safety Population. | Posted | Count of Participants | Participants | Baseline and 1 to 2 hours post first use |
|
|
|
| Secondary | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Count of Participants | Participants | Baseline and Day 21 |
|
|
|
| Secondary | Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application | 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. | Safety Population | Posted | Count of Participants | Participants | Baseline and 1 to 2 hours post first use |
|
|
|
| Secondary | Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use | 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. | Safety Population. Only those participants with data available at the specified time points were analyzed. | Posted | Count of Participants | Participants | Baseline and Day 21 |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 5 |
| 50 |
| EG001 | Developmental Lotion | The first topical application of the developmental lotion was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental lotion at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental lotion was performed at home on the morning of the final visit. | 0 | 49 | 0 | 49 | 6 | 49 |
| EG002 | Developmental Cream | The first topical application of the developmental cream was applied by the participants at the study site under the supervision of a trained technician. Participants were instructed to apply developmental cream at home again the same evening of their first supervised application and then twice daily for a total of 21 days, as part of their normal skin care routine. The final application of developmental cream was performed at home on the morning of the final visit. | 0 | 51 | 0 | 51 | 4 | 51 |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Systematic Assessment |
|
| Papule | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Systematic Assessment |
|
| Skin oedema | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
|
| Conjunctivitis bacterial | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
|
| NASAL MUCOSAL DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
|
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
|
| EYE IRRITATION | Eye disorders | MedDRA version 23.1 | Systematic Assessment |
|
| DYSMENORRHOEA | Reproductive system and breast disorders | MedDRA version 23.1 | Systematic Assessment |
|
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 | Measurements |
|---|---|
|
| Total score= -9 |
|
| Total score= -8.5 |
|
| Total score= -8 |
|
| Total score= -7.5 |
|
| Total score= -7 |
|
| Total score= -6 |
|
| Total score= -5.5 |
|
| Total score= -5 |
|
| Total score= -4.5 |
|
| Total score= -4 |
|
| Total score= -3.5 |
|
| Total score= -3 |
|
| Total score= -2.5 |
|
| Total score= -2 |
|
| Total score= -1.5 |
|
| Total score= -1 |
|
| Total score= -0.5 |
|
| Total score= 0 |
|
| Total score= 0.5 |
|
| Total score= 2 |
|
| Total score= 3 |
|
| Title | Measurements |
|---|---|
|
| Total score= -10 |
|
| Total score= -9 |
|
| Total score= -8.5 |
|
| Total score= -8 |
|
| Total score= -7.5 |
|
| Total score= -6.5 |
|
| Total score= -6 |
|
| Total score= -5.5 |
|
| Total score= -5 |
|
| Total score= -4.5 |
|
| Total score= -4 |
|
| Total score= -3.5 |
|
| Total score= -3 |
|
| Total score= -2.5 |
|
| Total score= -2 |
|
| Total score= -1.5 |
|
| Total score= -1 |
|
| Total score= -0.5 |
|
| Total score= 0 |
|
| Total score= 0.5 |
|
| Total score= 1 |
|
| Total score= 2 |
|
| Title | Measurements |
|---|---|
|
| Total score= -2 |
|
| Total score= -1.5 |
|
| Total score= -1 |
|
| Total score= -0.5 |
|
| Total score= 0 |
|
| Total score= 0.5 |
|
| Total score= 1 |
|
| Title | Measurements |
|---|---|
|
| Total score= -2.5 |
|
| Total score= -2 |
|
| Total score= -1.5 |
|
| Total score= -1 |
|
| Total score= -0.5 |
|
| Total score= 0 |
|
| Total score= 0.5 |
|
| Total score= 1 |
|
| Total score= 1.5 |
|
| Total score= 2.5 |
|
| Total score= 3 |
|
| Total score= 4.5 |
|
| Total score= 6 |
|