To Evaluate the Effect of Moisturizing Creams on Skin Barrier Function

A Clinical Study to Investigate the Effects of Two Developmental Cosmetic Moisturizing Cream Formulations on the Barrier Function of Human Skin on the Face and Legs

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03804710

Enrollment

158

Registered

2019-01-15

Start date

2019-01-22

Completion date

2019-04-16

Last updated

2020-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Skin, Skin Care

Keywords

Skin care, Moisturizing Cream

Brief summary

The aim of this study is to evaluate the impact of twice-daily topical application of two different moisturizing creams on skin barrier function for 4 weeks.

Detailed description

This study will be a randomized, evaluator-blind, single-center, two-treatment regimen, controlled, parallel-group, with a treatment period of 4 weeks. The study will assess the skin barrier function of the two-treatment regimen in healthy participants with dry, sensitive skin on the face and lower legs. All participants will be centrally randomized to one of the 2 treatment groups using an Interactive Response Technology (IRT).

Interventions

DRUGDevelopmental moisturizing cream 1

Participants will topically apply developmental moisturizing cream 1

DRUGDevelopmental moisturizing cream 2

Participants will topically apply developmental moisturizing cream 2

OTHERStandard cleanser soap

Participants will cleanse the entire face and both lower legs (between the knees and the ankles)with simple pure soap

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

1. Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed. 2. A participant who is willing and able to comply with scheduled visits, the product application schedule, the Lifestyle Considerations, and other study procedures which includes: a) to remove facial make-up at the screening visit to allow visual assessments; b) using other skin-care products is not permitted including but not limited to: leave-on cosmetics, moisturizers, lotions, creams, sunscreens, soaps, cleansing, exfoliation products, etc. on their face or legs, other than the standard soap and study product(s) provided; c) at all post baseline study visit days, participants must cleanse their face and legs with the standard soap and then apply the test product (s) approximately 10-16 hours before each study appointment (i.e. evening before); d) no use of any product on the face or legs, including the standard soap and test product, within 10 hours of all instrumental measurements on visit days (no showering/bathing permitted with soaps/shampoo within this period) will be permitted. 3. A participant 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 examination, or condition, that would impact the participant'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. 4. A participant who responds Yes to the following question: Do you consider yourself to have dry, sensitive skin on your face and very dry skin on your legs? 5. A participant with an overall dryness assessment total score of ≥3 for each side of the face at screening visit (Visit 1) and baseline visit (Visit 2). With no more than 0.5-unit score difference between each side of the face. Including an examiner score of at ≥ 1 (slight) for the roughness parameter. 6. A participant with an overall dryness assessment total score of ≥6 for each leg at screening visit (Visit 1) and baseline visit (Visit 2). With no more than 1-unit score difference between each leg. 7. A participant with a Fitzpatrick skin type I-IV.

Exclusion criteria

1. A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their 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. 2. A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation. 3. A participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product application or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study. 4. A female participant who is pregnant (self-reported) or intending to become pregnant. 5. A female participant who is breastfeeding. 6. A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. 7. A participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study. 8. A participant with current or recent (within 6 months before the start of the study) history of atopic lesions and/or eczema. 9. A participant with a history of allergic reactions to topical-use products, cosmetics or medications or their ingredients. 10. A participant with any history of significant diseases or medical conditions known to alter skin or eye appearance or physiologic response (e.g. Type 2 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. 11. A participant presenting open sores, pimples, or cysts at the application site (face or lower legs). 12. A participant with an active dermatosis (local or disseminated) that might interfere with the results of the study. 13. A participant currently using any medication which in the opinion of the investigator, may affect the evaluation of the investigational product, or place the participant at undue risk 14. A participant who has used any of the following topical or systemic medications up to 1 month before the screening visit or intends to use during the study period: immuno-suppressants, antihistamines, non-steroidal anti-inflammatory drugs (NSAIDS), and corticosteroids. 15. A participant who has used oral or topical treatment with vitamin A acid and/or its derivatives up to 1 month before the screening visit or intends to use during the study period. 16. A participant who intends to use any topical drug or medication on the proposed application areas. A participant who has been vaccinated up to 1 month before the screening visit or is intending to receive a vaccination during their participation in the study. 18\. A participant currently receiving allergy injections, or received an allergy injection within 7 days prior to Visit 1, or expects to begin injections during study participation 19. A participant with a recent history (within the last 5 years) of alcohol or other substance abuse. 20\. A participant with any skin marks on the face or lower legs that might interfere with the evaluation of possible skin reactions (e.g. pigmentation disorders, vascular malformations, scars, tattoos, excessive hair, numerous freckles). 21. Participants with corneal ulcers, keratoconus, blepharitis, meibomitis, pterygium, chemosis, moderately or severe hyperemia or other active ocular diseases. 22. A participant who has previously been enrolled in this study. 23. A participant who is unwilling to abstain from smoking tobacco or using any other nicotine containing products. 24\. A participant with visible sunburn on any of the test sites. 25. A participant with moles, tattoos, scars, hairs, etc. at the test areas if it is likely that they could affect the assessments. 26. A participant who has used self-tanning products on the test areas (face and arms) within 2 weeks prior to the screening visit. 27. A participant who intends to expose their skin to natural or artificial ultraviolet (UV) light (e.g. sunbathing or tanning beds). 28. A participant with any participant self-assessed or dermatologist dryness parameter score 4 (very severe) on the test areas of the lower legs or face. 29\. Any participant who, in the judgment of the Investigator, should not participate in the study.

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in Trans-epidermal Water Loss (TEWL) Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 29	Baseline and Day 29	TEWL was measured using the Tewameter TM 300. TEWL is a non-invasive method to measure the integrity of stratum corneum barrier function. Tewameter probe measures the density gradient of the water evaporation from the skin indirectly by two pairs of sensors (temperature and relative humidity) inside a hollow cylinder. The probe was held in place on the skin for one measurement, for 40 sec, to ensure that a stable value has been established. The values of the last 10 sec are averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function. TEWL was measured at area 1 (right face) and 2 (left face) at baseline visit (Visit 2) prior to any study product application and then measured throughout the study period per the study schedule. Change from baseline was calculated as the value at specified visit (Visit 5/Day 29) minus the baseline value.

Secondary

Measure	Time frame	Description
Change From Baseline in TEWL Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 15	Baseline and Day 15	TEWL was measured using the Tewameter TM 300. TEWL is a non-invasive method to measure the integrity of stratum corneum barrier function. Tewameter probe measures the density gradient of the water evaporation from the skin indirectly by two pairs of sensors (temperature and relative humidity) inside a hollow cylinder. The probe was held in place on the skin for one measurement, for 40 sec, to ensure that a stable value has been established. The values of the last 10 sec are averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function. TEWL was measured at area 1 (right face) and 2 (left face) at baseline visit (Visit 2) prior to any study product application and then measured throughout the study period per the study schedule. Change from baseline was calculated as the value at specified visit (Visit 5/Day 29) minus the baseline value (Visit 2).
Change From Baseline in TEWL Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 15	Baseline and Day 15	TEWL was measured using the Tewameter TM 300. TEWL is a non-invasive method to measure the integrity of stratum corneum barrier function. Tewameter probe measures the density gradient of the water evaporation from the skin indirectly by two pairs of sensors (temperature and relative humidity) inside a hollow cylinder. The probe was held in place on the skin for one measurement, for 40 sec, to ensure that a stable value has been established. The values of the last 10 sec are averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function. TEWL was measured at area 5 (right leg) and 6 (left leg) at baseline visit (Visit 2) prior to any study product application and then measured throughout the study period per the study schedule. Change from baseline was calculated as the value at specified visit (Visit 5/Day 29) minus the baseline value (Visit 2).
Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Two Different Time-points [30 Minutes (Mins) and 6 Hrs After First Application] at Day 1 and One Time-point at Day 2	Baseline, 30 mins and 6 hrs after first treatment application on Day 1 and 24 hrs after treatment application on Day 2	Stratum corneum (SC) moisturization measured using the Corneometer CM 825. The measuring principle is based on changes in the capacitance of the measuring head, functioning as condensator. The electric field was created between gold conductors to enable the dielectricity of the SC to be measured. Because the dielectricity varies as a function of the skin's water content, the SC moisturization was measured. Corneometer probe was placed in contact with the skin of the participants test site for 1 to 2 sec per measurement. The measurement will be taken 5 times in total and then an average reading will be calculated for each site and time point. The Corneometer values lower than 30 international units (i.u) represent very dry skin and values between 30 to 50 i.u represent dry skin on the forearm. Higher value of Corneometer indicates high moisture content. The area 1 (right face) and area 2 (left face) were considered.
Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Two Different Time-points (30 Mins and 6 Hrs After First Application) at Day 1 and One Time-point at Day 2	Baseline, Day 1 and Day 2	SC moisturization measured using the Corneometer CM 825. The measuring principle is based on changes in the capacitance of the measuring head, functioning as condensator. The electric field was created between gold conductors to enable the dielectricity of the SC to be measured. Because the dielectricity varies as a function of the skin's water content, the SC moisturization was measured. Corneometer probe was placed in contact with the skin of the participants test site for 1 to 2 sec per measurement. The measurement will be taken 5 times in total and then an average reading will be calculated for each site and time point. The Corneometer values lower than 30 i.u represent very dry skin and values between 30 to 50 i.u represent dry skin on the forearm. Higher value of Corneometer indicates high moisture content. The area 5 (right leg) and area 6 (left leg) were considered.
Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 15 and 29	Baseline, Day 15 and 29	SC moisturization measured using the Corneometer CM 825. The measuring principle is based on changes in the capacitance of the measuring head, functioning as condensator. The electric field was created between gold conductors to enable the dielectricity of the SC to be measured. Because the dielectricity varies as a function of the skin's water content, the SC moisturization was measured. Corneometer probe was placed in contact with the skin of the participants test site for 1 to 2 sec per measurement. The measurement will be taken 5 times in total and then an average reading will be calculated for each site and time point. The Corneometer values lower than 30 i.u represent very dry skin and values between 30 to 50 i.u represent dry skin on the forearm. Higher value of Corneometer indicates high moisture content. The area 1 (right face) and area 2 (left face) were considered.
Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 15 and 29	Baseline, Day 15 and Day 29	SC moisturization measured using the Corneometer CM 825. The measuring principle is based on changes in the capacitance of the measuring head, functioning as condensator. The electric field was created between gold conductors to enable the dielectricity of the SC to be measured. Because the dielectricity varies as a function of the skin's water content, the SC moisturization was measured. Corneometer probe was placed in contact with the skin of the participants test site for 1 to 2 sec per measurement. The measurement will be taken 5 times in total and then an average reading will be calculated for each site and time point. The Corneometer values lower than 30 i.u represent very dry skin and values between 30 to 50 i.u represent dry skin on the forearm. Higher value of Corneometer indicates high moisture content. The area 5 (right leg) and area 6 (left leg) were considered.
Change From Baseline in TEWL Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 30, 31, 32, 33 and 34	Baseline, Day 30, 31, 32, 33 and 34	TEWL was measured using the Tewameter TM 300. TEWL is a non-invasive method to measure the integrity of stratum corneum barrier function. Tewameter probe measures the density gradient of the water evaporation from the skin indirectly by two pairs of sensors (temperature and relative humidity) inside a hollow cylinder. The probe was held in place on the skin for one measurement, for 40 sec, to ensure that a stable value has been established. The values of the last 10 sec are averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function. TEWL was measured at area 1 (right face) and 2 (left face) at baseline visit (Visit 2) prior to any study product application and then measured throughout the study period per the study schedule. Change from baseline was calculated as the value at specified visit (Visit 5/Day 29) minus the baseline value.
Change From Baseline in TEWL Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 29	Baseline and Day 29	TEWL was measured using the Tewameter TM 300. TEWL is a non-invasive method to measure the integrity of stratum corneum barrier function. Tewameter probe measures the density gradient of the water evaporation from the skin indirectly by two pairs of sensors (temperature and relative humidity) inside a hollow cylinder. The probe was held in place on the skin for one measurement, for 40 sec, to ensure that a stable value has been established. The values of the last 10 sec are averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function. TEWL was measured at area 5 (right leg) and 6 (left leg) at baseline visit (Visit 2) prior to any study product application and then measured throughout the study period per the study schedule. Change from baseline was calculated as the value at specified visit (Visit 5/Day 29) minus the baseline value (Visit 2).
Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 30, 31, 32, 33 and 34	Baseline, Day 30, 31, 32, 33 and 34	SC moisturization measured using the Corneometer CM 825. The measuring principle is based on changes in the capacitance of the measuring head, functioning as condensator. The electric field was created between gold conductors to enable the dielectricity of the SC to be measured. Because the dielectricity varies as a function of the skin's water content, the SC moisturization was measured. Corneometer probe was placed in contact with the skin of the participants test site for 1 to 2 sec per measurement. The measurement will be taken 5 times in total and then an average reading will be calculated for each site and time point. The Corneometer values lower than 30 i.u represent very dry skin and values between 30 to 50 i.u represent dry skin on the forearm. Higher value of Corneometer indicates high moisture content. The area 1 (right face) and area 2 (left face) were considered.
Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 30, 31, 32, 33 and 34	Baseline, Day 30, 31, 32, 33 and 34	SC moisturization measured using the Corneometer CM 825. The measuring principle is based on changes in the capacitance of the measuring head, functioning as condensator. The electric field was created between gold conductors to enable the dielectricity of the SC to be measured. Because the dielectricity varies as a function of the skin's water content, the SC moisturization was measured. Corneometer probe was placed in contact with the skin of the participants test site for 1 to 2 sec per measurement. The measurement will be taken 5 times in total and then an average reading will be calculated for each site and time point. The Corneometer values lower than 30 i.u represent very dry skin and values between 30 to 50 i.u represent dry skin on the forearm. Higher value of Corneometer indicates high moisture content. The area 5 (right leg) and area 6 (left leg) were considered.
Change From Pre-challenge in TEWL Following Application of Test Regimen on Face (Area 3 Compared to Area 4) at 3 Different Time Points of Strips Removal (3,6 and 9) at Day 29	Day 31	Tape-stripping method was used to evaluate the impact of physical challenge to the skin barrier after product use. Stripping challenge was performed on D-Squame sites on area 3 (right face) and area 4 (left face) at Day 29 by sequential application and removal of D-Squame adhesive 3, 6, and 9 discs. A Series of D-Squame discs were applied over the areas with uniform pressure for 5 sec with a stamp to ensure consistent adhesion to the skin. The disc was pulled off the skin with one fluent and decisive movement. TEWL was measured pre-challenge and after 3, 6, and 9 discs had been removed. TEWL was measured using the Tewameter TM 300. Tewameter probe measures the density gradient of the water evaporation from the skin indirectly by two pairs of sensors (temperature and relative humidity) inside a hollow cylinder. TEWL measurement was taken in triplicate. The average reading was considered for each area and time point. An increase in TEWL values shows damage to the skin barrier function.
Change From Pre-challenge in TEWL Following Application of Test Regimen on Legs (Area 7 Compared to Area 8) at 3 Different Time Points of Strips Removal (4, 8 and 12) at Day 29	Pre-challenge and Day 29	Tape-stripping method was used to evaluate the impact of a physical challenge to the skin barrier after product use. Stripping challenge was performed on D-Squame sites on area 3 (right face) and area 4 (left face) at Day 29 by sequential application and removal of D-Squame adhesive 3, 6, and 9 discs. A Series of D-Squame discs were applied over the areas with uniform pressure for 5 sec with a stamp to ensure consistent adhesion to the skin. The disc was pulled off the skin with one fluent and decisive movement. TEWL was measured pre-challenge after 3, 6, and 9 discs have been removed. TEWL was measured using the Tewameter TM 300. Tewameter probe measures the density gradient of the water evaporation from the skin indirectly by two pairs of sensors (temperature and relative humidity) inside a hollow cylinder. TEWL measurement was taken in triplicate. The average reading was considered for each area and time point. An increase in TEWL values shows damage to the skin barrier function.
Total Protein Content Extracted From D-Squame Discs From a Total of 9 Adhesive Discs on Face (Area 3 Compared to Area 4) at Day 29	Day 29	Total protein content was measured using the SquameScan 850. SquameScan 850 is an instrument used to measure the protein content extracted from the skin by D-Squame tape strips. The determination is carried out by measuring the optical absorption of the strip at 850 nanometers (nm). Value displayed in percentage (%) was proportionally related to protein content. An 18 D-Squame discs were taken from participant (two sets of 9 discs from each side of the face). The protein content was analyzed for each of the discs obtained from the D-Squame stripping on area 3 (right face) and area 4 (left face) on Day 29.
Total Protein Content Extracted From D-Squame Discs From a Total of 12 Adhesive Discs on Leg (Area 7 Compared to Area 8) at Day 29	Day 29	Total protein content was measured using the SquameScan 850. SquameScan 850 is an instrument used to measure the protein content extracted from the skin by D-Squame tape strips. The determination is carried out by measuring the optical absorption of the strip at 850 nm. Value displayed in percentage (%) was proportionally related to protein content. An 24 D-Squame discs were taken from participant (two sets of 12 discs from the two separate sites of each lower leg). The protein content was analyzed for each of the discs obtained from the D-Squame stripping on area 7 (right leg) and area 8 (left leg) on Day 29.
Change From Baseline in TEWL Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 30, 31, 32, 33 and 34	Baseline, Day 30, 31, 32, 33 and 34	TEWL was measured using the Tewameter TM 300. TEWL is a non-invasive method to measure the integrity of stratum corneum barrier function. Tewameter probe measures the density gradient of the water evaporation from the skin indirectly by two pairs of sensors (temperature and relative humidity) inside a hollow cylinder. The probe was held in place on the skin for one measurement, for 40 sec, to ensure that a stable value has been established. The values of the last 10 sec are averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function. TEWL was measured at area 5 (right leg) and 6 (left leg) at baseline visit (Visit 2) prior to any study product application and then measured throughout the study period per the study schedule. Change from baseline was calculated as the value at specified visit (Visit 5/Day 29) minus the baseline value.

Countries

Germany

Participant flow

Recruitment details

All participants were enrolled at one center in Germany.

Pre-assignment details

A total 174 participants were screened, out of which 158 participants were enrolled, 149 participants were randomized and 25 participants not randomized. Out of 149 randomized participants, 7 participants did not completed study because 3 participants experienced adverse event, 3 participants withdrew consent and 1 participant due to other reason.

Participants by arm

Arm	Count
Treatment Regimen 1 (Test Product 1 + Standard Soap) Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants applied allocated test product 1 topically, (approximately 0.3 mL × 2 pumps = 0.6 mL, each pump contains 0.3 mL) on face and (approximately 0.3 mL × 6 pumps = 1.8 mL, each pump contains 0.3 mL) on leg after cleansing with standard cleanser (simple pure soap), to the designated side per randomization, the same side of the face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.	75
Treatment Regimen 2 (Test Product 2 + Standard Soap) Participants randomized to this treatment regimen and were further randomized within regimen left and right side in equal proportion. Participants randomized to this treatment regimen and were further randomized within regimen left and right side. Participants applied allocated test product 2 topically, (approximately 0.3 mL × 2 pumps = 0.6 mL, each pump contains 0.3 mL) on face and (approximately 0.3 mL × 6 pumps = 1.8 mL, each pump contains 0.3 mL) on leg after cleansing with standard cleanser (simple pure soap), to the designated side per randomization, the same side of the face including forehead and chin and the same leg (left or right), twice a day (morning and evening) for 4 weeks. Morning and evening applications were separated by approximately 8 to 12 hrs.	74
Total	149

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	0	3
Overall Study	Other	0	1
Overall Study	Withdrawal by Subject	2	1

Baseline characteristics

Characteristic	Treatment Regimen 1 (Test Product 1 + Standard Soap)	Total	Treatment Regimen 2 (Test Product 2 + Standard Soap)
Age, Continuous	52.8 Years STANDARD_DEVIATION 9.64	51.2 Years STANDARD_DEVIATION 10.95	49.6 Years STANDARD_DEVIATION 11.98
Fitzpatrick Skin Type Grading III - Light brown skin	33 Participants	68 Participants	35 Participants
Fitzpatrick Skin Type Grading II - White skin	35 Participants	67 Participants	32 Participants
Fitzpatrick Skin Type Grading I - Pale white skin	5 Participants	9 Participants	4 Participants
Fitzpatrick Skin Type Grading IV - Moderate brown skin	2 Participants	5 Participants	3 Participants
Fitzpatrick Skin Type Grading V - Dark brown skin	0 Participants	0 Participants	0 Participants
Fitzpatrick Skin Type Grading VI - Deeply pigmented dark brown to black skin	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized African American/African Heritage	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	1 Participants	1 Participants	0 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized White - Arabic/North African Heritage	1 Participants	2 Participants	1 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	73 Participants	146 Participants	73 Participants
Sex: Female, Male Female	75 Participants	149 Participants	74 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk
deaths Total, all-cause mortality	0 / 75	0 / 74	0 / 75	0 / 74	0 / 149
other Total, other adverse events	19 / 75	23 / 74	5 / 75	4 / 74	7 / 149
serious Total, serious adverse events	0 / 75	0 / 74	0 / 75	0 / 74	0 / 149

Outcome results

Primary

Change From Baseline in Trans-epidermal Water Loss (TEWL) Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 29

TEWL was measured using the Tewameter TM 300. TEWL is a non-invasive method to measure the integrity of stratum corneum barrier function. Tewameter probe measures the density gradient of the water evaporation from the skin indirectly by two pairs of sensors (temperature and relative humidity) inside a hollow cylinder. The probe was held in place on the skin for one measurement, for 40 sec, to ensure that a stable value has been established. The values of the last 10 sec are averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function. TEWL was measured at area 1 (right face) and 2 (left face) at baseline visit (Visit 2) prior to any study product application and then measured throughout the study period per the study schedule. Change from baseline was calculated as the value at specified visit (Visit 5/Day 29) minus the baseline value.

Time frame: Baseline and Day 29

Population: Modified Intent-to-Treat (MITT) population. Here, number analyzed indicates participants with available data for this outcome measure.

Arm	Measure	Value (MEAN)	Dispersion
Test Product 1	Change From Baseline in Trans-epidermal Water Loss (TEWL) Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 29	-5.077 g/m^2/hr	Standard Deviation 6.4082
Test Product 2	Change From Baseline in Trans-epidermal Water Loss (TEWL) Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 29	-4.946 g/m^2/hr	Standard Deviation 6.2628
Standard Cleanser Soap	Change From Baseline in Trans-epidermal Water Loss (TEWL) Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 29	-3.692 g/m^2/hr	Standard Deviation 6.0635

Secondary

Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 15 and 29

SC moisturization measured using the Corneometer CM 825. The measuring principle is based on changes in the capacitance of the measuring head, functioning as condensator. The electric field was created between gold conductors to enable the dielectricity of the SC to be measured. Because the dielectricity varies as a function of the skin's water content, the SC moisturization was measured. Corneometer probe was placed in contact with the skin of the participants test site for 1 to 2 sec per measurement. The measurement will be taken 5 times in total and then an average reading will be calculated for each site and time point. The Corneometer values lower than 30 i.u represent very dry skin and values between 30 to 50 i.u represent dry skin on the forearm. Higher value of Corneometer indicates high moisture content. The area 1 (right face) and area 2 (left face) were considered.

Time frame: Baseline, Day 15 and 29

Population: MITT Population. Here, number analyzed indicates participants with available data for this outcome measure. Baseline value is the value obtained on Day 1 (Visit 2) before study product application for Corneometer variable. Change from Baseline was calculated as the value at specified visit minus the Baseline value.

Arm	Measure	Group	Value (MEAN)	Dispersion
Test Product 1	Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 15 and 29	Day 15, Visit 4	11.448 i.u.	Standard Deviation 9.6078
Test Product 1	Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 15 and 29	Day 29, Visit 5	13.573 i.u.	Standard Deviation 9.6777
Test Product 2	Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 15 and 29	Day 15, Visit 4	11.517 i.u.	Standard Deviation 8.4413
Test Product 2	Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 15 and 29	Day 29, Visit 5	11.870 i.u.	Standard Deviation 7.8857
Standard Cleanser Soap	Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 15 and 29	Day 15, Visit 4	1.454 i.u.	Standard Deviation 8.5126
Standard Cleanser Soap	Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 15 and 29	Day 29, Visit 5	3.506 i.u.	Standard Deviation 8.4246

Secondary

Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 30, 31, 32, 33 and 34

Time frame: Baseline, Day 30, 31, 32, 33 and 34

Arm	Measure	Group	Value (MEAN)	Dispersion
Test Product 1	Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 30, 31, 32, 33 and 34	Day 33, Visit 9	2.839 i.u.	Standard Deviation 9.0299
Test Product 1	Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 30, 31, 32, 33 and 34	Day 32, Change at visit 8	3.948 i.u.	Standard Deviation 8.6287
Test Product 1	Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 30, 31, 32, 33 and 34	Day 30, Visit 6	7.279 i.u.	Standard Deviation 8.0036
Test Product 1	Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 30, 31, 32, 33 and 34	Day 31, Visit 7	5.581 i.u.	Standard Deviation 7.6171
Test Product 1	Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 30, 31, 32, 33 and 34	Day 34, Visit 10	1.965 i.u.	Standard Deviation 10.0299
Test Product 2	Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 30, 31, 32, 33 and 34	Day 32, Change at visit 8	1.823 i.u.	Standard Deviation 8.004
Test Product 2	Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 30, 31, 32, 33 and 34	Day 30, Visit 6	7.175 i.u.	Standard Deviation 8.4301
Test Product 2	Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 30, 31, 32, 33 and 34	Day 31, Visit 7	4.441 i.u.	Standard Deviation 8.3006
Test Product 2	Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 30, 31, 32, 33 and 34	Day 33, Visit 9	1.772 i.u.	Standard Deviation 7.9661
Test Product 2	Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 30, 31, 32, 33 and 34	Day 34, Visit 10	1.686 i.u.	Standard Deviation 7.5388
Standard Cleanser Soap	Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 30, 31, 32, 33 and 34	Day 34, Visit 10	0.682 i.u.	Standard Deviation 9.2882
Standard Cleanser Soap	Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 30, 31, 32, 33 and 34	Day 33, Visit 9	0.608 i.u.	Standard Deviation 9.6741
Standard Cleanser Soap	Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 30, 31, 32, 33 and 34	Day 30, Visit 6	2.927 i.u.	Standard Deviation 8.0479
Standard Cleanser Soap	Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 30, 31, 32, 33 and 34	Day 32, Change at visit 8	0.829 i.u.	Standard Deviation 8.7018
Standard Cleanser Soap	Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Day 30, 31, 32, 33 and 34	Day 31, Visit 7	1.866 i.u.	Standard Deviation 8.157

Secondary

Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Two Different Time-points [30 Minutes (Mins) and 6 Hrs After First Application] at Day 1 and One Time-point at Day 2

Stratum corneum (SC) moisturization measured using the Corneometer CM 825. The measuring principle is based on changes in the capacitance of the measuring head, functioning as condensator. The electric field was created between gold conductors to enable the dielectricity of the SC to be measured. Because the dielectricity varies as a function of the skin's water content, the SC moisturization was measured. Corneometer probe was placed in contact with the skin of the participants test site for 1 to 2 sec per measurement. The measurement will be taken 5 times in total and then an average reading will be calculated for each site and time point. The Corneometer values lower than 30 international units (i.u) represent very dry skin and values between 30 to 50 i.u represent dry skin on the forearm. Higher value of Corneometer indicates high moisture content. The area 1 (right face) and area 2 (left face) were considered.

Time frame: Baseline, 30 mins and 6 hrs after first treatment application on Day 1 and 24 hrs after treatment application on Day 2

Arm	Measure	Group	Value (MEAN)	Dispersion
Test Product 1	Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Two Different Time-points [30 Minutes (Mins) and 6 Hrs After First Application] at Day 1 and One Time-point at Day 2	Day 1, 6 hrs	14.756 International units (i.u.)	Standard Deviation 8.3951
Test Product 1	Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Two Different Time-points [30 Minutes (Mins) and 6 Hrs After First Application] at Day 1 and One Time-point at Day 2	Day 1, 30 mins, post-dose	24.628 International units (i.u.)	Standard Deviation 8.8144
Test Product 1	Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Two Different Time-points [30 Minutes (Mins) and 6 Hrs After First Application] at Day 1 and One Time-point at Day 2	Day 2, Visit 3	3.032 International units (i.u.)	Standard Deviation 7.5869
Test Product 2	Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Two Different Time-points [30 Minutes (Mins) and 6 Hrs After First Application] at Day 1 and One Time-point at Day 2	Day 1, 6 hrs	6.760 International units (i.u.)	Standard Deviation 7.3969
Test Product 2	Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Two Different Time-points [30 Minutes (Mins) and 6 Hrs After First Application] at Day 1 and One Time-point at Day 2	Day 1, 30 mins, post-dose	12.048 International units (i.u.)	Standard Deviation 9.3662
Test Product 2	Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Two Different Time-points [30 Minutes (Mins) and 6 Hrs After First Application] at Day 1 and One Time-point at Day 2	Day 2, Visit 3	1.707 International units (i.u.)	Standard Deviation 6.5054
Standard Cleanser Soap	Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Two Different Time-points [30 Minutes (Mins) and 6 Hrs After First Application] at Day 1 and One Time-point at Day 2	Day 1, 30 mins, post-dose	0.246 International units (i.u.)	Standard Deviation 5.4461
Standard Cleanser Soap	Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Two Different Time-points [30 Minutes (Mins) and 6 Hrs After First Application] at Day 1 and One Time-point at Day 2	Day 2, Visit 3	-1.765 International units (i.u.)	Standard Deviation 7.7254
Standard Cleanser Soap	Change From Baseline in Corneometer Values Following Application of Test Regimen on Face (Area 1 Compared to Area 2) at Two Different Time-points [30 Minutes (Mins) and 6 Hrs After First Application] at Day 1 and One Time-point at Day 2	Day 1, 6 hrs	-0.381 International units (i.u.)	Standard Deviation 6.8182

Secondary

Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 15 and 29

SC moisturization measured using the Corneometer CM 825. The measuring principle is based on changes in the capacitance of the measuring head, functioning as condensator. The electric field was created between gold conductors to enable the dielectricity of the SC to be measured. Because the dielectricity varies as a function of the skin's water content, the SC moisturization was measured. Corneometer probe was placed in contact with the skin of the participants test site for 1 to 2 sec per measurement. The measurement will be taken 5 times in total and then an average reading will be calculated for each site and time point. The Corneometer values lower than 30 i.u represent very dry skin and values between 30 to 50 i.u represent dry skin on the forearm. Higher value of Corneometer indicates high moisture content. The area 5 (right leg) and area 6 (left leg) were considered.

Time frame: Baseline, Day 15 and Day 29

Arm	Measure	Group	Value (MEAN)	Dispersion
Test Product 1	Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 15 and 29	Day 15, Visit 4	8.538 i.u.	Standard Deviation 6.3133
Test Product 1	Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 15 and 29	Day 29, Visit 5	8.443 i.u.	Standard Deviation 7.6121
Test Product 2	Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 15 and 29	Day 15, Visit 4	7.452 i.u.	Standard Deviation 6.755
Test Product 2	Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 15 and 29	Day 29, Visit 5	8.944 i.u.	Standard Deviation 8.5479
Standard Cleanser Soap	Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 15 and 29	Day 15, Visit 4	-1.094 i.u.	Standard Deviation 5.9129
Standard Cleanser Soap	Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 15 and 29	Day 29, Visit 5	-1.273 i.u.	Standard Deviation 6.7258

Secondary

Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 30, 31, 32, 33 and 34

SC moisturization measured using the Corneometer CM 825. The measuring principle is based on changes in the capacitance of the measuring head, functioning as condensator. The electric field was created between gold conductors to enable the dielectricity of the SC to be measured. Because the dielectricity varies as a function of the skin's water content, the SC moisturization was measured. Corneometer probe was placed in contact with the skin of the participants test site for 1 to 2 sec per measurement. The measurement will be taken 5 times in total and then an average reading will be calculated for each site and time point. The Corneometer values lower than 30 i.u represent very dry skin and values between 30 to 50 i.u represent dry skin on the forearm. Higher value of Corneometer indicates high moisture content. The area 5 (right leg) and area 6 (left leg) were considered.

Time frame: Baseline, Day 30, 31, 32, 33 and 34

Arm	Measure	Group	Value (MEAN)	Dispersion
Test Product 1	Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 30, 31, 32, 33 and 34	Day 33, Visit 9	2.135 i.u.	Standard Deviation 6.1634
Test Product 1	Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 30, 31, 32, 33 and 34	Day 32, Visit 8	2.549 i.u.	Standard Deviation 6.8103
Test Product 1	Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 30, 31, 32, 33 and 34	Day 30, Visit 6	4.738 i.u.	Standard Deviation 6.9914
Test Product 1	Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 30, 31, 32, 33 and 34	Day 31, Visit 7	2.943 i.u.	Standard Deviation 6.6218
Test Product 1	Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 30, 31, 32, 33 and 34	Day 34, Visit 10	3.894 i.u.	Standard Deviation 6.396
Test Product 2	Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 30, 31, 32, 33 and 34	Day 32, Visit 8	4.054 i.u.	Standard Deviation 6.8908
Test Product 2	Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 30, 31, 32, 33 and 34	Day 30, Visit 6	5.372 i.u.	Standard Deviation 7.1154
Test Product 2	Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 30, 31, 32, 33 and 34	Day 31, Visit 7	5.843 i.u.	Standard Deviation 7.3787
Test Product 2	Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 30, 31, 32, 33 and 34	Day 33, Visit 9	3.939 i.u.	Standard Deviation 7.9278
Test Product 2	Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 30, 31, 32, 33 and 34	Day 34, Visit 10	5.627 i.u.	Standard Deviation 7.2834
Standard Cleanser Soap	Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 30, 31, 32, 33 and 34	Day 34, Visit 10	-0.942 i.u.	Standard Deviation 6.8374
Standard Cleanser Soap	Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 30, 31, 32, 33 and 34	Day 33, Visit 9	-2.732 i.u.	Standard Deviation 6.015
Standard Cleanser Soap	Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 30, 31, 32, 33 and 34	Day 30, Visit 6	-2.692 i.u.	Standard Deviation 6.6993
Standard Cleanser Soap	Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 30, 31, 32, 33 and 34	Day 32, Visit 8	-2.673 i.u.	Standard Deviation 6.409
Standard Cleanser Soap	Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Day 30, 31, 32, 33 and 34	Day 31, Visit 7	-2.223 i.u.	Standard Deviation 6.987

Secondary

Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Two Different Time-points (30 Mins and 6 Hrs After First Application) at Day 1 and One Time-point at Day 2

SC moisturization measured using the Corneometer CM 825. The measuring principle is based on changes in the capacitance of the measuring head, functioning as condensator. The electric field was created between gold conductors to enable the dielectricity of the SC to be measured. Because the dielectricity varies as a function of the skin's water content, the SC moisturization was measured. Corneometer probe was placed in contact with the skin of the participants test site for 1 to 2 sec per measurement. The measurement will be taken 5 times in total and then an average reading will be calculated for each site and time point. The Corneometer values lower than 30 i.u represent very dry skin and values between 30 to 50 i.u represent dry skin on the forearm. Higher value of Corneometer indicates high moisture content. The area 5 (right leg) and area 6 (left leg) were considered.

Time frame: Baseline, Day 1 and Day 2

Arm	Measure	Group	Value (MEAN)	Dispersion
Test Product 1	Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Two Different Time-points (30 Mins and 6 Hrs After First Application) at Day 1 and One Time-point at Day 2	Day 1, 6 hrs	0.762 i.u.	Standard Deviation 5.2888
Test Product 1	Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Two Different Time-points (30 Mins and 6 Hrs After First Application) at Day 1 and One Time-point at Day 2	Day 1, 30 mins, post-dose	9.636 i.u.	Standard Deviation 5.6719
Test Product 1	Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Two Different Time-points (30 Mins and 6 Hrs After First Application) at Day 1 and One Time-point at Day 2	Day 2, Visit 3	2.116 i.u.	Standard Deviation 5.1318
Test Product 2	Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Two Different Time-points (30 Mins and 6 Hrs After First Application) at Day 1 and One Time-point at Day 2	Day 1, 6 hrs	0.096 i.u.	Standard Deviation 5.0023
Test Product 2	Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Two Different Time-points (30 Mins and 6 Hrs After First Application) at Day 1 and One Time-point at Day 2	Day 1, 30 mins, post-dose	7.537 i.u.	Standard Deviation 5.171
Test Product 2	Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Two Different Time-points (30 Mins and 6 Hrs After First Application) at Day 1 and One Time-point at Day 2	Day 2, Visit 3	0.685 i.u.	Standard Deviation 5.2522
Standard Cleanser Soap	Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Two Different Time-points (30 Mins and 6 Hrs After First Application) at Day 1 and One Time-point at Day 2	Day 1, 30 mins, post-dose	-0.934 i.u.	Standard Deviation 2.563
Standard Cleanser Soap	Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Two Different Time-points (30 Mins and 6 Hrs After First Application) at Day 1 and One Time-point at Day 2	Day 2, Visit 3	-2.341 i.u.	Standard Deviation 4.8045
Standard Cleanser Soap	Change From Baseline in Corneometer Values Following Application of Test Regimen on Legs (Area 5 Compared to Area 6) at Two Different Time-points (30 Mins and 6 Hrs After First Application) at Day 1 and One Time-point at Day 2	Day 1, 6 hrs	-7.120 i.u.	Standard Deviation 3.6854

Secondary