Acne Vulgaris
Conditions
Keywords
Acne
Brief summary
This is a single-blind (blinded expert grader), randomized, half-face study being conducted at one clinical site. On 1 side of the face, the subject will apply 1 of the 2 test products, antibiotic and benzoyl peroxide or benzoyl peroxide and adapalene gel and the contra lateral side of the face will remain non-treated to serve as a control. Approximately 25-30 male and female healthy subjects will be randomly assigned to each product
Detailed description
This is a single-blind (blinded expert grader), parallel group, randomized, half-face study being conducted at one clinical site. On 1 side of the face, the subject will apply 1 of the 2 test products, a topical antibiotic and benzoyl peroxide or benzoyl peroxide and adapalene and the contra lateral side of the face will remain non-treated to serve as a control. Approximately 25-30 male and female healthy subjects will be randomly assigned to each product. The subjects will be entered into a 2-week treatment phase. The once-daily applications for the study medication will be supervised at the site, Monday through Friday of each week. Subjects will apply the study product at home on Saturdays and Sundays. A blinded expert grader will rate comparative product tolerance on each week day (excluding Saturdays and Sundays) during the study before study product is applied. Subject questionnaires will be completed along with collection of all adverse events.
Interventions
Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide gel. This contains a topical antibiotic and benzoyl peroxide gel.
DRUGbenzoyl peroxide 2.5% and adapalene 0.1% gel
Once-daily applications, to the randomized side of the face either left or right,benzoyl peroxide and adapalene gel
Sponsors
GlaxoSmithKline
Stiefel, a GSK Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Subjects 18 to 45 years of age or older, able to complete the study and comply with study instructions. * Female subjects of childbearing potential must have a negative pregnancy test. Sexually active women of childbearing potential participating in the study must have been using a medically acceptable form of contraception * Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol specific procedures are performed. * Is willing to discontinue use of all facial products (other than the cleanser provided and makeup or razor and facial shave product) on the face for the 3 days before their baseline/day 0 visit and use only the provided facial products and their normal makeup or razor and facial shaving product for the duration of the study. * Is willing to avoid sunburn, tanning, tanning beds or other excessive sun exposure. Understands that if their skin tone changes significantly during the study it will be necessary to discontinue their participation.
Exclusion criteria
* Male subjects that have facial beards (mustache and/or goatee is acceptable). * Is a Type I diabetic. * Has active or chronic skin allergies. * Has a history of acute or chronic disease that might interfere with, or increase the risk of study participation. * Has participated in other facial studies in the preceding 30 days or other clinical studies in preceding 14 days. * Had skin cancer treatment in preceding 12 months. * Has damaged skin on facial areas (eg, from sunburn, tattoos, scars). * Had any medical procedure (eg, laser resurfacing, chemical peels, plastic surgery) to facial areas in preceding 12 months. * Had any cosmetic procedure (eg, microdermabrasion, etc.) to facial areas within 8 weeks of the baseline visit. * Live in the same household as currently enrolled subjects. * Any other condition or factor the investigator or his duly assigned representative believes may affect the skin response or the interpretation of the test results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin Erythema (Redness) | Baseline, Day 1 through Day 14 | Assessment of erythema as part of an evaluation of tolerance of two treatments: clindamycin and benzoyl peroxide or dapsone gel. This was done by visual assessment by an independent blinded grader using the grading scale shown below. Grade Description 0 None 2 Mild erythema 4 Moderate confluent erythema 6 Marked erythema with some edema 8 Marked erythema, edema, possible erosion |
| Skin Dryness | Baseline, Day 1 through Day 14 | The amount of dryness on the left and right cheek of each panelist. The scale used to evaluate skin dryness is: Grade Description 0 None 2 Slight flaking 4 Moderate flaking/scaling 6 Marked scaling / slight fissuring 8 Severe scaling, fissuring Expert Grader assessments of dryness were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self Assessment of Burning | Baseline, Day 1 through Day 14 | The amount of burning on the left and right cheek of each panelist. The scale used to evaluate burning is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14. |
| Self Assessment of Stinging | Baseline, Day 1 through Day 14 | The amount of stinging on the left and right cheek of each panelist. The scale used to evaluate stinging is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of stinging were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14. |
| Self Assessment of Dryness | Baseline, Day 1 through Day 14 | The amount of dryness on the left and right cheek of each panelist. The scale used to evaluate dryness is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14. |
| Self Assessment of Texture (Roughness) | Baseline, Day 1 through Day 14 | The amount of roughness on the left and right cheek of each panelist. The scale used to evaluate roughness is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14. |
| Self Assessment of Pain | Baseline, Day 1 through Day 14 | The amount of pain on the left and right cheek of each panelist. The scale used to evaluate pain is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14. |
| Self Assessment of Crusting | Baseline, Day 1 through Day 14 | The amount of crusting on the left and right cheek of each panelist. The scale used to evaluate crusting is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14. |
| Self Assessment of Blistering | Baseline, Day 1 through Day 14 | The amount of blistering on the left and right cheek of each panelist. The scale used to evaluate blistering is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14. |
| Skin Moisture and Hydration | Baseline, Days 3, 7, and 14 | To assess skin moisture and hydration using transepidermal water loss (TEWL). Results are measured on a continuous scale. Higher values indicate greater water loss/ lower skin moisture levels. Evaporative water loss measurements provide an instrumental assessment of skin barrier function(one of the layers of the skin. Damage leads to a disruption of the barrier that is accompanied by elevated water loss rates and affects skin moisture and hydration. Higher values indicate greater water loss. |
| Product Acceptability and Preference Questionnaire - How do You Rate the Comfort of the Skin Where You Are Currently Treating With the Study Product? | Day 14 | The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: How do you rate the comfort of the skin where you are currently treating with the study product? The subject replied using the following scale: 1. \- Very Comfortable 2. \- Comfortable 3. \- Somewhat Comfortable 4. \- Somewhat Uncomfortable 5. \- Uncomfortable |
| Product Acceptability and Preference Questionnaire - How Compliant Were You With Applying the Study Product Each and Every Day? | Day 14 | The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: How compliant were you with applying the study product each and every day? The subject replied using the following scale: 0 - Not Compliant at all (\<50%) 1. \- Mostly Compliant (50%-79%) 2. \- Very Compliant (80%-100%) |
| Product Acceptability and Preference Questionnaire - Did You Feel That Your Skin Was Hydrated and Moisturized While You Were on Your Study Product? | Day 14 | The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product? The subject replied using the following scale: 1 - Yes 0 - No |
| Product Acceptability and Preference Questionnaire - Was the Study Product Easy to Use With Make-up? | Day 14 | The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Was the study product easy to use with make-up? The subject replied using the following scale: 0 - Not Applicable 1. \- Very Easy 2. \- Easy 3. \- Neutral 4. \- Difficult 5. \- Very Difficult |
| Product Acceptability and Preference Questionnaire - What Was Your Overall Satisfaction of the Study Product? | Day 14 | The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: What was your overall satisfaction of the study product? The subject replied using the following scale: 1. \- Very Satisfied 2. \- Satisfied 3. \- Neutral 4. \- Unsatisfied 5. \- Very Unsatisfied |
| Product Acceptability and Preference Questionnaire - How do You Rate the Ease of Application of the Study Product? | Day 14 | The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Was the study product easy to use with make-up? The subject replied using the following scale: 0 - Not Applicable 1. \- Very Easy 2. \- Easy 3. \- Neutral 4. \- Difficult 5. \- Very Difficult |
| Self Assessment of Oiliness | Baseline, Day 1 through Day 14 | The amount of oiliness on the left and right cheek of each panelist. The scale used to evaluate oiliness is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14. |
| Skin Hydration | Baseline, 4 hrs. post 1st Treatment, Days 3, 7, and 14 | The ability of an alternating current to flow through the stratum corneum is an indirect measure of its water content. The value recorded is expressed in microsiemens. Higher values indicate greater levels of skin hydration. Test results were compared to measurements from the other side of the face, which was not treated instead of referring to a normal range. A normal range does not exist for this measurement. Instead, the non-treated side of the face was used as a control to determine the normal level of skin hydration. |
Countries
United States
Participant flow
Recruitment details
Clinical research center.
Pre-assignment details
Panelists who met the eligibility criteria and were willing to participate in the study were required to undergo a 3-day pre-trial conditioning period where they had to stop the use of all facial products. Panelists were required to use the provided Soap Free Cleanser (SFC) for washing their face and were allowed to apply their normal makeup.
Participants by arm
| Arm | Count |
|---|---|
| Duac Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide | 25 |
| Epiduo Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene | 27 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Skin Irritation | 1 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Duac | Epiduo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 26 Participants | 50 Participants |
| Region of Enrollment United States | 25 participants | 27 participants | 52 participants |
| Sex: Female, Male Female | 23 Participants | 26 Participants | 49 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / 25 | 13 / 27 |
| serious Total, serious adverse events | 0 / 25 | 0 / 27 |
Outcome results
Primary
Skin Dryness
The amount of dryness on the left and right cheek of each panelist. The scale used to evaluate skin dryness is: Grade Description 0 None 2 Slight flaking 4 Moderate flaking/scaling 6 Marked scaling / slight fissuring 8 Severe scaling, fissuring Expert Grader assessments of dryness were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.
Time frame: Baseline, Day 1 through Day 14
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac | Skin Dryness | Day 3 | 0.46 units on a scale | Standard Deviation 0.91 |
| Duac | Skin Dryness | Day 8 | 0.60 units on a scale | Standard Deviation 1.13 |
| Duac | Skin Dryness | Day 2 | 0.32 units on a scale | Standard Deviation 0.83 |
| Duac | Skin Dryness | Day 9 | 0.73 units on a scale | Standard Deviation 1.28 |
| Duac | Skin Dryness | Day 6 | 0.61 units on a scale | Standard Deviation 1.02 |
| Duac | Skin Dryness | Day 10 | 0.56 units on a scale | Standard Deviation 1.04 |
| Duac | Skin Dryness | Day 1 | 0.41 units on a scale | Standard Deviation 0.85 |
| Duac | Skin Dryness | Day 13 | 0.80 units on a scale | Standard Deviation 1.33 |
| Duac | Skin Dryness | Day 7 | 0.69 units on a scale | Standard Deviation 1.16 |
| Duac | Skin Dryness | Day 14 | 0.79 units on a scale | Standard Deviation 1.04 |
| Duac | Skin Dryness | Baseline | 0.12 units on a scale | Standard Deviation 0.44 |
| Epiduo | Skin Dryness | Day 14 | 1.33 units on a scale | Standard Deviation 1.75 |
| Epiduo | Skin Dryness | Baseline | 0.07 units on a scale | Standard Deviation 0.27 |
| Epiduo | Skin Dryness | Day 1 | 0.25 units on a scale | Standard Deviation 0.57 |
| Epiduo | Skin Dryness | Day 2 | 0.34 units on a scale | Standard Deviation 0.59 |
| Epiduo | Skin Dryness | Day 3 | 0.55 units on a scale | Standard Deviation 1.15 |
| Epiduo | Skin Dryness | Day 6 | 1.73 units on a scale | Standard Deviation 1.76 |
| Epiduo | Skin Dryness | Day 7 | 1.85 units on a scale | Standard Deviation 2.01 |
| Epiduo | Skin Dryness | Day 8 | 1.87 units on a scale | Standard Deviation 2.04 |
| Epiduo | Skin Dryness | Day 9 | 2.29 units on a scale | Standard Deviation 1.99 |
| Epiduo | Skin Dryness | Day 10 | 1.49 units on a scale | Standard Deviation 1.77 |
| Epiduo | Skin Dryness | Day 13 | 1.26 units on a scale | Standard Deviation 1.85 |
p-value: >0.05Dunn's Multiple Comparisons Test
Primary
Skin Erythema (Redness)
Assessment of erythema as part of an evaluation of tolerance of two treatments: clindamycin and benzoyl peroxide or dapsone gel. This was done by visual assessment by an independent blinded grader using the grading scale shown below. Grade Description 0 None 2 Mild erythema 4 Moderate confluent erythema 6 Marked erythema with some edema 8 Marked erythema, edema, possible erosion
Time frame: Baseline, Day 1 through Day 14
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac | Skin Erythema (Redness) | Day 3 | 3.08 Units on a scale | Standard Deviation 1.23 |
| Duac | Skin Erythema (Redness) | Day 8 | 2.87 Units on a scale | Standard Deviation 1.24 |
| Duac | Skin Erythema (Redness) | Day 2 | 2.90 Units on a scale | Standard Deviation 1.23 |
| Duac | Skin Erythema (Redness) | Day 9 | 2.78 Units on a scale | Standard Deviation 1.36 |
| Duac | Skin Erythema (Redness) | Day 6 | 3.17 Units on a scale | Standard Deviation 1.33 |
| Duac | Skin Erythema (Redness) | Day 10 | 2.89 Units on a scale | Standard Deviation 1.22 |
| Duac | Skin Erythema (Redness) | Day 1 | 2.62 Units on a scale | Standard Deviation 1.32 |
| Duac | Skin Erythema (Redness) | Day 13 | 2.85 Units on a scale | Standard Deviation 1.2 |
| Duac | Skin Erythema (Redness) | Day 7 | 3.07 Units on a scale | Standard Deviation 1.3 |
| Duac | Skin Erythema (Redness) | Day 14 | 2.73 Units on a scale | Standard Deviation 1.2 |
| Duac | Skin Erythema (Redness) | Baseline | 1.56 Units on a scale | Standard Deviation 0.92 |
| Epiduo | Skin Erythema (Redness) | Day 14 | 2.56 Units on a scale | Standard Deviation 1.03 |
| Epiduo | Skin Erythema (Redness) | Baseline | 1.89 Units on a scale | Standard Deviation 1.01 |
| Epiduo | Skin Erythema (Redness) | Day 1 | 2.65 Units on a scale | Standard Deviation 0.94 |
| Epiduo | Skin Erythema (Redness) | Day 2 | 2.52 Units on a scale | Standard Deviation 1.03 |
| Epiduo | Skin Erythema (Redness) | Day 3 | 2.81 Units on a scale | Standard Deviation 1.02 |
| Epiduo | Skin Erythema (Redness) | Day 6 | 3.13 Units on a scale | Standard Deviation 0.89 |
| Epiduo | Skin Erythema (Redness) | Day 7 | 3.08 Units on a scale | Standard Deviation 1.01 |
| Epiduo | Skin Erythema (Redness) | Day 8 | 2.98 Units on a scale | Standard Deviation 1.08 |
| Epiduo | Skin Erythema (Redness) | Day 9 | 3.03 Units on a scale | Standard Deviation 0.99 |
| Epiduo | Skin Erythema (Redness) | Day 10 | 2.94 Units on a scale | Standard Deviation 1.02 |
| Epiduo | Skin Erythema (Redness) | Day 13 | 2.83 Units on a scale | Standard Deviation 1.21 |
p-value: >0.05Dunn's Multiple Comparisons Test
Secondary
Product Acceptability and Preference Questionnaire - Did You Feel That Your Skin Was Hydrated and Moisturized While You Were on Your Study Product?
The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product? The subject replied using the following scale: 1 - Yes 0 - No
Time frame: Day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duac | Product Acceptability and Preference Questionnaire - Did You Feel That Your Skin Was Hydrated and Moisturized While You Were on Your Study Product? | 0.58 units on a scale | Standard Deviation 0.5 |
| Epiduo | Product Acceptability and Preference Questionnaire - Did You Feel That Your Skin Was Hydrated and Moisturized While You Were on Your Study Product? | 0.54 units on a scale | Standard Deviation 0.51 |
Secondary
Product Acceptability and Preference Questionnaire - How Compliant Were You With Applying the Study Product Each and Every Day?
The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: How compliant were you with applying the study product each and every day? The subject replied using the following scale: 0 - Not Compliant at all (\<50%) 1. \- Mostly Compliant (50%-79%) 2. \- Very Compliant (80%-100%)
Time frame: Day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duac | Product Acceptability and Preference Questionnaire - How Compliant Were You With Applying the Study Product Each and Every Day? | 2.00 units on a scale | Standard Deviation 0 |
| Epiduo | Product Acceptability and Preference Questionnaire - How Compliant Were You With Applying the Study Product Each and Every Day? | 2.00 units on a scale | Standard Deviation 0 |
Secondary
Product Acceptability and Preference Questionnaire - How do You Rate the Comfort of the Skin Where You Are Currently Treating With the Study Product?
The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: How do you rate the comfort of the skin where you are currently treating with the study product? The subject replied using the following scale: 1. \- Very Comfortable 2. \- Comfortable 3. \- Somewhat Comfortable 4. \- Somewhat Uncomfortable 5. \- Uncomfortable
Time frame: Day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duac | Product Acceptability and Preference Questionnaire - How do You Rate the Comfort of the Skin Where You Are Currently Treating With the Study Product? | 2.38 units on a scale | Standard Deviation 1.13 |
| Epiduo | Product Acceptability and Preference Questionnaire - How do You Rate the Comfort of the Skin Where You Are Currently Treating With the Study Product? | 2.23 units on a scale | Standard Deviation 1.24 |
Secondary
Product Acceptability and Preference Questionnaire - How do You Rate the Ease of Application of the Study Product?
The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Was the study product easy to use with make-up? The subject replied using the following scale: 0 - Not Applicable 1. \- Very Easy 2. \- Easy 3. \- Neutral 4. \- Difficult 5. \- Very Difficult
Time frame: Day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duac | Product Acceptability and Preference Questionnaire - How do You Rate the Ease of Application of the Study Product? | 1.17 units on a scale | Standard Deviation 0.38 |
| Epiduo | Product Acceptability and Preference Questionnaire - How do You Rate the Ease of Application of the Study Product? | 1.00 units on a scale | Standard Deviation 0 |
Secondary
Product Acceptability and Preference Questionnaire - Was the Study Product Easy to Use With Make-up?
The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Was the study product easy to use with make-up? The subject replied using the following scale: 0 - Not Applicable 1. \- Very Easy 2. \- Easy 3. \- Neutral 4. \- Difficult 5. \- Very Difficult
Time frame: Day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duac | Product Acceptability and Preference Questionnaire - Was the Study Product Easy to Use With Make-up? | 1.04 units on a scale | Standard Deviation 1.12 |
| Epiduo | Product Acceptability and Preference Questionnaire - Was the Study Product Easy to Use With Make-up? | 1.46 units on a scale | Standard Deviation 1.14 |
Secondary
Product Acceptability and Preference Questionnaire - What Was Your Overall Satisfaction of the Study Product?
The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: What was your overall satisfaction of the study product? The subject replied using the following scale: 1. \- Very Satisfied 2. \- Satisfied 3. \- Neutral 4. \- Unsatisfied 5. \- Very Unsatisfied
Time frame: Day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duac | Product Acceptability and Preference Questionnaire - What Was Your Overall Satisfaction of the Study Product? | 2.29 units on a scale | Standard Deviation 1.04 |
| Epiduo | Product Acceptability and Preference Questionnaire - What Was Your Overall Satisfaction of the Study Product? | 2.46 units on a scale | Standard Deviation 1.03 |
Secondary
Self Assessment of Blistering
The amount of blistering on the left and right cheek of each panelist. The scale used to evaluate blistering is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.
Time frame: Baseline, Day 1 through Day 14
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac | Self Assessment of Blistering | Day 2 | 0.00 units on a scale | Standard Deviation 0 |
| Duac | Self Assessment of Blistering | Day 8 | 0.00 units on a scale | Standard Deviation 0 |
| Duac | Self Assessment of Blistering | Day 1 | 0.00 units on a scale | Standard Deviation 0 |
| Duac | Self Assessment of Blistering | Day 9 | 0.00 units on a scale | Standard Deviation 0 |
| Duac | Self Assessment of Blistering | Day 3 | 0.00 units on a scale | Standard Deviation 0 |
| Duac | Self Assessment of Blistering | Day 10 | 0.00 units on a scale | Standard Deviation 0 |
| Duac | Self Assessment of Blistering | Day 6 | 0.00 units on a scale | Standard Deviation 0 |
| Duac | Self Assessment of Blistering | Day 13 | 0.00 units on a scale | Standard Deviation 0 |
| Duac | Self Assessment of Blistering | Baseline | 0.00 units on a scale | Standard Deviation 0 |
| Duac | Self Assessment of Blistering | Day 14 | 0.00 units on a scale | Standard Deviation 0 |
| Duac | Self Assessment of Blistering | Day 7 | 0.00 units on a scale | Standard Deviation 0 |
| Epiduo | Self Assessment of Blistering | Day 14 | 0.00 units on a scale | Standard Deviation 0 |
| Epiduo | Self Assessment of Blistering | Baseline | 0.00 units on a scale | Standard Deviation 0 |
| Epiduo | Self Assessment of Blistering | Day 1 | 0.00 units on a scale | Standard Deviation 0 |
| Epiduo | Self Assessment of Blistering | Day 2 | 0.00 units on a scale | Standard Deviation 0 |
| Epiduo | Self Assessment of Blistering | Day 6 | 0.07 units on a scale | Standard Deviation 0.38 |
| Epiduo | Self Assessment of Blistering | Day 7 | 0.04 units on a scale | Standard Deviation 0.19 |
| Epiduo | Self Assessment of Blistering | Day 8 | 0.00 units on a scale | Standard Deviation 0 |
| Epiduo | Self Assessment of Blistering | Day 9 | 0.00 units on a scale | Standard Deviation 0 |
| Epiduo | Self Assessment of Blistering | Day 10 | 0.00 units on a scale | Standard Deviation 0 |
| Epiduo | Self Assessment of Blistering | Day 13 | 0.00 units on a scale | Standard Deviation 0 |
| Epiduo | Self Assessment of Blistering | Day 3 | 0.00 units on a scale | Standard Deviation 0 |
Secondary
Self Assessment of Burning
The amount of burning on the left and right cheek of each panelist. The scale used to evaluate burning is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.
Time frame: Baseline, Day 1 through Day 14
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac | Self Assessment of Burning | Day 3 | 0.12 units on a scale | Standard Deviation 0.33 |
| Duac | Self Assessment of Burning | Day 8 | 0.17 units on a scale | Standard Deviation 0.48 |
| Duac | Self Assessment of Burning | Day 2 | 0.04 units on a scale | Standard Deviation 0.2 |
| Duac | Self Assessment of Burning | Day 9 | 0.13 units on a scale | Standard Deviation 0.45 |
| Duac | Self Assessment of Burning | Day 6 | 0.12 units on a scale | Standard Deviation 0.33 |
| Duac | Self Assessment of Burning | Day 10 | 0.13 units on a scale | Standard Deviation 0.45 |
| Duac | Self Assessment of Burning | Day 1 | 0.04 units on a scale | Standard Deviation 0.2 |
| Duac | Self Assessment of Burning | Day 13 | 0.08 units on a scale | Standard Deviation 0.28 |
| Duac | Self Assessment of Burning | Day 7 | 0.17 units on a scale | Standard Deviation 0.48 |
| Duac | Self Assessment of Burning | Day 14 | 0.08 units on a scale | Standard Deviation 0.28 |
| Duac | Self Assessment of Burning | Baseline | 0.00 units on a scale | Standard Deviation 0 |
| Epiduo | Self Assessment of Burning | Day 14 | 0.19 units on a scale | Standard Deviation 0.57 |
| Epiduo | Self Assessment of Burning | Baseline | 0.00 units on a scale | Standard Deviation 0 |
| Epiduo | Self Assessment of Burning | Day 1 | 0.04 units on a scale | Standard Deviation 0.19 |
| Epiduo | Self Assessment of Burning | Day 2 | 0.04 units on a scale | Standard Deviation 0.19 |
| Epiduo | Self Assessment of Burning | Day 3 | 0.15 units on a scale | Standard Deviation 0.36 |
| Epiduo | Self Assessment of Burning | Day 6 | 0.56 units on a scale | Standard Deviation 0.85 |
| Epiduo | Self Assessment of Burning | Day 7 | 0.70 units on a scale | Standard Deviation 0.87 |
| Epiduo | Self Assessment of Burning | Day 8 | 0.50 units on a scale | Standard Deviation 0.81 |
| Epiduo | Self Assessment of Burning | Day 9 | 0.27 units on a scale | Standard Deviation 0.67 |
| Epiduo | Self Assessment of Burning | Day 10 | 0.31 units on a scale | Standard Deviation 0.68 |
| Epiduo | Self Assessment of Burning | Day 13 | 0.35 units on a scale | Standard Deviation 0.75 |
Secondary
Self Assessment of Crusting
The amount of crusting on the left and right cheek of each panelist. The scale used to evaluate crusting is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.
Time frame: Baseline, Day 1 through Day 14
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac | Self Assessment of Crusting | Day 7 | 0.00 units on a scale | Standard Deviation 0 |
| Duac | Self Assessment of Crusting | Day 1 | 0.00 units on a scale | Standard Deviation 0 |
| Duac | Self Assessment of Crusting | Day 8 | 0.00 units on a scale | Standard Deviation 0 |
| Duac | Self Assessment of Crusting | Day 9 | 0.00 units on a scale | Standard Deviation 0 |
| Duac | Self Assessment of Crusting | Day 3 | 0.00 units on a scale | Standard Deviation 0 |
| Duac | Self Assessment of Crusting | Day 10 | 0.00 units on a scale | Standard Deviation 0 |
| Duac | Self Assessment of Crusting | Baseline | 0.00 units on a scale | Standard Deviation 0 |
| Duac | Self Assessment of Crusting | Day 13 | 0.00 units on a scale | Standard Deviation 0 |
| Duac | Self Assessment of Crusting | Day 6 | 0.00 units on a scale | Standard Deviation 0 |
| Duac | Self Assessment of Crusting | Day 14 | 0.00 units on a scale | Standard Deviation 0 |
| Duac | Self Assessment of Crusting | Day 2 | 0.00 units on a scale | Standard Deviation 0 |
| Epiduo | Self Assessment of Crusting | Day 14 | 0.00 units on a scale | Standard Deviation 0 |
| Epiduo | Self Assessment of Crusting | Baseline | 0.00 units on a scale | Standard Deviation 0 |
| Epiduo | Self Assessment of Crusting | Day 1 | 0.00 units on a scale | Standard Deviation 0 |
| Epiduo | Self Assessment of Crusting | Day 2 | 0.00 units on a scale | Standard Deviation 0 |
| Epiduo | Self Assessment of Crusting | Day 3 | 0.00 units on a scale | Standard Deviation 0 |
| Epiduo | Self Assessment of Crusting | Day 6 | 0.07 units on a scale | Standard Deviation 0.38 |
| Epiduo | Self Assessment of Crusting | Day 7 | 0.04 units on a scale | Standard Deviation 0.19 |
| Epiduo | Self Assessment of Crusting | Day 9 | 0.04 units on a scale | Standard Deviation 0.2 |
| Epiduo | Self Assessment of Crusting | Day 10 | 0.04 units on a scale | Standard Deviation 0.2 |
| Epiduo | Self Assessment of Crusting | Day 13 | 0.00 units on a scale | Standard Deviation 0 |
| Epiduo | Self Assessment of Crusting | Day 8 | 0.04 units on a scale | Standard Deviation 0.2 |
Secondary
Self Assessment of Dryness
The amount of dryness on the left and right cheek of each panelist. The scale used to evaluate dryness is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.
Time frame: Baseline, Day 1 through Day 14
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac | Self Assessment of Dryness | Day 3 | 0.24 units on a scale | Standard Deviation 0.44 |
| Duac | Self Assessment of Dryness | Day 8 | 0.54 units on a scale | Standard Deviation 0.78 |
| Duac | Self Assessment of Dryness | Day 2 | 0.16 units on a scale | Standard Deviation 0.37 |
| Duac | Self Assessment of Dryness | Day 9 | 0.54 units on a scale | Standard Deviation 0.78 |
| Duac | Self Assessment of Dryness | Day 6 | 0.48 units on a scale | Standard Deviation 0.77 |
| Duac | Self Assessment of Dryness | Day 10 | 0.50 units on a scale | Standard Deviation 0.78 |
| Duac | Self Assessment of Dryness | Day 1 | 0.2 units on a scale | Standard Deviation 0.4 |
| Duac | Self Assessment of Dryness | Day 13 | 0.50 units on a scale | Standard Deviation 0.78 |
| Duac | Self Assessment of Dryness | Day 7 | 0.54 units on a scale | Standard Deviation 0.72 |
| Duac | Self Assessment of Dryness | Day 14 | 0.46 units on a scale | Standard Deviation 0.72 |
| Duac | Self Assessment of Dryness | Baseline | 0.24 units on a scale | Standard Deviation 0.44 |
| Epiduo | Self Assessment of Dryness | Day 14 | 0.69 units on a scale | Standard Deviation 1.05 |
| Epiduo | Self Assessment of Dryness | Baseline | 0.30 units on a scale | Standard Deviation 0.54 |
| Epiduo | Self Assessment of Dryness | Day 1 | 0.19 units on a scale | Standard Deviation 0.4 |
| Epiduo | Self Assessment of Dryness | Day 2 | 0.15 units on a scale | Standard Deviation 0.36 |
| Epiduo | Self Assessment of Dryness | Day 3 | 0.2 units on a scale | Standard Deviation 0.4 |
| Epiduo | Self Assessment of Dryness | Day 6 | 0.67 units on a scale | Standard Deviation 0.96 |
| Epiduo | Self Assessment of Dryness | Day 7 | 0.70 units on a scale | Standard Deviation 0.91 |
| Epiduo | Self Assessment of Dryness | Day 8 | 0.81 units on a scale | Standard Deviation 1.02 |
| Epiduo | Self Assessment of Dryness | Day 9 | 0.85 units on a scale | Standard Deviation 1.01 |
| Epiduo | Self Assessment of Dryness | Day 10 | 0.69 units on a scale | Standard Deviation 0.88 |
| Epiduo | Self Assessment of Dryness | Day 13 | 0.73 units on a scale | Standard Deviation 0.96 |
Secondary
Self Assessment of Oiliness
The amount of oiliness on the left and right cheek of each panelist. The scale used to evaluate oiliness is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.
Time frame: Baseline, Day 1 through Day 14
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac | Self Assessment of Oiliness | Day 14 | 0.00 units on a scale | Standard Deviation 0 |
| Duac | Self Assessment of Oiliness | Baseline | 0.12 units on a scale | Standard Deviation 0.33 |
| Duac | Self Assessment of Oiliness | Day 1 | 0.08 units on a scale | Standard Deviation 0.28 |
| Duac | Self Assessment of Oiliness | Day 2 | 0.00 units on a scale | Standard Deviation 0 |
| Duac | Self Assessment of Oiliness | Day 3 | 0.08 units on a scale | Standard Deviation 0.28 |
| Duac | Self Assessment of Oiliness | Day 6 | 0.04 units on a scale | Standard Deviation 0.2 |
| Duac | Self Assessment of Oiliness | Day 7 | 0.00 units on a scale | Standard Deviation 0 |
| Duac | Self Assessment of Oiliness | Day 8 | 0.00 units on a scale | Standard Deviation 0 |
| Duac | Self Assessment of Oiliness | Day 9 | 0.00 units on a scale | Standard Deviation 0 |
| Duac | Self Assessment of Oiliness | Day 10 | 0.00 units on a scale | Standard Deviation 0 |
| Duac | Self Assessment of Oiliness | Day 13 | 0.00 units on a scale | Standard Deviation 0 |
| Epiduo | Self Assessment of Oiliness | Day 13 | 0.12 units on a scale | Standard Deviation 0.43 |
| Epiduo | Self Assessment of Oiliness | Day 7 | 0.07 units on a scale | Standard Deviation 0.27 |
| Epiduo | Self Assessment of Oiliness | Baseline | 0.19 units on a scale | Standard Deviation 0.4 |
| Epiduo | Self Assessment of Oiliness | Day 10 | 0.0 units on a scale | Standard Deviation 0.2 |
| Epiduo | Self Assessment of Oiliness | Day 1 | 0.11 units on a scale | Standard Deviation 0.42 |
| Epiduo | Self Assessment of Oiliness | Day 8 | 0.04 units on a scale | Standard Deviation 0.2 |
| Epiduo | Self Assessment of Oiliness | Day 2 | 0.04 units on a scale | Standard Deviation 0.19 |
| Epiduo | Self Assessment of Oiliness | Day 14 | 0.08 units on a scale | Standard Deviation 0.27 |
| Epiduo | Self Assessment of Oiliness | Day 3 | 0.11 units on a scale | Standard Deviation 0.42 |
| Epiduo | Self Assessment of Oiliness | Day 9 | 0.08 units on a scale | Standard Deviation 0.27 |
| Epiduo | Self Assessment of Oiliness | Day 6 | 0.04 units on a scale | Standard Deviation 0.19 |
Secondary
Self Assessment of Pain
The amount of pain on the left and right cheek of each panelist. The scale used to evaluate pain is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.
Time frame: Baseline, Day 1 through Day 14
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac | Self Assessment of Pain | Day 3 | 0.04 units on a scale | Standard Deviation 0.2 |
| Duac | Self Assessment of Pain | Day 8 | 0.04 units on a scale | Standard Deviation 0.2 |
| Duac | Self Assessment of Pain | Day 2 | 0.04 units on a scale | Standard Deviation 0.2 |
| Duac | Self Assessment of Pain | Day 9 | 0.04 units on a scale | Standard Deviation 0.2 |
| Duac | Self Assessment of Pain | Day 6 | 0.04 units on a scale | Standard Deviation 0.2 |
| Duac | Self Assessment of Pain | Day 10 | 0.04 units on a scale | Standard Deviation 0.2 |
| Duac | Self Assessment of Pain | Day 1 | 0.04 units on a scale | Standard Deviation 0.2 |
| Duac | Self Assessment of Pain | Day 13 | 0.04 units on a scale | Standard Deviation 0.2 |
| Duac | Self Assessment of Pain | Day 7 | 0.04 units on a scale | Standard Deviation 0.2 |
| Duac | Self Assessment of Pain | Day 14 | 0.04 units on a scale | Standard Deviation 0.2 |
| Duac | Self Assessment of Pain | Baseline | 0.00 units on a scale | Standard Deviation 0 |
| Epiduo | Self Assessment of Pain | Day 14 | 0.00 units on a scale | Standard Deviation 0 |
| Epiduo | Self Assessment of Pain | Baseline | 0.00 units on a scale | Standard Deviation 0 |
| Epiduo | Self Assessment of Pain | Day 1 | 0.04 units on a scale | Standard Deviation 0.19 |
| Epiduo | Self Assessment of Pain | Day 2 | 0.00 units on a scale | Standard Deviation 0 |
| Epiduo | Self Assessment of Pain | Day 3 | 0.00 units on a scale | Standard Deviation 0 |
| Epiduo | Self Assessment of Pain | Day 6 | 0.1 units on a scale | Standard Deviation 0.4 |
| Epiduo | Self Assessment of Pain | Day 7 | 0.04 units on a scale | Standard Deviation 0.19 |
| Epiduo | Self Assessment of Pain | Day 8 | 0.04 units on a scale | Standard Deviation 0.2 |
| Epiduo | Self Assessment of Pain | Day 9 | 0.00 units on a scale | Standard Deviation 0 |
| Epiduo | Self Assessment of Pain | Day 10 | 0.00 units on a scale | Standard Deviation 0 |
| Epiduo | Self Assessment of Pain | Day 13 | 0.00 units on a scale | Standard Deviation 0 |
Secondary
Self Assessment of Stinging
The amount of stinging on the left and right cheek of each panelist. The scale used to evaluate stinging is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of stinging were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.
Time frame: Baseline, Day 1 through Day 14
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac | Self Assessment of Stinging | Day 3 | 0.12 units on a scale | Standard Deviation 0.44 |
| Duac | Self Assessment of Stinging | Day 8 | 0.17 units on a scale | Standard Deviation 0.48 |
| Duac | Self Assessment of Stinging | Day 2 | 0.08 units on a scale | Standard Deviation 0.28 |
| Duac | Self Assessment of Stinging | Day 9 | 0.13 units on a scale | Standard Deviation 0.45 |
| Duac | Self Assessment of Stinging | Day 6 | 0.1 units on a scale | Standard Deviation 0.4 |
| Duac | Self Assessment of Stinging | Day 10 | 0.13 units on a scale | Standard Deviation 0.45 |
| Duac | Self Assessment of Stinging | Day 1 | 0.08 units on a scale | Standard Deviation 0.28 |
| Duac | Self Assessment of Stinging | Day 13 | 0.13 units on a scale | Standard Deviation 0.34 |
| Duac | Self Assessment of Stinging | Day 7 | 0.17 units on a scale | Standard Deviation 0.48 |
| Duac | Self Assessment of Stinging | Day 14 | 0.08 units on a scale | Standard Deviation 0.28 |
| Duac | Self Assessment of Stinging | Baseline | 0.00 units on a scale | Standard Deviation 0 |
| Epiduo | Self Assessment of Stinging | Day 14 | 0.12 units on a scale | Standard Deviation 0.43 |
| Epiduo | Self Assessment of Stinging | Baseline | 0.00 units on a scale | Standard Deviation 0 |
| Epiduo | Self Assessment of Stinging | Day 1 | 0.00 units on a scale | Standard Deviation 0 |
| Epiduo | Self Assessment of Stinging | Day 2 | 0.00 units on a scale | Standard Deviation 0 |
| Epiduo | Self Assessment of Stinging | Day 3 | 0.04 units on a scale | Standard Deviation 0.19 |
| Epiduo | Self Assessment of Stinging | Day 6 | 0.4 units on a scale | Standard Deviation 0.8 |
| Epiduo | Self Assessment of Stinging | Day 7 | 0.30 units on a scale | Standard Deviation 0.67 |
| Epiduo | Self Assessment of Stinging | Day 8 | 0.35 units on a scale | Standard Deviation 0.69 |
| Epiduo | Self Assessment of Stinging | Day 9 | 0.15 units on a scale | Standard Deviation 0.54 |
| Epiduo | Self Assessment of Stinging | Day 10 | 0.12 units on a scale | Standard Deviation 0.43 |
| Epiduo | Self Assessment of Stinging | Day 13 | 0.19 units on a scale | Standard Deviation 0.57 |
Secondary
Self Assessment of Texture (Roughness)
The amount of roughness on the left and right cheek of each panelist. The scale used to evaluate roughness is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.
Time frame: Baseline, Day 1 through Day 14
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac | Self Assessment of Texture (Roughness) | Day 3 | 0.32 units on a scale | Standard Deviation 0.69 |
| Duac | Self Assessment of Texture (Roughness) | Day 8 | 0.25 units on a scale | Standard Deviation 0.61 |
| Duac | Self Assessment of Texture (Roughness) | Day 2 | 0.16 units on a scale | Standard Deviation 0.47 |
| Duac | Self Assessment of Texture (Roughness) | Day 9 | 0.29 units on a scale | Standard Deviation 0.69 |
| Duac | Self Assessment of Texture (Roughness) | Day 6 | 0.28 units on a scale | Standard Deviation 0.68 |
| Duac | Self Assessment of Texture (Roughness) | Day 10 | 0.29 units on a scale | Standard Deviation 0.69 |
| Duac | Self Assessment of Texture (Roughness) | Day 1 | 0.20 units on a scale | Standard Deviation 0.5 |
| Duac | Self Assessment of Texture (Roughness) | Day 13 | 0.33 units on a scale | Standard Deviation 0.7 |
| Duac | Self Assessment of Texture (Roughness) | Day 7 | 0.33 units on a scale | Standard Deviation 0.76 |
| Duac | Self Assessment of Texture (Roughness) | Day 14 | 0.29 units on a scale | Standard Deviation 0.69 |
| Duac | Self Assessment of Texture (Roughness) | Baseline | 0.28 units on a scale | Standard Deviation 0.54 |
| Epiduo | Self Assessment of Texture (Roughness) | Day 14 | 0.15 units on a scale | Standard Deviation 0.46 |
| Epiduo | Self Assessment of Texture (Roughness) | Baseline | 0.15 units on a scale | Standard Deviation 0.36 |
| Epiduo | Self Assessment of Texture (Roughness) | Day 1 | 0.07 units on a scale | Standard Deviation 0.27 |
| Epiduo | Self Assessment of Texture (Roughness) | Day 2 | 0.07 units on a scale | Standard Deviation 0.27 |
| Epiduo | Self Assessment of Texture (Roughness) | Day 3 | 0.07 units on a scale | Standard Deviation 0.27 |
| Epiduo | Self Assessment of Texture (Roughness) | Day 6 | 0.33 units on a scale | Standard Deviation 0.78 |
| Epiduo | Self Assessment of Texture (Roughness) | Day 7 | 0.19 units on a scale | Standard Deviation 0.56 |
| Epiduo | Self Assessment of Texture (Roughness) | Day 8 | 0.3 units on a scale | Standard Deviation 0.7 |
| Epiduo | Self Assessment of Texture (Roughness) | Day 9 | 0.15 units on a scale | Standard Deviation 0.46 |
| Epiduo | Self Assessment of Texture (Roughness) | Day 10 | 0.15 units on a scale | Standard Deviation 0.46 |
| Epiduo | Self Assessment of Texture (Roughness) | Day 13 | 0.12 units on a scale | Standard Deviation 0.43 |
Secondary
Skin Hydration
The ability of an alternating current to flow through the stratum corneum is an indirect measure of its water content. The value recorded is expressed in microsiemens. Higher values indicate greater levels of skin hydration. Test results were compared to measurements from the other side of the face, which was not treated instead of referring to a normal range. A normal range does not exist for this measurement. Instead, the non-treated side of the face was used as a control to determine the normal level of skin hydration.
Time frame: Baseline, 4 hrs. post 1st Treatment, Days 3, 7, and 14
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac | Skin Hydration | 4 hrs Post 1st Treatment | 323.47 Microsiemens | Standard Deviation 154.3 |
| Duac | Skin Hydration | Day 7 | 385.91 Microsiemens | Standard Deviation 156.69 |
| Duac | Skin Hydration | Day 3 | 420.97 Microsiemens | Standard Deviation 122.6 |
| Duac | Skin Hydration | Day 14 | 401.98 Microsiemens | Standard Deviation 156.08 |
| Duac | Skin Hydration | Baseline | 378.06 Microsiemens | Standard Deviation 131.08 |
| Epiduo | Skin Hydration | Day 14 | 418.51 Microsiemens | Standard Deviation 139.64 |
| Epiduo | Skin Hydration | Baseline | 392.09 Microsiemens | Standard Deviation 162.16 |
| Epiduo | Skin Hydration | 4 hrs Post 1st Treatment | 415.90 Microsiemens | Standard Deviation 197.57 |
| Epiduo | Skin Hydration | Day 3 | 465.25 Microsiemens | Standard Deviation 175.65 |
| Epiduo | Skin Hydration | Day 7 | 414.77 Microsiemens | Standard Deviation 154.46 |
Secondary
Skin Moisture and Hydration
To assess skin moisture and hydration using transepidermal water loss (TEWL). Results are measured on a continuous scale. Higher values indicate greater water loss/ lower skin moisture levels. Evaporative water loss measurements provide an instrumental assessment of skin barrier function(one of the layers of the skin. Damage leads to a disruption of the barrier that is accompanied by elevated water loss rates and affects skin moisture and hydration. Higher values indicate greater water loss.
Time frame: Baseline, Days 3, 7, and 14
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac | Skin Moisture and Hydration | Baseline | 11.50 TEWL rates (gm/m2/hr) | Standard Deviation 3.65 |
| Duac | Skin Moisture and Hydration | Day 3 | 11.38 TEWL rates (gm/m2/hr) | Standard Deviation 2.49 |
| Duac | Skin Moisture and Hydration | Day 7 | 14.51 TEWL rates (gm/m2/hr) | Standard Deviation 3.65 |
| Duac | Skin Moisture and Hydration | Day 14 | 13.36 TEWL rates (gm/m2/hr) | Standard Deviation 3.33 |
| Epiduo | Skin Moisture and Hydration | Day 14 | 19.28 TEWL rates (gm/m2/hr) | Standard Deviation 8.1 |
| Epiduo | Skin Moisture and Hydration | Baseline | 13.07 TEWL rates (gm/m2/hr) | Standard Deviation 5.06 |
| Epiduo | Skin Moisture and Hydration | Day 7 | 21.65 TEWL rates (gm/m2/hr) | Standard Deviation 8.66 |
| Epiduo | Skin Moisture and Hydration | Day 3 | 15.85 TEWL rates (gm/m2/hr) | Standard Deviation 9.12 |