Acne Vulgaris
Conditions
Keywords
Healthy volunteers
Brief summary
This is a single-blind (blinded expert grader) study that will enroll 25-30 healthy volunteers without facial acne. On 1 side of the face, the subject will apply 1 of the 2 test products, clindamycin and benzoyl peroxide 5% or clindamycin phosphate and benzoyl peroxide 2.5% and the other side of the face will remain non-treated to serve as a control.
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, clindamycin and benzoyl peroxide 5%) or clindamycin and benzoyl peroxide 2.5%) and the other side of the face will remain non-treated to serve as a control. Approximately 25-30 male and female healthy subjects without facial acne, aged 18 to 45, will be randomly assigned to each product. The eligible subjects (screened 3 days prior to randomization) who qualify will be entered into a 2-week treatment phase. The once-daily applications for the clindamycin and benzoyl peroxide 5%and clindamycin phosphate and benzoyl peroxide 2.5%) will be supervised at the site, Monday through Friday of each week. Subjects will apply the study product at home on Saturdays and Sundays and record the times of application on a diary card. A blinded expert grader will rate comparative product tolerance in terms of erythema and dryness on each week day (excluding Saturdays and Sundays) during the study before study product is applied. Instruments will be used to measure transepidermal water loss (TEWL) to assess skin moisture in order to evaluate product mildness. Instrumentation measurements of skin surface conductance will be utilized to evaluate product performance in terms of level of skin hydration. Subjects will complete questionnaires and all adverse events will be recorded.
Interventions
DRUGClindamycin and BPO 5% gel
Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide (BPO) 5% gel.
DRUGClindamycin phosphate and benzoyl peroxide 2.5% gel.
Once daily application of clindamycin phosphate and benzoyl peroxide (BPO) 2.5% gel
Sponsors
GlaxoSmithKline
Stiefel, a GSK Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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. * Male and female subjects aged from 18 to 45 years at time of consent. * 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 not change brands of makeup or razor and facial shave product during the study. * Is willing to refrain from using any facial product on the face other than study products and their normal makeup or razor and facial shave product for the duration of the study. * Able to complete the study and to comply with study instructions. * Sexually active females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product
Exclusion criteria
* Female subjects who are pregnant, trying to become pregnant, or breast feeding. * 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. * Use of topical retinoids or related agents for the treatment of acne or photoaging in the preceding 6 months. * Any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's facial appearance. * Has known sensitivities or allergies to cosmetics, soaps, fragrances, or any of the ingredients in the test products. * Is currently going through menopause and experiencing hot flashes. * Received any investigational drug within 30 days of study day 0 or who are scheduled to receive an investigational drug other than the study product during the study. * Currently using any medication, which in the opinion of the investigator may affect the evaluation of the study product or place the subject at undue risk (including but not limited to asthma medications, oral steroids, rifampin, anticonvulsants, St. John's wart). * Currently taking any topical or oral erythromycin-containing products. * History of regional enteritis, ulcerative colitis, or antibiotic-associated colitis. * Currently suffering from any disease or condition, which in the opinion of the investigator may affect the evaluation of the study product or place the subject at undue risk. * Live in the same household as currently enrolled subjects. * Employees of investigator/ clinical research organization (CRO) or Stiefel, a GSK Company involved in the study, or an immediate family member (partner, offspring, parents, siblings or sibling's offspring) of an employee involved in the study. * 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 |
|---|---|---|
| Erythema (Redness) | 14 days | Compare tolerability of clindamycin and benzoyl peroxide (BPO) 5% and clindamycin phosphate and benzoyl peroxide 2.5% using visual assessments by an independent blinded grader. Erythema (redness) was evaluated using the following scale: Erythema 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 | 14 days | Visual Dryness was evaluated using the following scale: Grade 0 = None 2 = Slight flaking 4 = Moderate flaking/scaling 6 = Marked scaling / slight fissuring 8 Severe scaling, fissuring |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Tolerability - Burning | 2 weeks | At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, pain, and dryness in this questionnaire. Each symptom was rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe. The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of burning are presented here. |
| Subject Tolerability - Stinging | 2 weeks | At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None,1 - Slight,2 - Moderate, or 3 - Severe. The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of stinging are presented here. |
| Subject Assessment - Dryness | 2 weeks | At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe. The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of dryness are presented here. |
| Subject Assessment - Roughness | 2 weeks | At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, roughness, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe. The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of roughness are presented here. |
| Skin Moisture and Hydration | 14 days | To assess skin moisture and hydration using transepidermal water loss (TEWL). Results are measured on a continuous scale as grams per meters squared (m\^2) per hour. 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. |
| Subject Assessment - Crusting | 2 Weeks | At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate crusting, burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe. The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of crusting are presented here. |
| Subject Assessment - Blistering | 2 Weeks | At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate blistering, burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe. The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of blistering are presented here. |
| Subject Assessment - Oiliness | 2 Weeks | At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate oiliness, burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe. The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of oiliness are presented here. |
| Subject Assessment - Pain | 2 Weeks | At each visit, panelists were supplied a self-assessment questionnaire, which included assessment of pain. Subjects were asked to evaluate burning, stinging, pain, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe. The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of pain are presented here. |
| Changes in the Skin Surface Hydration | 14 days | 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. Enrollment started: 11 Aug 2009 Last patient last visit: 1 Sep 2009
Pre-assignment details
Subjects who met inclusion and exclusion criteria and are willing to participate in the study were required to undergo a 3-day screening period where they will stop the use of all facial products on their face. Subjects were required to use soap free cleanser for washing their face and may apply their normal makeup.
Participants by arm
| Arm | Count |
|---|---|
| Clindamycin and BPO 5% Gel Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel. | 17 |
| Clindamycin Phosphate and BPO 2.5% Gel Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel. | 19 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Clindamycin and BPO 5% Gel | Clindamycin Phosphate and BPO 2.5% Gel | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 19 Participants | 35 Participants |
| Region of Enrollment United States | 17 participants | 19 participants | 36 participants |
| Sex: Female, Male Female | 11 Participants | 15 Participants | 26 Participants |
| Sex: Female, Male Male | 6 Participants | 4 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 17 | 3 / 19 |
| serious Total, serious adverse events | 0 / 17 | 0 / 19 |
Outcome results
Primary
Erythema (Redness)
Compare tolerability of clindamycin and benzoyl peroxide (BPO) 5% and clindamycin phosphate and benzoyl peroxide 2.5% using visual assessments by an independent blinded grader. Erythema (redness) was evaluated using the following scale: Erythema 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: 14 days
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clindamycin and BPO 5% Gel | Erythema (Redness) | Day 3 | 1.27 units on a scale | Standard Deviation 0.96 |
| Clindamycin and BPO 5% Gel | Erythema (Redness) | Day 8 | 1.39 units on a scale | Standard Deviation 0.86 |
| Clindamycin and BPO 5% Gel | Erythema (Redness) | Day 2 | 1.45 units on a scale | Standard Deviation 1.18 |
| Clindamycin and BPO 5% Gel | Erythema (Redness) | Day 9 | 1.38 units on a scale | Standard Deviation 1 |
| Clindamycin and BPO 5% Gel | Erythema (Redness) | Day 6 | 1.55 units on a scale | Standard Deviation 1.15 |
| Clindamycin and BPO 5% Gel | Erythema (Redness) | Day 10 | 1.78 units on a scale | Standard Deviation 1.26 |
| Clindamycin and BPO 5% Gel | Erythema (Redness) | Day 1 | 1.42 units on a scale | Standard Deviation 1.32 |
| Clindamycin and BPO 5% Gel | Erythema (Redness) | Day 13 | 1.34 units on a scale | Standard Deviation 1.03 |
| Clindamycin and BPO 5% Gel | Erythema (Redness) | Day 7 | 1.72 units on a scale | Standard Deviation 1.14 |
| Clindamycin and BPO 5% Gel | Erythema (Redness) | Day 14 | 1.51 units on a scale | Standard Deviation 1.06 |
| Clindamycin and BPO 5% Gel | Erythema (Redness) | Day 0 | 0.94 units on a scale | Standard Deviation 0.83 |
| Clindamycin Phosphate and BPO 2.5% Gel | Erythema (Redness) | Day 14 | 1.82 units on a scale | Standard Deviation 1.18 |
| Clindamycin Phosphate and BPO 2.5% Gel | Erythema (Redness) | Day 0 | 1.05 units on a scale | Standard Deviation 0.78 |
| Clindamycin Phosphate and BPO 2.5% Gel | Erythema (Redness) | Day 1 | 1.24 units on a scale | Standard Deviation 0.7 |
| Clindamycin Phosphate and BPO 2.5% Gel | Erythema (Redness) | Day 2 | 1.49 units on a scale | Standard Deviation 1.33 |
| Clindamycin Phosphate and BPO 2.5% Gel | Erythema (Redness) | Day 3 | 1.36 units on a scale | Standard Deviation 1.14 |
| Clindamycin Phosphate and BPO 2.5% Gel | Erythema (Redness) | Day 6 | 1.87 units on a scale | Standard Deviation 1.23 |
| Clindamycin Phosphate and BPO 2.5% Gel | Erythema (Redness) | Day 7 | 1.88 units on a scale | Standard Deviation 1.25 |
| Clindamycin Phosphate and BPO 2.5% Gel | Erythema (Redness) | Day 8 | 1.70 units on a scale | Standard Deviation 1.38 |
| Clindamycin Phosphate and BPO 2.5% Gel | Erythema (Redness) | Day 9 | 1.82 units on a scale | Standard Deviation 1.38 |
| Clindamycin Phosphate and BPO 2.5% Gel | Erythema (Redness) | Day 10 | 1.72 units on a scale | Standard Deviation 1.18 |
| Clindamycin Phosphate and BPO 2.5% Gel | Erythema (Redness) | Day 13 | 1.82 units on a scale | Standard Deviation 1.44 |
p-value: >0.05Kruskal-Wallis
Primary
Skin Dryness
Visual Dryness was evaluated using the following scale: Grade 0 = None 2 = Slight flaking 4 = Moderate flaking/scaling 6 = Marked scaling / slight fissuring 8 Severe scaling, fissuring
Time frame: 14 days
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clindamycin and BPO 5% Gel | Skin Dryness | Day 0 | 0.06 units on a scale | Standard Deviation 0.24 |
| Clindamycin and BPO 5% Gel | Skin Dryness | Day 1 | 0.05 units on a scale | Standard Deviation 0.05 |
| Clindamycin and BPO 5% Gel | Skin Dryness | Day 2 | 0.05 units on a scale | Standard Deviation 0.05 |
| Clindamycin and BPO 5% Gel | Skin Dryness | Day 3 | 0.27 units on a scale | Standard Deviation 0.55 |
| Clindamycin and BPO 5% Gel | Skin Dryness | Day 6 | 0.29 units on a scale | Standard Deviation 0.55 |
| Clindamycin and BPO 5% Gel | Skin Dryness | Day 7 | 0.32 units on a scale | Standard Deviation 0.54 |
| Clindamycin and BPO 5% Gel | Skin Dryness | Day 8 | 0.40 units on a scale | Standard Deviation 0.59 |
| Clindamycin and BPO 5% Gel | Skin Dryness | Day 9 | 0.35 units on a scale | Standard Deviation 0.56 |
| Clindamycin and BPO 5% Gel | Skin Dryness | Day 10 | 0.47 units on a scale | Standard Deviation 1.04 |
| Clindamycin and BPO 5% Gel | Skin Dryness | Day 13 | 0.76 units on a scale | Standard Deviation 1.33 |
| Clindamycin and BPO 5% Gel | Skin Dryness | Day 14 | 0.62 units on a scale | Standard Deviation 1.05 |
| Clindamycin Phosphate and BPO 2.5% Gel | Skin Dryness | Day 13 | 0.28 units on a scale | Standard Deviation 0.46 |
| Clindamycin Phosphate and BPO 2.5% Gel | Skin Dryness | Day 0 | 0.05 units on a scale | Standard Deviation 0.23 |
| Clindamycin Phosphate and BPO 2.5% Gel | Skin Dryness | Day 10 | 0.36 units on a scale | Standard Deviation 0.99 |
| Clindamycin Phosphate and BPO 2.5% Gel | Skin Dryness | Day 7 | 0.15 units on a scale | Standard Deviation 0.45 |
| Clindamycin Phosphate and BPO 2.5% Gel | Skin Dryness | Day 1 | 0.15 units on a scale | Standard Deviation 0.3 |
| Clindamycin Phosphate and BPO 2.5% Gel | Skin Dryness | Day 8 | 0.15 units on a scale | Standard Deviation 0.32 |
| Clindamycin Phosphate and BPO 2.5% Gel | Skin Dryness | Day 2 | 0.37 units on a scale | Standard Deviation 0.66 |
| Clindamycin Phosphate and BPO 2.5% Gel | Skin Dryness | Day 14 | 0.31 units on a scale | Standard Deviation 0.54 |
| Clindamycin Phosphate and BPO 2.5% Gel | Skin Dryness | Day 3 | 0.22 units on a scale | Standard Deviation 0.37 |
| Clindamycin Phosphate and BPO 2.5% Gel | Skin Dryness | Day 9 | 0.15 units on a scale | Standard Deviation 0.3 |
| Clindamycin Phosphate and BPO 2.5% Gel | Skin Dryness | Day 6 | 0.24 units on a scale | Standard Deviation 0.53 |
p-value: >0.05Kruskal-Wallis
Secondary
Changes in the Skin Surface 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: 14 days
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clindamycin and BPO 5% Gel | Changes in the Skin Surface Hydration | Day 0 | 546.40 microsiemens | Standard Deviation 185.75 |
| Clindamycin and BPO 5% Gel | Changes in the Skin Surface Hydration | Day 3 | 572.39 microsiemens | Standard Deviation 200.31 |
| Clindamycin and BPO 5% Gel | Changes in the Skin Surface Hydration | 4 Hours Post 1st Treatment | 554.00 microsiemens | Standard Deviation 202.94 |
| Clindamycin and BPO 5% Gel | Changes in the Skin Surface Hydration | Day 14 | 361.59 microsiemens | Standard Deviation 177.01 |
| Clindamycin and BPO 5% Gel | Changes in the Skin Surface Hydration | Day 7 | 484.94 microsiemens | Standard Deviation 212.56 |
| Clindamycin Phosphate and BPO 2.5% Gel | Changes in the Skin Surface Hydration | Day 14 | 354.46 microsiemens | Standard Deviation 144.06 |
| Clindamycin Phosphate and BPO 2.5% Gel | Changes in the Skin Surface Hydration | Day 7 | 413.51 microsiemens | Standard Deviation 131.31 |
| Clindamycin Phosphate and BPO 2.5% Gel | Changes in the Skin Surface Hydration | Day 0 | 478.02 microsiemens | Standard Deviation 170.88 |
| Clindamycin Phosphate and BPO 2.5% Gel | Changes in the Skin Surface Hydration | 4 Hours Post 1st Treatment | 430.78 microsiemens | Standard Deviation 158.98 |
| Clindamycin Phosphate and BPO 2.5% Gel | Changes in the Skin Surface Hydration | Day 3 | 529.96 microsiemens | Standard Deviation 124.88 |
p-value: >0.05Tukey-Kramer Multiple Comparisons Test
Secondary
Skin Moisture and Hydration
To assess skin moisture and hydration using transepidermal water loss (TEWL). Results are measured on a continuous scale as grams per meters squared (m\^2) per hour. 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.
Time frame: 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clindamycin and BPO 5% Gel | Skin Moisture and Hydration | Day 3 | 11.98 grams/m^2/hour | Standard Deviation 4.18 |
| Clindamycin and BPO 5% Gel | Skin Moisture and Hydration | Day 14 | 13.94 grams/m^2/hour | Standard Deviation 4.1 |
| Clindamycin and BPO 5% Gel | Skin Moisture and Hydration | Day 7 | 13.01 grams/m^2/hour | Standard Deviation 3.16 |
| Clindamycin and BPO 5% Gel | Skin Moisture and Hydration | Day 0 | 10.82 grams/m^2/hour | Standard Deviation 4.15 |
| Clindamycin Phosphate and BPO 2.5% Gel | Skin Moisture and Hydration | Day 7 | 11.36 grams/m^2/hour | Standard Deviation 2.91 |
| Clindamycin Phosphate and BPO 2.5% Gel | Skin Moisture and Hydration | Day 3 | 10.84 grams/m^2/hour | Standard Deviation 3.46 |
| Clindamycin Phosphate and BPO 2.5% Gel | Skin Moisture and Hydration | Day 0 | 9.71 grams/m^2/hour | Standard Deviation 3.14 |
| Clindamycin Phosphate and BPO 2.5% Gel | Skin Moisture and Hydration | Day 14 | 13.59 grams/m^2/hour | Standard Deviation 4.68 |
p-value: >0.05Dunn's Multiple Comparisons Test
Secondary
Subject Assessment - Blistering
At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate blistering, burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe. The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of blistering are presented here.
Time frame: 2 Weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clindamycin and BPO 5% Gel | Subject Assessment - Blistering | Day 0 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Blistering | Day 7 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Blistering | Day 8 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Blistering | Day 1 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Blistering | Day 9 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Blistering | Day 10 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Blistering | Day 2 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Blistering | Day 13 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Blistering | Day 3 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Blistering | Day 14 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Blistering | Day 6 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Blistering | Day 14 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Blistering | Day 6 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Blistering | Day 9 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Blistering | Day 1 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Blistering | Day 0 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Blistering | Day 2 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Blistering | Day 3 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Blistering | Day 7 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Blistering | Day 8 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Blistering | Day 10 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Blistering | Day 13 | 0.00 units on a scale | Standard Deviation 0 |
Secondary
Subject Assessment - Crusting
At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate crusting, burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe. The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of crusting are presented here.
Time frame: 2 Weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clindamycin and BPO 5% Gel | Subject Assessment - Crusting | Day 9 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Crusting | Day 0 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Crusting | Day 1 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Crusting | Day 2 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Crusting | Day 3 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Crusting | Day 6 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Crusting | Day 7 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Crusting | Day 8 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Crusting | Day 10 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Crusting | Day 13 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Crusting | Day 14 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Crusting | Day 10 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Crusting | Day 7 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Crusting | Day 0 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Crusting | Day 14 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Crusting | Day 1 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Crusting | Day 8 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Crusting | Day 2 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Crusting | Day 9 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Crusting | Day 3 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Crusting | Day 13 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Crusting | Day 6 | 0.00 units on a scale | Standard Deviation 0 |
Secondary
Subject Assessment - Dryness
At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe. The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of dryness are presented here.
Time frame: 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clindamycin and BPO 5% Gel | Subject Assessment - Dryness | Day 9 | 0.2 units on a scale | Standard Deviation 0.5 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Dryness | Day 0 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Dryness | Day 1 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Dryness | Day 2 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Dryness | Day 3 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Dryness | Day 6 | 0.06 units on a scale | Standard Deviation 0.24 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Dryness | Day 7 | 0.12 units on a scale | Standard Deviation 0.49 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Dryness | Day 8 | 0.12 units on a scale | Standard Deviation 0.49 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Dryness | Day 10 | 0.24 units on a scale | Standard Deviation 0.56 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Dryness | Day 13 | 0.35 units on a scale | Standard Deviation 0.7 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Dryness | Day 14 | 0.24 units on a scale | Standard Deviation 0.56 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Dryness | Day 10 | 0.16 units on a scale | Standard Deviation 0.5 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Dryness | Day 7 | 0.21 units on a scale | Standard Deviation 0.54 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Dryness | Day 0 | 0.26 units on a scale | Standard Deviation 0.56 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Dryness | Day 14 | 0.21 units on a scale | Standard Deviation 0.63 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Dryness | Day 1 | 0.26 units on a scale | Standard Deviation 0.56 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Dryness | Day 8 | 0.16 units on a scale | Standard Deviation 0.5 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Dryness | Day 2 | 0.21 units on a scale | Standard Deviation 0.54 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Dryness | Day 9 | 0.16 units on a scale | Standard Deviation 0.5 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Dryness | Day 3 | 0.11 units on a scale | Standard Deviation 0.46 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Dryness | Day 13 | 0.16 units on a scale | Standard Deviation 0.5 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Dryness | Day 6 | 0.11 units on a scale | Standard Deviation 0.32 |
Secondary
Subject Assessment - Oiliness
At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate oiliness, burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe. The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of oiliness are presented here.
Time frame: 2 Weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clindamycin and BPO 5% Gel | Subject Assessment - Oiliness | Day 7 | 0.06 units on a scale | Standard Deviation 0.24 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Oiliness | Day 0 | 0.18 units on a scale | Standard Deviation 0.53 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Oiliness | Day 8 | 0.06 units on a scale | Standard Deviation 0.24 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Oiliness | Day 2 | 0.06 units on a scale | Standard Deviation 0.24 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Oiliness | Day 9 | 0.06 units on a scale | Standard Deviation 0.24 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Oiliness | Day 3 | 0.12 units on a scale | Standard Deviation 0.33 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Oiliness | Day 10 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Oiliness | Day 13 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Oiliness | Day 6 | 0.06 units on a scale | Standard Deviation 0.24 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Oiliness | Day 14 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Oiliness | Day 1 | 0.18 units on a scale | Standard Deviation 0.39 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Oiliness | Day 14 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Oiliness | Day 10 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Oiliness | Day 0 | 0.16 units on a scale | Standard Deviation 0.37 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Oiliness | Day 1 | 0.05 units on a scale | Standard Deviation 0.23 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Oiliness | Day 3 | 0.11 units on a scale | Standard Deviation 0.46 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Oiliness | Day 6 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Oiliness | Day 7 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Oiliness | Day 8 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Oiliness | Day 9 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Oiliness | Day 13 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Oiliness | Day 2 | 0.00 units on a scale | Standard Deviation 0 |
Secondary
Subject Assessment - Pain
At each visit, panelists were supplied a self-assessment questionnaire, which included assessment of pain. Subjects were asked to evaluate burning, stinging, pain, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe. The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of pain are presented here.
Time frame: 2 Weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clindamycin and BPO 5% Gel | Subject Assessment - Pain | Day 3 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Pain | Day 8 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Pain | Day 2 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Pain | Day 9 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Pain | Day 6 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Pain | Day 10 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Pain | Day 1 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Pain | Day 13 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Pain | Day 7 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Pain | Day 14 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Pain | Day 0 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Pain | Day 14 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Pain | Day 0 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Pain | Day 1 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Pain | Day 2 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Pain | Day 3 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Pain | Day 6 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Pain | Day 7 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Pain | Day 8 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Pain | Day 9 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Pain | Day 10 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Pain | Day 13 | 0.00 units on a scale | Standard Deviation 0 |
Secondary
Subject Assessment - Roughness
At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, roughness, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe. The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of roughness are presented here.
Time frame: 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clindamycin and BPO 5% Gel | Subject Assessment - Roughness | Day 1 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Roughness | Day 8 | 0.06 units on a scale | Standard Deviation 0.24 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Roughness | Day 3 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Roughness | Day 9 | 0.18 units on a scale | Standard Deviation 0.53 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Roughness | Day 0 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Roughness | Day 10 | 0.12 units on a scale | Standard Deviation 0.49 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Roughness | Day 2 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Roughness | Day 13 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Roughness | Day 7 | 0.06 units on a scale | Standard Deviation 0.24 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Roughness | Day 14 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Assessment - Roughness | Day 6 | 0.06 units on a scale | Standard Deviation 0.24 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Roughness | Day 14 | 0.05 units on a scale | Standard Deviation 0.23 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Roughness | Day 0 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Roughness | Day 1 | 0.05 units on a scale | Standard Deviation 0.23 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Roughness | Day 2 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Roughness | Day 3 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Roughness | Day 6 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Roughness | Day 7 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Roughness | Day 8 | 0.05 units on a scale | Standard Deviation 0.23 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Roughness | Day 9 | 0.05 units on a scale | Standard Deviation 0.23 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Roughness | Day 10 | 0.05 units on a scale | Standard Deviation 0.23 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Assessment - Roughness | Day 13 | 0.05 units on a scale | Standard Deviation 0.23 |
Secondary
Subject Tolerability - Burning
At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, pain, and dryness in this questionnaire. Each symptom was rated with the following scale: 0 - None, 1 - Slight, 2 - Moderate, or 3 - Severe. The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of burning are presented here.
Time frame: 2 weeks
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clindamycin and BPO 5% Gel | Subject Tolerability - Burning | Day 3 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Tolerability - Burning | Day 8 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Tolerability - Burning | Day 2 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Tolerability - Burning | Day 9 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Tolerability - Burning | Day 6 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Tolerability - Burning | Day 10 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Tolerability - Burning | Day 1 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Tolerability - Burning | Day 13 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Tolerability - Burning | Day 7 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Tolerability - Burning | Day 14 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Tolerability - Burning | Day 0 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Tolerability - Burning | Day 14 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Tolerability - Burning | Day 0 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Tolerability - Burning | Day 1 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Tolerability - Burning | Day 2 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Tolerability - Burning | Day 3 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Tolerability - Burning | Day 6 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Tolerability - Burning | Day 7 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Tolerability - Burning | Day 8 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Tolerability - Burning | Day 9 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Tolerability - Burning | Day 10 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Tolerability - Burning | Day 13 | 0.00 units on a scale | Standard Deviation 0 |
Secondary
Subject Tolerability - Stinging
At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 - None,1 - Slight,2 - Moderate, or 3 - Severe. The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of stinging are presented here.
Time frame: 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clindamycin and BPO 5% Gel | Subject Tolerability - Stinging | Day 3 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Tolerability - Stinging | Day 8 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Tolerability - Stinging | Day 2 | 0.06 units on a scale | Standard Deviation 0.24 |
| Clindamycin and BPO 5% Gel | Subject Tolerability - Stinging | Day 9 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Tolerability - Stinging | Day 6 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Tolerability - Stinging | Day 10 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Tolerability - Stinging | Day 1 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Tolerability - Stinging | Day 13 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Tolerability - Stinging | Day 7 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Tolerability - Stinging | Day 14 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin and BPO 5% Gel | Subject Tolerability - Stinging | Day 0 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Tolerability - Stinging | Day 14 | 0.11 units on a scale | Standard Deviation 0.46 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Tolerability - Stinging | Day 0 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Tolerability - Stinging | Day 1 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Tolerability - Stinging | Day 2 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Tolerability - Stinging | Day 3 | 0.05 units on a scale | Standard Deviation 0.23 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Tolerability - Stinging | Day 6 | 0.05 units on a scale | Standard Deviation 0.23 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Tolerability - Stinging | Day 7 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Tolerability - Stinging | Day 8 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Tolerability - Stinging | Day 9 | 0.00 units on a scale | Standard Deviation 0 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Tolerability - Stinging | Day 10 | 0.05 units on a scale | Standard Deviation 0.23 |
| Clindamycin Phosphate and BPO 2.5% Gel | Subject Tolerability - Stinging | Day 13 | 0.00 units on a scale | Standard Deviation 0 |