Skin Diseases
Conditions
Brief summary
5 Day study to assess how quickly a topical acne product begins to work.
Interventions
DRUG3% Benzoyl Peroxide
Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
DRUG3% Benzoyl Peroxide Placebo
The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
DRUGNeutrogena Rapid Clear®
A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Fitzpatrick Skin Type I - V. 3. Male or female aged from 12 to 45 years, inclusive, at time of consent. 4. Mild to moderate facial acne vulgaris as determined by the Investigator, with a minimum of 10 inflammatory lesions (papules plus pustules, including nasal lesions) and a minimum of 10 non-inflammatory lesions (open and closed comedones, including nasal lesions). 5. Three appropriate and evaluable target lesions, as judged by the Investigator. 6. Able to complete the study and to comply with study instructions. 7. 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. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant; including perimenopausal women who are less than 2 years from their last menses. Acceptable contraceptive methods include the following: * Hormonal contraception, including oral, injectable, or implantable methods started at least 2 months prior to screening. If hormonal contraception was started less than 2 months prior to screening, then a form of nonhormonal contraception should be added until the third continuous month of hormonal contraception has been completed. * Two forms of reliable nonhormonal contraception, to include the use of either an intrauterine device plus a reliable barrier method or 2 reliable barrier methods. Reliable barrier methods include condoms or diaphragms. A cervical cap is also a reliable barrier method, provided that the female participant has never given birth naturally. The combined use of a condom and spermicide constitute 2 forms of acceptable nonhormonal contraception, provided that they are both used properly. The use of spermicide alone and the improper use of condoms are inferior methods of contraception. Participants with surgical sterilization, including tubal sterilization or partner's vasectomy, must use a form of nonhormonal contraception. A barrier method or sterilization plus spermicide is acceptable. * Women who are not currently sexually active must agree to use a medically accepted method of contraception should they become sexually active while participating in the study.
Exclusion criteria
1. Has any nodulocystic lesions at the baseline evaluation. 2. Female who is pregnant, trying to become pregnant, or breastfeeding. 3. Has active or chronic skin allergies. 4. Has a history of acute or chronic disease that might interfere with or increase the risk of study participation. 5. Had skin cancer treatment in preceding 12 months. 6. Has damaged skin on facial areas (e.g., sunburn, tattoo, or scar). 7. Had any medical procedure (e.g., laser resurfacing, chemical peel, or plastic surgery) on facial areas in preceding 12 months. 8. Had any cosmetic procedure (e.g., microdermabrasion) on facial areas within 8 weeks of the baseline visit. 9. Has any dermatological disorder that in the opinion of the Investigator may interfere with the accurate evaluation of the participant's facial appearance. 10. Received any investigational drug or procedure within 28 days of study day 1 or is scheduled to receive an investigational drug (other than the study products) or procedure during the study. 11. Currently using any medication that in the opinion of the Investigator may affect the evaluation of the study products or place the participant at undue risk. 12. Has a history of known or suspected intolerance to any of the ingredients of the study products (i.e., benzoyl peroxide). 13. Considered unable or unlikely to attend the necessary visits. 14. Has used non-steroidal anti-inflammatory drugs for the treatment of acne or for treatment durations longer than 7 days for any condition. 15. Uses oil-based sunscreens or sunscreens containing active ingredients that may have an effect on acne. 16. Has received treatment with estrogens (including oral, implanted, and topical contraceptives), androgens, or anti-androgenic agents for 12 weeks or less immediately prior to starting application of the study product. Participants who have been treated with estrogens, as described above, androgens, or anti-androgenic agents for more than 12 consecutive weeks prior to starting application of the study product are allowed to enroll as long as they do not expect to change dose, drug, or discontinue use during the study. 17. Has used topical antibiotics on the face or use of systemic antibiotics within the previous 2 weeks. 18. Has used topical anti-acne medications (e.g., BPO, azelaic acid, resorcinol, salicylates) within the previous 2 weeks. 19. Has used topical corticosteroids on the face or systemic corticosteroids within the previous 4 weeks. Use of inhaled, intra-articular or intra-lesional steroids other than for facial acne is acceptable. 20. Has used systemic retinoids within the previous 6 months or topical retinoids within the previous 6 weeks. 21. Uses abradants, facials, peels containing glycolic or other acids; masks, washes or soaps containing BPO, salicylic acid, or sulfacetamide sodium; non-mild facial cleansers, or moisturizers that contain retinol, salicylic acid or α- or β-hydroxy acids. 22. Uses medications known to exacerbate acne (e.g., mega-doses of vitamin D \[\>2000 IU/day\] and vitamin B12 \[\>1 mg/day\]; systemic steroids; androgens; haloperidol; halogens such as iodide and bromide; lithium; hydantoin; and phenobarbital). 23. Has had any facial procedure (e.g., blue light, chemical or laser peel, microdermabrasion) performed by any practitioner within 4 weeks before the study started or during the course of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Assess the Percentage Change in Acne Lesion Swelling (Height) of the Target Lesion for 3% Benzoyl Peroxide (BPO) Gel Test Product Relative to the Vehicle Gel After 4 Once-daily Applications. | Baseline to Day 4 | The Investigator assessed and score each target lesion's swelling (elevation), elevation scores were the actual dimensions, i.e. the value in millimeters at the lesion's highest points. Percent change in height of all three target lesions were calculated and averaged for each participant. The average lesion height at baseline was calculated for each participant. An analysis of covariance (ANCOVA) was performed with average percentage change in target lesion height as the response variable, treatment group (3% BPO or vehicle) as a main effect, and average baseline target lesion height as a covariate. A greater reduction in the percentage change in height of the target lesions indicated a better outcome measure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Assess the Percentage Change in Acne Lesion Swelling (Height) for the 3% Benzoyl Peroxide Gel Test Product and Positive Control Relative to the Vehicle Gel. | Baseline to 2 hours, 4 hours, Day 1, Day 2 and Day 4 | The Investigator assessed and score each target lesion's swelling (elevation), elevation scores were the actual dimensions, i.e. the value in millimeters at the lesion's highest points. Percent change in height of all three target lesions were calculated and averaged for each participant. The average lesion height at baseline was calculated for each participant |
| To Assess the Change in Acne Lesion Redness (Erythema) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel. | Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4 | The investigator assessed the erythema of the target lesion according to the following scale and tabulated the responses: 0=none, 1=minimal, 2=mild, 3=-moderate, 4=severe. |
| To Assess the Percentage Change in Acne Lesion Diameter (Size) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel. | Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4 | The Investigator assessed and score each target lesion's diameter (size). Diameter scores were the actual dimensions, i.e. the value in millimeters at the lesion's widest or highest points. |
| To Assess the Change in Facial Skin Clarity for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel | Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4 | The Skin clarity was measured using the following scale; 0 Very Clear; 1 Clear; 2 Dull; 3 Very Dull; 4 Unclear. The responses were then tabulated |
| To Assess the Change in Perceptions of the Overall Appearance of Their Skin for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel | Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4 | The participants were asked to rate the overall appearance of their facial skin as; 1= Very Dissatisfied; 2= Slightly Dissatisfied; 3= Neither Satisfied nor Dissatisfied; 4= Slightly Satisfied; 5= Very Satisfied. The responses were then tabulated. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited at a clinical site in USA
Pre-assignment details
A total of 90 participants were randomized across the three treatment groups.
Participants by arm
| Arm | Count |
|---|---|
| Test Product Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3. | 30 |
| Vehicle Gel The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3. | 30 |
| Positive Control A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3. | 30 |
| Total | 90 |
Baseline characteristics
| Characteristic | Test Product | Vehicle Gel | Positive Control | Total |
|---|---|---|---|---|
| Age, Continuous | 22.1 Years STANDARD_DEVIATION 9.9 | 20.3 Years STANDARD_DEVIATION 7.47 | 17.8 Years STANDARD_DEVIATION 6.22 | 20.1 Years STANDARD_DEVIATION 8.11 |
| Sex: Female, Male Female | 18 Participants 60 | 17 Participants 56.7 | 12 Participants 40 | 47 Participants |
| Sex: Female, Male Male | 12 Participants 40 | 13 Participants 43.3 | 18 Participants 60 | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 30 |
Outcome results
Primary
To Assess the Percentage Change in Acne Lesion Swelling (Height) of the Target Lesion for 3% Benzoyl Peroxide (BPO) Gel Test Product Relative to the Vehicle Gel After 4 Once-daily Applications.
The Investigator assessed and score each target lesion's swelling (elevation), elevation scores were the actual dimensions, i.e. the value in millimeters at the lesion's highest points. Percent change in height of all three target lesions were calculated and averaged for each participant. The average lesion height at baseline was calculated for each participant. An analysis of covariance (ANCOVA) was performed with average percentage change in target lesion height as the response variable, treatment group (3% BPO or vehicle) as a main effect, and average baseline target lesion height as a covariate. A greater reduction in the percentage change in height of the target lesions indicated a better outcome measure
Time frame: Baseline to Day 4
Population: The analysis population consists of the intent-to-treat (ITT) population. The ITT analysis set comprised of all participants who were randomized and received at least 1 application of study product and had baseline assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Product | To Assess the Percentage Change in Acne Lesion Swelling (Height) of the Target Lesion for 3% Benzoyl Peroxide (BPO) Gel Test Product Relative to the Vehicle Gel After 4 Once-daily Applications. | -57.42 Percentage change | Standard Error 6.229 |
| Vehicle Gel | To Assess the Percentage Change in Acne Lesion Swelling (Height) of the Target Lesion for 3% Benzoyl Peroxide (BPO) Gel Test Product Relative to the Vehicle Gel After 4 Once-daily Applications. | -47.89 Percentage change | Standard Error 6.237 |
| Positive Control | To Assess the Percentage Change in Acne Lesion Swelling (Height) of the Target Lesion for 3% Benzoyl Peroxide (BPO) Gel Test Product Relative to the Vehicle Gel After 4 Once-daily Applications. | -53.07 Percentage change | Standard Error 6.233 |
Comparison: The ANCOVA results for the primary endpoint with treatment group as a main effect and average baseline value as a covariate showed no statistically significant differences in the percentage change from baseline in swelling of the target lesions between the 3% BPO group and the vehicle control group at Day 4 for the ITT populationp-value: 0.283ANCOVA
Secondary
To Assess the Change in Acne Lesion Redness (Erythema) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel.
The investigator assessed the erythema of the target lesion according to the following scale and tabulated the responses: 0=none, 1=minimal, 2=mild, 3=-moderate, 4=severe.
Time frame: Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4
Population: The analysis population consists of the ITT population. The ITT analysis set comprised of all participants who were randomized and received at least 1 application of study product and had baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product | To Assess the Change in Acne Lesion Redness (Erythema) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel. | Change from baseline to hour 4 | -0.12 Units on a scale | Standard Deviation 0.283 |
| Test Product | To Assess the Change in Acne Lesion Redness (Erythema) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel. | Change from baseline to hour 2 | -0.04 Units on a scale | Standard Deviation 0.19 |
| Test Product | To Assess the Change in Acne Lesion Redness (Erythema) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel. | Change from baseline to day 1 | -0.62 Units on a scale | Standard Deviation 0.811 |
| Test Product | To Assess the Change in Acne Lesion Redness (Erythema) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel. | Change from baseline to day 4 | -1.83 Units on a scale | Standard Deviation 1.228 |
| Test Product | To Assess the Change in Acne Lesion Redness (Erythema) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel. | Change from baseline to day 2 | -1.26 Units on a scale | Standard Deviation 1.225 |
| Vehicle Gel | To Assess the Change in Acne Lesion Redness (Erythema) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel. | Change from baseline to day 4 | -1.39 Units on a scale | Standard Deviation 1.247 |
| Vehicle Gel | To Assess the Change in Acne Lesion Redness (Erythema) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel. | Change from baseline to hour 2 | -0.02 Units on a scale | Standard Deviation 0.122 |
| Vehicle Gel | To Assess the Change in Acne Lesion Redness (Erythema) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel. | Change from baseline to hour 4 | -0.06 Units on a scale | Standard Deviation 0.304 |
| Vehicle Gel | To Assess the Change in Acne Lesion Redness (Erythema) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel. | Change from baseline to day 1 | -0.56 Units on a scale | Standard Deviation 0.639 |
| Vehicle Gel | To Assess the Change in Acne Lesion Redness (Erythema) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel. | Change from baseline to day 2 | -1.02 Units on a scale | Standard Deviation 0.967 |
| Positive Control | To Assess the Change in Acne Lesion Redness (Erythema) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel. | Change from baseline to day 1 | -0.73 Units on a scale | Standard Deviation 0.851 |
| Positive Control | To Assess the Change in Acne Lesion Redness (Erythema) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel. | Change from baseline to hour 2 | -0.03 Units on a scale | Standard Deviation 0.221 |
| Positive Control | To Assess the Change in Acne Lesion Redness (Erythema) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel. | Change from baseline to day 4 | -1.84 Units on a scale | Standard Deviation 1.303 |
| Positive Control | To Assess the Change in Acne Lesion Redness (Erythema) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel. | Change from baseline to hour 4 | -0.10 Units on a scale | Standard Deviation 0.279 |
| Positive Control | To Assess the Change in Acne Lesion Redness (Erythema) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel. | Change from baseline to day 2 | -1.36 Units on a scale | Standard Deviation 1.168 |
Secondary
To Assess the Change in Facial Skin Clarity for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel
The Skin clarity was measured using the following scale; 0 Very Clear; 1 Clear; 2 Dull; 3 Very Dull; 4 Unclear. The responses were then tabulated
Time frame: Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4
Population: The analysis population consists of the ITT population. The ITT analysis set comprised of all participants who were randomized and received at least 1 application of study product and had baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product | To Assess the Change in Facial Skin Clarity for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel | Baseline to hour 4 | 0.0 Units on a scale | Standard Deviation 0 |
| Test Product | To Assess the Change in Facial Skin Clarity for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel | Baseline to hour 2 | 0.0 Units on a scale | Standard Deviation 0 |
| Test Product | To Assess the Change in Facial Skin Clarity for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel | Baseline to day 1 | -0.2 Units on a scale | Standard Deviation 0.43 |
| Test Product | To Assess the Change in Facial Skin Clarity for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel | Baseline to day 4 | -1.2 Units on a scale | Standard Deviation 0.9 |
| Test Product | To Assess the Change in Facial Skin Clarity for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel | Baseline to day 2 | -0.8 Units on a scale | Standard Deviation 0.81 |
| Vehicle Gel | To Assess the Change in Facial Skin Clarity for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel | Baseline to day 4 | -0.7 Units on a scale | Standard Deviation 0.79 |
| Vehicle Gel | To Assess the Change in Facial Skin Clarity for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel | Baseline to hour 2 | 0.0 Units on a scale | Standard Deviation 0 |
| Vehicle Gel | To Assess the Change in Facial Skin Clarity for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel | Baseline to hour 4 | 0.0 Units on a scale | Standard Deviation 0 |
| Vehicle Gel | To Assess the Change in Facial Skin Clarity for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel | Baseline to day 1 | -0.2 Units on a scale | Standard Deviation 0.38 |
| Vehicle Gel | To Assess the Change in Facial Skin Clarity for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel | Baseline to day 2 | -0.5 Units on a scale | Standard Deviation 0.51 |
| Positive Control | To Assess the Change in Facial Skin Clarity for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel | Baseline to day 1 | -0.3 Units on a scale | Standard Deviation 0.48 |
| Positive Control | To Assess the Change in Facial Skin Clarity for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel | Baseline to hour 2 | 0.0 Units on a scale | Standard Deviation 0 |
| Positive Control | To Assess the Change in Facial Skin Clarity for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel | Baseline to day 4 | -1.0 Units on a scale | Standard Deviation 0.98 |
| Positive Control | To Assess the Change in Facial Skin Clarity for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel | Baseline to hour 4 | 0.0 Units on a scale | Standard Deviation 0 |
| Positive Control | To Assess the Change in Facial Skin Clarity for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel | Baseline to day 2 | -0.7 Units on a scale | Standard Deviation 0.84 |
Secondary
To Assess the Change in Perceptions of the Overall Appearance of Their Skin for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel
The participants were asked to rate the overall appearance of their facial skin as; 1= Very Dissatisfied; 2= Slightly Dissatisfied; 3= Neither Satisfied nor Dissatisfied; 4= Slightly Satisfied; 5= Very Satisfied. The responses were then tabulated.
Time frame: Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4
Population: The analysis population consists of the ITT population. The ITT analysis set comprised of all participants who were randomized and received at least 1 application of study product and had baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product | To Assess the Change in Perceptions of the Overall Appearance of Their Skin for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel | Change from baseline to day 4 | 0.9 Units on a scale | Standard Deviation 1.03 |
| Test Product | To Assess the Change in Perceptions of the Overall Appearance of Their Skin for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel | Change from baseline to day 1 | 0.3 Units on a scale | Standard Deviation 0.92 |
| Test Product | To Assess the Change in Perceptions of the Overall Appearance of Their Skin for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel | Change from baseline to hour 4 | 0.4 Units on a scale | Standard Deviation 0.93 |
| Test Product | To Assess the Change in Perceptions of the Overall Appearance of Their Skin for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel | Change from baseline to hour 2 | 0.3 Units on a scale | Standard Deviation 0.84 |
| Test Product | To Assess the Change in Perceptions of the Overall Appearance of Their Skin for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel | Change from baseline to day 2 | 0.5 Units on a scale | Standard Deviation 1.14 |
| Vehicle Gel | To Assess the Change in Perceptions of the Overall Appearance of Their Skin for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel | Change from baseline to day 2 | 0.6 Units on a scale | Standard Deviation 1.03 |
| Vehicle Gel | To Assess the Change in Perceptions of the Overall Appearance of Their Skin for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel | Change from baseline to day 1 | 0.3 Units on a scale | Standard Deviation 1.03 |
| Vehicle Gel | To Assess the Change in Perceptions of the Overall Appearance of Their Skin for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel | Change from baseline to day 4 | 0.8 Units on a scale | Standard Deviation 1.3 |
| Vehicle Gel | To Assess the Change in Perceptions of the Overall Appearance of Their Skin for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel | Change from baseline to hour 2 | 0.1 Units on a scale | Standard Deviation 0.82 |
| Vehicle Gel | To Assess the Change in Perceptions of the Overall Appearance of Their Skin for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel | Change from baseline to hour 4 | 0.3 Units on a scale | Standard Deviation 0.99 |
| Positive Control | To Assess the Change in Perceptions of the Overall Appearance of Their Skin for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel | Change from baseline to day 4 | 0.8 Units on a scale | Standard Deviation 1.32 |
| Positive Control | To Assess the Change in Perceptions of the Overall Appearance of Their Skin for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel | Change from baseline to hour 4 | 0.4 Units on a scale | Standard Deviation 1.07 |
| Positive Control | To Assess the Change in Perceptions of the Overall Appearance of Their Skin for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel | Change from baseline to day 1 | 0.4 Units on a scale | Standard Deviation 1.13 |
| Positive Control | To Assess the Change in Perceptions of the Overall Appearance of Their Skin for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel | Change from baseline to day 2 | 0.7 Units on a scale | Standard Deviation 1.24 |
| Positive Control | To Assess the Change in Perceptions of the Overall Appearance of Their Skin for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel | Change from baseline to hour 2 | 0.3 Units on a scale | Standard Deviation 0.71 |
Secondary
To Assess the Percentage Change in Acne Lesion Diameter (Size) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel.
The Investigator assessed and score each target lesion's diameter (size). Diameter scores were the actual dimensions, i.e. the value in millimeters at the lesion's widest or highest points.
Time frame: Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4
Population: The analysis population consists of the ITT population. The ITT analysis set comprised of all participants who were randomized and received at least 1 application of study product and had baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product | To Assess the Percentage Change in Acne Lesion Diameter (Size) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel. | From baseline to day 1 | -12.46 Percentage change | Standard Deviation 27.993 |
| Test Product | To Assess the Percentage Change in Acne Lesion Diameter (Size) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel. | From baseline to hour 4 | -0.74 Percentage change | Standard Deviation 9.397 |
| Test Product | To Assess the Percentage Change in Acne Lesion Diameter (Size) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel. | From baseline to hour 2 | -0.46 Percentage change | Standard Deviation 10.92 |
| Test Product | To Assess the Percentage Change in Acne Lesion Diameter (Size) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel. | From baseline to day 2 | -30.98 Percentage change | Standard Deviation 38.935 |
| Test Product | To Assess the Percentage Change in Acne Lesion Diameter (Size) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel. | From baseline to day 4 | -52.56 Percentage change | Standard Deviation 39.058 |
| Vehicle Gel | To Assess the Percentage Change in Acne Lesion Diameter (Size) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel. | From baseline to hour 4 | -0.22 Percentage change | Standard Deviation 10.666 |
| Vehicle Gel | To Assess the Percentage Change in Acne Lesion Diameter (Size) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel. | From baseline to day 4 | -38.78 Percentage change | Standard Deviation 44.7 |
| Vehicle Gel | To Assess the Percentage Change in Acne Lesion Diameter (Size) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel. | From baseline to hour 2 | -1.33 Percentage change | Standard Deviation 7.274 |
| Vehicle Gel | To Assess the Percentage Change in Acne Lesion Diameter (Size) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel. | From baseline to day 1 | -12.83 Percentage change | Standard Deviation 20.836 |
| Vehicle Gel | To Assess the Percentage Change in Acne Lesion Diameter (Size) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel. | From baseline to day 2 | -29.81 Percentage change | Standard Deviation 36.983 |
| Positive Control | To Assess the Percentage Change in Acne Lesion Diameter (Size) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel. | From baseline to day 2 | -37.83 Percentage change | Standard Deviation 32.315 |
| Positive Control | To Assess the Percentage Change in Acne Lesion Diameter (Size) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel. | From baseline to day 1 | -11.93 Percentage change | Standard Deviation 22.049 |
| Positive Control | To Assess the Percentage Change in Acne Lesion Diameter (Size) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel. | From baseline to day 4 | -44.78 Percentage change | Standard Deviation 35.933 |
| Positive Control | To Assess the Percentage Change in Acne Lesion Diameter (Size) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel. | From baseline to hour 4 | -0.63 Percentage change | Standard Deviation 9.244 |
| Positive Control | To Assess the Percentage Change in Acne Lesion Diameter (Size) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel. | From baseline to hour 2 | -0.33 Percentage change | Standard Deviation 7.112 |
Secondary
To Assess the Percentage Change in Acne Lesion Swelling (Height) for the 3% Benzoyl Peroxide Gel Test Product and Positive Control Relative to the Vehicle Gel.
The Investigator assessed and score each target lesion's swelling (elevation), elevation scores were the actual dimensions, i.e. the value in millimeters at the lesion's highest points. Percent change in height of all three target lesions were calculated and averaged for each participant. The average lesion height at baseline was calculated for each participant
Time frame: Baseline to 2 hours, 4 hours, Day 1, Day 2 and Day 4
Population: The analysis population consists of the ITT population. The ITT analysis set comprised of all participants who were randomized and received at least 1 application of study product and had baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product | To Assess the Percentage Change in Acne Lesion Swelling (Height) for the 3% Benzoyl Peroxide Gel Test Product and Positive Control Relative to the Vehicle Gel. | From baseline to day 1 | -21.42 Percentage change | Standard Deviation 25.578 |
| Test Product | To Assess the Percentage Change in Acne Lesion Swelling (Height) for the 3% Benzoyl Peroxide Gel Test Product and Positive Control Relative to the Vehicle Gel. | From baseline to hour 2 | -3.24 Percentage change | Standard Deviation 8.726 |
| Test Product | To Assess the Percentage Change in Acne Lesion Swelling (Height) for the 3% Benzoyl Peroxide Gel Test Product and Positive Control Relative to the Vehicle Gel. | From baseline to day 4 | -57.22 Percentage change | Standard Deviation 36.372 |
| Test Product | To Assess the Percentage Change in Acne Lesion Swelling (Height) for the 3% Benzoyl Peroxide Gel Test Product and Positive Control Relative to the Vehicle Gel. | From baseline to hour 4 | -6.02 Percentage change | Standard Deviation 9.172 |
| Test Product | To Assess the Percentage Change in Acne Lesion Swelling (Height) for the 3% Benzoyl Peroxide Gel Test Product and Positive Control Relative to the Vehicle Gel. | From baseline to day 2 | -40.30 Percentage change | Standard Deviation 34.011 |
| Vehicle Gel | To Assess the Percentage Change in Acne Lesion Swelling (Height) for the 3% Benzoyl Peroxide Gel Test Product and Positive Control Relative to the Vehicle Gel. | From baseline to hour 4 | -7.01 Percentage change | Standard Deviation 11.525 |
| Vehicle Gel | To Assess the Percentage Change in Acne Lesion Swelling (Height) for the 3% Benzoyl Peroxide Gel Test Product and Positive Control Relative to the Vehicle Gel. | From baseline to day 1 | -22.07 Percentage change | Standard Deviation 19.688 |
| Vehicle Gel | To Assess the Percentage Change in Acne Lesion Swelling (Height) for the 3% Benzoyl Peroxide Gel Test Product and Positive Control Relative to the Vehicle Gel. | From baseline to day 2 | -37.03 Percentage change | Standard Deviation 28.968 |
| Vehicle Gel | To Assess the Percentage Change in Acne Lesion Swelling (Height) for the 3% Benzoyl Peroxide Gel Test Product and Positive Control Relative to the Vehicle Gel. | From baseline to day 4 | -48.60 Percentage change | Standard Deviation 34.585 |
| Vehicle Gel | To Assess the Percentage Change in Acne Lesion Swelling (Height) for the 3% Benzoyl Peroxide Gel Test Product and Positive Control Relative to the Vehicle Gel. | From baseline to hour 2 | -4.65 Percentage change | Standard Deviation 10.558 |
| Positive Control | To Assess the Percentage Change in Acne Lesion Swelling (Height) for the 3% Benzoyl Peroxide Gel Test Product and Positive Control Relative to the Vehicle Gel. | From baseline to day 2 | -42.94 Percentage change | Standard Deviation 31.121 |
| Positive Control | To Assess the Percentage Change in Acne Lesion Swelling (Height) for the 3% Benzoyl Peroxide Gel Test Product and Positive Control Relative to the Vehicle Gel. | From baseline to hour 4 | -5.94 Percentage change | Standard Deviation 11.774 |
| Positive Control | To Assess the Percentage Change in Acne Lesion Swelling (Height) for the 3% Benzoyl Peroxide Gel Test Product and Positive Control Relative to the Vehicle Gel. | From baseline to hour 2 | -4.57 Percentage change | Standard Deviation 10.754 |
| Positive Control | To Assess the Percentage Change in Acne Lesion Swelling (Height) for the 3% Benzoyl Peroxide Gel Test Product and Positive Control Relative to the Vehicle Gel. | From baseline to day 1 | -20.22 Percentage change | Standard Deviation 25.711 |
| Positive Control | To Assess the Percentage Change in Acne Lesion Swelling (Height) for the 3% Benzoyl Peroxide Gel Test Product and Positive Control Relative to the Vehicle Gel. | From baseline to day 4 | -52.57 Percentage change | Standard Deviation 33.58 |