Acne Vulgaris
Conditions
Keywords
Acne
Brief summary
This study will compare two different acne treatment regimens for the treatment of acne. Half of participants will receive a cleanser and a light therapy mask, while half of the participants will receive a cleanser, a light therapy topical gel-cream, and a light therapy mask.
Detailed description
Acne vulgaris is a common chronic skin disease involving blockage and/or inflammation of the hair follicles and their accompany sebaceous glands. Research has shown the benefits of red and blue light therapy in the treatment of mild to moderate acne, with red and blue light shown to target acne-causing bacteria and have an effect on inflammation reduction. Light-based therapies have been used successfully to treat dermatological conditions since the early 1900s, with various parts of the electromagnetic spectrum (i.e. ultraviolet \[UV\], visible, near-infrared, etc.) demonstrating different benefits. Light-emitting diodes (LEDs) offer delivery of light to the skin in a gentler manner as compared to light delivered by lasers, primarily due to the lower energy output. It has been reported that LEDs do not deliver enough power to damage tissues and do not have the same risk of accidental eye damage that lasers do. Visible-LED light therapy has been deemed a non-significant risk by the U.S. Food and Drug Administration (FDA) and has been approved for use in humans. It is well established in the literature that visible light penetration into the epidermal and dermal layers of human skin is primarily governed by absorption and scattering events, with the latter being the more impactful of the two. Visible light penetration into human skin can be increased by reducing scattering. This can be accomplished by temporary hydrogen bonding disruption, which leads to the reversible rearrangement of epidermal and dermal structures that cause scattering. Glycerol (i.e. glycerin) is hypothesized to generate the level of hydrogen bonding disruption described above, and therefore will be investigated in the present study. This study will look to evaluate and then compare the acne clearing efficacy and tolerance of two different acne treatment regimens - a cleanser used with a currently marketed red and blue light acne light therapy mask alone vs. the cleanser used with the same mask in conjunction with a light therapy topical gel-cream - to determine the efficacy of these treatments and then to assess if the efficacy of the light therapy mask used with the topical gel-cream treatment is non-inferior to the mask alone in the reduction of lesions in mild to moderate acne. If non-inferiority is demonstrated, the mask with topical gel-cream treatment will be further assessed for its superiority to the mask alone.
Interventions
DEVICECleanser, Acne Mask
A facial cleanser will be used twice daily (morning and evening). The light therapy mask will be used for 10 minutes in the evening after washing/drying the face.
DEVICECleanser, Gel-Cream, Acne Mask
A facial cleanser will be used twice daily (morning and evening). In the evening after cleansing, the gel-cream will be applied full face and allowed to dry before the light therapy mask is used for 10 minutes.
Sponsors
Johnson & Johnson Consumer Inc. (J&JCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Evaluator-blind
Eligibility
Sex/Gender
ALL
Age
12 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Has mild to moderate facial acne * Has 10-100 blackheads/whiteheads, 10-50 pimples, no cysts, and up to 2 large, hard, painful bumps (nodules) * Able to read, write, speak, and understand English * In general good health * Must agree to practice a medically acceptable form of birth control. * Intends to complete the study and willing to follow all study instructions.
Exclusion criteria
* Very sensitive skin or allergies/sensitivity to skincare products or the test product ingredients. * Has a light or photosensitivity disorder or another medical condition that could increase risk to the subject or confuse the study results * Is using medication that makes skin more sensitive to light * Has severe acne or a pre-existing facial skin condition other than mild to moderate acne * has an immune deficiency disorder * has been using a product or medication that the stuff investigator determines will increase health risk to the subject or confuse the study results * Females that are pregnant, nursing, or planning to become pregnant * Males with a female partner who is pregnant or planning to become pregnant * Has excessive facial hair * Is participating in another study within past 4 weeks * Is related to the Sponsor, Investigator, or Study Site
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Face Total Lesion Count - Percent Change - Baseline to Week 12 | Baseline and Week 12 | Percent change from baseline in global face total lesion count at Week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Global Acne Assessment - Week 2 | 2 weeks | Investigator Global Acne Assessment using Modified Cooke's Scale - Week 2. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed. |
| Investigator Global Acne Assessment - Week 4 | 4 weeks | Investigator Global Acne Assessment using Modified Cooke's Scale - Week 4. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed. |
| Investigator Global Acne Assessment - Week 8 | 8 weeks | Investigator Global Acne Assessment using Modified Cooke's Scale - Week 8. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed. |
| Global Face Non-Inflammatory Lesion Count - Week 12 | 12 weeks | Sum of open comedones and closed comedones |
| Global Face Total Lesion Count - Week 2 | 2 weeks | Sum of inflammatory and non-inflammatory lesions |
| Global Face Total Lesion Count - Week 4 | 4 weeks | Sum of inflammatory and non-inflammatory lesions |
| Global Face Total Lesion Count - Week 8 | 8 weeks | Sum of inflammatory and non-inflammatory lesions |
| Global Face Total Lesion Count - Week 12 | 12 weeks | Sum of inflammatory and non-inflammatory lesions |
| Global Face Total Lesion Count - Percent Change - Baseline to Week 2 | Baseline and Week 2 | Percent change from baseline in global face total lesion count at Week 2 |
| Global Face Total Lesion Count - Percent Change - Baseline to Week 4 | Baseline and Week 4 | Percent change from baseline in global face total lesion count at Week 4 |
| Global Face Total Lesion Count - Percent Change - Baseline to Week 8 | Baseline and Week 8 | Percent change from baseline in global face total lesion count at Week 8 |
| Global Face Total Lesion Count - Percent Change From Baseline to the Mean of All Visits | Baseline to Week 2, Week 4, Week 8, and Week 12 | Global face total lesion counts are averaged across all applicable post-baseline visits (Week 2, Week 4, Week 8, and Week 12). Percent change from baseline to the mean is then calculated. |
| Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 2 and Week 4 | Baseline to Week 2 and Week 4 | Global face total lesion counts are averaged across Week 2 and Week 4. Percent change from baseline to the mean is then calculated. |
| Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 4 and Week 8 | Baseline to Week 4 and Week 8 | Global face total lesion counts are averaged across Week 4 and Week 8. Percent change from baseline to the mean is then calculated. |
| Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 8 and Week 12 | Baseline to Week 8 and Week 12 | Global face total lesion counts are averaged across Week 8 and Week 12. Percent change from baseline to the mean is then calculated. |
| Global Face Open Comedones Count - Week 2 | 2 weeks | Open comedones count on global face - Week 2 |
| Global Face Open Comedones Count - Week 4 | 4 weeks | Open comedones count on global face - Week 4 |
| Global Face Open Comedones Count - Week 8 | 8 weeks | Open comedones count on global face - Week 8 |
| Global Face Open Comedones Count - Week 12 | 12 weeks | Open comedones count on global face - Week 12 |
| Global Face Closed Comedones Count - Week 2 | 2 weeks | Closed comedones count on global face - Week 2 |
| Global Face Closed Comedones Count - Week 4 | 4 weeks | Closed comedones count on global face - Week 4 |
| Global Face Closed Comedones Count - Week 8 | 8 weeks | Closed comedones count on global face - Week 8 |
| Global Face Closed Comedones Count - Week 12 | 12 weeks | Closed comedones count on global face - Week 12 |
| Global Face Inflammatory Lesion Count - Week 2 | 2 weeks | Papules and pustules counted together |
| Global Face Inflammatory Lesion Count - Week 4 | 4 weeks | Papules and pustules counted together |
| Global Face Inflammatory Lesion Count - Week 8 | 8 weeks | Papules and pustules counted together |
| Global Face Inflammatory Lesion Count - Week 12 | 12 weeks | Papules and pustules counted together |
| Global Face Non-Inflammatory Lesion Count - Week 2 | 2 weeks | Sum of open comedones and closed comedones |
| Global Face Non-Inflammatory Lesion Count - Week 4 | 4 weeks | Sum of open comedones and closed comedones |
| Global Face Non-Inflammatory Lesion Count - Week 8 | 8 weeks | Sum of open comedones and closed comedones |
| Investigator Global Acne Assessment - Week 12 | 12 weeks | Investigator Global Acne Assessment using Modified Cooke's Scale - Week 12. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed. |
| Overall Redness of Inflammatory Lesions - Week 1 | 1 week | Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness |
| Overall Redness of Inflammatory Lesions - Week 2 | 2 weeks | Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness |
| Overall Redness of Inflammatory Lesions - Week 4 | 4 weeks | Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness |
| Overall Redness of Inflammatory Lesions - Week 8 | 8 weeks | Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness |
| Overall Redness of Inflammatory Lesions - Week 12 | 12 weeks | Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness |
| Investigator Global Acne Assessment - Week 1 | 1 week | Investigator Global Acne Assessment using Modified Cooke's Scale - Week 1. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed. |
| Overall Size of Inflammatory Lesions - Week 2 | 2 weeks | Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large |
| Overall Size of Inflammatory Lesions - Week 4 | 4 weeks | Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large |
| Overall Size of Inflammatory Lesions - Week 8 | 8 weeks | Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large. |
| Overall Size of Inflammatory Lesions - Week 12 | 12 weeks | Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large |
| Overall Size of Inflammatory Lesions - Week 1 | 1 week | Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gel-Cream + Acne Mask Cleanser, Gel-Cream, Acne Mask | 65 |
| Acne Mask Cleanser, Acne Mask | 61 |
| Total | 126 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Non-Compliance with Study Treatment | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 6 | 3 |
Baseline characteristics
| Characteristic | Acne Mask | Total | Gel-Cream + Acne Mask |
|---|---|---|---|
| Age, Continuous | 20.0 Years STANDARD_DEVIATION 7.65 | 19.4 Years STANDARD_DEVIATION 6.86 | 18.8 Years STANDARD_DEVIATION 6.03 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 23 Participants | 48 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants | 78 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Skin Type I | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Skin Type II | 28 Participants | 52 Participants | 24 Participants |
| Fitzpatrick Skin Type III | 14 Participants | 32 Participants | 18 Participants |
| Fitzpatrick Skin Type IV | 10 Participants | 22 Participants | 12 Participants |
| Fitzpatrick Skin Type V | 6 Participants | 16 Participants | 10 Participants |
| Fitzpatrick Skin Type VI | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 22 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) White | 47 Participants | 94 Participants | 47 Participants |
| Sex: Female, Male Female | 32 Participants | 70 Participants | 38 Participants |
| Sex: Female, Male Male | 29 Participants | 56 Participants | 27 Participants |
| Skin Sensitivity All of the Time | 2 Participants | 2 Participants | 0 Participants |
| Skin Sensitivity Most of the Time | 1 Participants | 7 Participants | 6 Participants |
| Skin Sensitivity None of the Time | 40 Participants | 78 Participants | 38 Participants |
| Skin Sensitivity Some of the Time | 18 Participants | 39 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 65 | 0 / 61 |
| other Total, other adverse events | 0 / 65 | 0 / 61 |
| serious Total, serious adverse events | 0 / 65 | 0 / 61 |
Outcome results
Primary
Global Face Total Lesion Count - Percent Change - Baseline to Week 12
Percent change from baseline in global face total lesion count at Week 12
Time frame: Baseline and Week 12
Population: Intent-to-treat population was used, including all subjects with data for this time point. Missing values were imputed by carrying forward the last observed post-baseline score. There was no post-baseline data to carry forward for three subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Global Face Total Lesion Count - Percent Change - Baseline to Week 12 | -42.64 Percent Change in Lesions | Standard Deviation 31.817 |
| Acne Mask | Global Face Total Lesion Count - Percent Change - Baseline to Week 12 | -47.80 Percent Change in Lesions | Standard Deviation 30.209 |
Comparison: Non-inferiority test performed after significance vs. baseline confirmed for each cell. The null hypothesis for the non-inferiority test was H0: A-B≥15%, where A and B are the mean percent change at Week 12 of global face total acne lesion count of the Gel-Cream + Acne Mask cell and Acne Mask cell, respectively.95% CI: [-7.04, 13.42]
Comparison: Superiority test performed after non-inferiority confirmed as described above. The null hypothesis for the superiority test was H0: A-B = 0, where A and B are the mean percent change at Week 12 of global face total acne lesion count of the Acne Mask and the Gel-Cream + Acne Mask cell, respectively.p-value: 0.53895% CI: [-7.04, 13.42]ANCOVA
Secondary
Global Face Closed Comedones Count - Week 12
Closed comedones count on global face - Week 12
Time frame: 12 weeks
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Global Face Closed Comedones Count - Week 12 | 11.9 Closed Comedones | Standard Deviation 10.01 |
| Acne Mask | Global Face Closed Comedones Count - Week 12 | 10.2 Closed Comedones | Standard Deviation 9 |
Secondary
Global Face Closed Comedones Count - Week 2
Closed comedones count on global face - Week 2
Time frame: 2 weeks
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Global Face Closed Comedones Count - Week 2 | 14.7 Closed Comedones | Standard Deviation 10.66 |
| Acne Mask | Global Face Closed Comedones Count - Week 2 | 12.7 Closed Comedones | Standard Deviation 9.41 |
Secondary
Global Face Closed Comedones Count - Week 4
Closed comedones count on global face - Week 4
Time frame: 4 weeks
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Global Face Closed Comedones Count - Week 4 | 14.1 Closed Comedones | Standard Deviation 11.69 |
| Acne Mask | Global Face Closed Comedones Count - Week 4 | 10.9 Closed Comedones | Standard Deviation 7.01 |
Secondary
Global Face Closed Comedones Count - Week 8
Closed comedones count on global face - Week 8
Time frame: 8 weeks
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Global Face Closed Comedones Count - Week 8 | 12.7 Closed Comedones | Standard Deviation 10.38 |
| Acne Mask | Global Face Closed Comedones Count - Week 8 | 10.3 Closed Comedones | Standard Deviation 7.05 |
Secondary
Global Face Inflammatory Lesion Count - Week 12
Papules and pustules counted together
Time frame: 12 weeks
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Global Face Inflammatory Lesion Count - Week 12 | 9.7 Inflammatory Lesions | Standard Deviation 7.19 |
| Acne Mask | Global Face Inflammatory Lesion Count - Week 12 | 7.7 Inflammatory Lesions | Standard Deviation 6.44 |
Secondary
Global Face Inflammatory Lesion Count - Week 2
Papules and pustules counted together
Time frame: 2 weeks
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Global Face Inflammatory Lesion Count - Week 2 | 12.1 Inflammatory Lesions | Standard Deviation 8.23 |
| Acne Mask | Global Face Inflammatory Lesion Count - Week 2 | 10.3 Inflammatory Lesions | Standard Deviation 5.24 |
Secondary
Global Face Inflammatory Lesion Count - Week 4
Papules and pustules counted together
Time frame: 4 weeks
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Global Face Inflammatory Lesion Count - Week 4 | 10.8 Inflammatory Lesions | Standard Deviation 7.56 |
| Acne Mask | Global Face Inflammatory Lesion Count - Week 4 | 9.1 Inflammatory Lesions | Standard Deviation 6.15 |
Secondary
Global Face Inflammatory Lesion Count - Week 8
Papules and pustules counted together
Time frame: 8 weeks
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Global Face Inflammatory Lesion Count - Week 8 | 9.9 Inflammatory Lesions | Standard Deviation 6.85 |
| Acne Mask | Global Face Inflammatory Lesion Count - Week 8 | 7.8 Inflammatory Lesions | Standard Deviation 5.07 |
Secondary
Global Face Non-Inflammatory Lesion Count - Week 12
Sum of open comedones and closed comedones
Time frame: 12 weeks
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Global Face Non-Inflammatory Lesion Count - Week 12 | 15.6 Non-inflammatory Lesions | Standard Deviation 12.92 |
| Acne Mask | Global Face Non-Inflammatory Lesion Count - Week 12 | 14.0 Non-inflammatory Lesions | Standard Deviation 13.39 |
Secondary
Global Face Non-Inflammatory Lesion Count - Week 2
Sum of open comedones and closed comedones
Time frame: 2 weeks
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Global Face Non-Inflammatory Lesion Count - Week 2 | 22.7 Non-inflammatory Lesions | Standard Deviation 15.94 |
| Acne Mask | Global Face Non-Inflammatory Lesion Count - Week 2 | 18.3 Non-inflammatory Lesions | Standard Deviation 11.74 |
Secondary
Global Face Non-Inflammatory Lesion Count - Week 4
Sum of open comedones and closed comedones
Time frame: 4 weeks
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Global Face Non-Inflammatory Lesion Count - Week 4 | 22.0 Non-inflammatory lesions | Standard Deviation 16.39 |
| Acne Mask | Global Face Non-Inflammatory Lesion Count - Week 4 | 16.2 Non-inflammatory lesions | Standard Deviation 10.51 |
Secondary
Global Face Non-Inflammatory Lesion Count - Week 8
Sum of open comedones and closed comedones
Time frame: 8 weeks
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Global Face Non-Inflammatory Lesion Count - Week 8 | 17.8 Non-inflammatory Lesions | Standard Deviation 13.92 |
| Acne Mask | Global Face Non-Inflammatory Lesion Count - Week 8 | 14.8 Non-inflammatory Lesions | Standard Deviation 10.68 |
Secondary
Global Face Open Comedones Count - Week 12
Open comedones count on global face - Week 12
Time frame: 12 weeks
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Global Face Open Comedones Count - Week 12 | 3.6 Open Comedones | Standard Deviation 5.2 |
| Acne Mask | Global Face Open Comedones Count - Week 12 | 3.7 Open Comedones | Standard Deviation 6.31 |
Secondary
Global Face Open Comedones Count - Week 2
Open comedones count on global face - Week 2
Time frame: 2 weeks
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Global Face Open Comedones Count - Week 2 | 8.1 Open Comedones | Standard Deviation 10.68 |
| Acne Mask | Global Face Open Comedones Count - Week 2 | 5.6 Open Comedones | Standard Deviation 6.41 |
Secondary
Global Face Open Comedones Count - Week 4
Open comedones count on global face - Week 4
Time frame: 4 weeks
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Global Face Open Comedones Count - Week 4 | 7.9 Open Comedones | Standard Deviation 10.37 |
| Acne Mask | Global Face Open Comedones Count - Week 4 | 5.3 Open Comedones | Standard Deviation 6.27 |
Secondary
Global Face Open Comedones Count - Week 8
Open comedones count on global face - Week 8
Time frame: 8 weeks
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Global Face Open Comedones Count - Week 8 | 5.1 Open Comedones | Standard Deviation 7.83 |
| Acne Mask | Global Face Open Comedones Count - Week 8 | 4.5 Open Comedones | Standard Deviation 6.03 |
Secondary
Global Face Total Lesion Count - Percent Change - Baseline to Week 2
Percent change from baseline in global face total lesion count at Week 2
Time frame: Baseline and Week 2
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Global Face Total Lesion Count - Percent Change - Baseline to Week 2 | -24.16 Percent Change in Lesions | Standard Deviation 25.646 |
| Acne Mask | Global Face Total Lesion Count - Percent Change - Baseline to Week 2 | -27.97 Percent Change in Lesions | Standard Deviation 21.33 |
Secondary
Global Face Total Lesion Count - Percent Change - Baseline to Week 4
Percent change from baseline in global face total lesion count at Week 4
Time frame: Baseline and Week 4
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Global Face Total Lesion Count - Percent Change - Baseline to Week 4 | -29.78 Percent Change in Lesions | Standard Deviation 27.388 |
| Acne Mask | Global Face Total Lesion Count - Percent Change - Baseline to Week 4 | -38.25 Percent Change in Lesions | Standard Deviation 22.729 |
Secondary
Global Face Total Lesion Count - Percent Change - Baseline to Week 8
Percent change from baseline in global face total lesion count at Week 8
Time frame: Baseline and Week 8
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Global Face Total Lesion Count - Percent Change - Baseline to Week 8 | -39.81 Percent Change in Lesions | Standard Deviation 26.192 |
| Acne Mask | Global Face Total Lesion Count - Percent Change - Baseline to Week 8 | -45.86 Percent Change in Lesions | Standard Deviation 23.369 |
Secondary
Global Face Total Lesion Count - Percent Change From Baseline to the Mean of All Visits
Global face total lesion counts are averaged across all applicable post-baseline visits (Week 2, Week 4, Week 8, and Week 12). Percent change from baseline to the mean is then calculated.
Time frame: Baseline to Week 2, Week 4, Week 8, and Week 12
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Global Face Total Lesion Count - Percent Change From Baseline to the Mean of All Visits | -33.68 Percent Change in Lesions | Standard Deviation 24.212 |
| Acne Mask | Global Face Total Lesion Count - Percent Change From Baseline to the Mean of All Visits | -39.79 Percent Change in Lesions | Standard Deviation 20.754 |
Secondary
Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 2 and Week 4
Global face total lesion counts are averaged across Week 2 and Week 4. Percent change from baseline to the mean is then calculated.
Time frame: Baseline to Week 2 and Week 4
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 2 and Week 4 | -26.95 Percent Change in Lesions | Standard Deviation 24.419 |
| Acne Mask | Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 2 and Week 4 | -33.01 Percent Change in Lesions | Standard Deviation 19.648 |
Secondary
Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 4 and Week 8
Global face total lesion counts are averaged across Week 4 and Week 8. Percent change from baseline to the mean is then calculated.
Time frame: Baseline to Week 4 and Week 8
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 4 and Week 8 | -34.34 Percent Change in Lesions | Standard Deviation 25.438 |
| Acne Mask | Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 4 and Week 8 | -42.09 Percent Change in Lesions | Standard Deviation 21.082 |
Secondary
Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 8 and Week 12
Global face total lesion counts are averaged across Week 8 and Week 12. Percent change from baseline to the mean is then calculated.
Time frame: Baseline to Week 8 and Week 12
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 8 and Week 12 | -41.73 Percent Change in Lesions | Standard Deviation 27.472 |
| Acne Mask | Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 8 and Week 12 | -47.25 Percent Change in Lesions | Standard Deviation 46.201 |
Secondary
Global Face Total Lesion Count - Week 12
Sum of inflammatory and non-inflammatory lesions
Time frame: 12 weeks
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Global Face Total Lesion Count - Week 12 | 25.3 Lesions | Standard Deviation 17.56 |
| Acne Mask | Global Face Total Lesion Count - Week 12 | 21.7 Lesions | Standard Deviation 17.58 |
Secondary
Global Face Total Lesion Count - Week 2
Sum of inflammatory and non-inflammatory lesions
Time frame: 2 weeks
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Global Face Total Lesion Count - Week 2 | 34.8 Lesions | Standard Deviation 19.3 |
| Acne Mask | Global Face Total Lesion Count - Week 2 | 28.6 Lesions | Standard Deviation 13.1 |
Secondary
Global Face Total Lesion Count - Week 4
Sum of inflammatory and non-inflammatory lesions
Time frame: 4 weeks
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Global Face Total Lesion Count - Week 4 | 32.8 Lesions | Standard Deviation 20.1 |
| Acne Mask | Global Face Total Lesion Count - Week 4 | 25.2 Lesions | Standard Deviation 13.53 |
Secondary
Global Face Total Lesion Count - Week 8
Sum of inflammatory and non-inflammatory lesions
Time frame: 8 weeks
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Global Face Total Lesion Count - Week 8 | 27.7 Lesions | Standard Deviation 17.41 |
| Acne Mask | Global Face Total Lesion Count - Week 8 | 22.5 Lesions | Standard Deviation 13.95 |
Secondary
Investigator Global Acne Assessment - Week 1
Investigator Global Acne Assessment using Modified Cooke's Scale - Week 1. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed.
Time frame: 1 week
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Investigator Global Acne Assessment - Week 1 | 2.29 Units on a scale | Standard Deviation 0.444 |
| Acne Mask | Investigator Global Acne Assessment - Week 1 | 2.27 Units on a scale | Standard Deviation 0.427 |
Secondary
Investigator Global Acne Assessment - Week 12
Investigator Global Acne Assessment using Modified Cooke's Scale - Week 12. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed.
Time frame: 12 weeks
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Investigator Global Acne Assessment - Week 12 | 1.64 Units on a scale | Standard Deviation 0.724 |
| Acne Mask | Investigator Global Acne Assessment - Week 12 | 1.64 Units on a scale | Standard Deviation 0.589 |
Secondary
Investigator Global Acne Assessment - Week 2
Investigator Global Acne Assessment using Modified Cooke's Scale - Week 2. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed.
Time frame: 2 weeks
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Investigator Global Acne Assessment - Week 2 | 2.17 Units on a scale | Standard Deviation 0.5 |
| Acne Mask | Investigator Global Acne Assessment - Week 2 | 2.06 Units on a scale | Standard Deviation 0.47 |
Secondary
Investigator Global Acne Assessment - Week 4
Investigator Global Acne Assessment using Modified Cooke's Scale - Week 4. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed.
Time frame: 4 weeks
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Investigator Global Acne Assessment - Week 4 | 2.00 Units on a scale | Standard Deviation 0.587 |
| Acne Mask | Investigator Global Acne Assessment - Week 4 | 1.90 Units on a scale | Standard Deviation 0.583 |
Secondary
Investigator Global Acne Assessment - Week 8
Investigator Global Acne Assessment using Modified Cooke's Scale - Week 8. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed.
Time frame: 8 weeks
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Investigator Global Acne Assessment - Week 8 | 1.84 Units on a scale | Standard Deviation 0.669 |
| Acne Mask | Investigator Global Acne Assessment - Week 8 | 1.73 Units on a scale | Standard Deviation 0.6 |
Secondary
Overall Redness of Inflammatory Lesions - Week 1
Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness
Time frame: 1 week
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Overall Redness of Inflammatory Lesions - Week 1 | 4.88 Units on a scale | Standard Deviation 1.222 |
| Acne Mask | Overall Redness of Inflammatory Lesions - Week 1 | 5.05 Units on a scale | Standard Deviation 1.278 |
Secondary
Overall Redness of Inflammatory Lesions - Week 12
Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness
Time frame: 12 weeks
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Overall Redness of Inflammatory Lesions - Week 12 | 3.96 Units on a scale | Standard Deviation 1.346 |
| Acne Mask | Overall Redness of Inflammatory Lesions - Week 12 | 3.97 Units on a scale | Standard Deviation 1.282 |
Secondary
Overall Redness of Inflammatory Lesions - Week 2
Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness
Time frame: 2 weeks
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Overall Redness of Inflammatory Lesions - Week 2 | 4.65 Units on a scale | Standard Deviation 1.183 |
| Acne Mask | Overall Redness of Inflammatory Lesions - Week 2 | 4.74 Units on a scale | Standard Deviation 1.202 |
Secondary
Overall Redness of Inflammatory Lesions - Week 4
Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness
Time frame: 4 weeks
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Overall Redness of Inflammatory Lesions - Week 4 | 4.49 Units on a scale | Standard Deviation 1.291 |
| Acne Mask | Overall Redness of Inflammatory Lesions - Week 4 | 4.41 Units on a scale | Standard Deviation 1.318 |
Secondary
Overall Redness of Inflammatory Lesions - Week 8
Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness
Time frame: 8 weeks
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Overall Redness of Inflammatory Lesions - Week 8 | 4.30 Units on a scale | Standard Deviation 1.278 |
| Acne Mask | Overall Redness of Inflammatory Lesions - Week 8 | 4.25 Units on a scale | Standard Deviation 1.446 |
Secondary
Overall Size of Inflammatory Lesions - Week 1
Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large
Time frame: 1 week
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Overall Size of Inflammatory Lesions - Week 1 | 4.58 Units on a scale | Standard Deviation 1.298 |
| Acne Mask | Overall Size of Inflammatory Lesions - Week 1 | 4.83 Units on a scale | Standard Deviation 1.371 |
Secondary
Overall Size of Inflammatory Lesions - Week 12
Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large
Time frame: 12 weeks
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Overall Size of Inflammatory Lesions - Week 12 | 3.67 Units on a scale | Standard Deviation 1.305 |
| Acne Mask | Overall Size of Inflammatory Lesions - Week 12 | 3.59 Units on a scale | Standard Deviation 1.411 |
Secondary
Overall Size of Inflammatory Lesions - Week 2
Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large
Time frame: 2 weeks
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Overall Size of Inflammatory Lesions - Week 2 | 4.17 Units on a scale | Standard Deviation 1.129 |
| Acne Mask | Overall Size of Inflammatory Lesions - Week 2 | 4.56 Units on a scale | Standard Deviation 1.222 |
Secondary
Overall Size of Inflammatory Lesions - Week 4
Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large
Time frame: 4 weeks
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Overall Size of Inflammatory Lesions - Week 4 | 4.07 Units on a scale | Standard Deviation 1.273 |
| Acne Mask | Overall Size of Inflammatory Lesions - Week 4 | 4.15 Units on a scale | Standard Deviation 1.408 |
Secondary
Overall Size of Inflammatory Lesions - Week 8
Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large.
Time frame: 8 weeks
Population: Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gel-Cream + Acne Mask | Overall Size of Inflammatory Lesions - Week 8 | 3.88 Units on a scale | Standard Deviation 1.29 |
| Acne Mask | Overall Size of Inflammatory Lesions - Week 8 | 3.85 Units on a scale | Standard Deviation 1.606 |