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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The purpose of this study is to compare the tolerability of topical combination therapies in the treatment of facial acne.
The purpose of this study is to compare the tolerability of topical combination therapies in the treatment of facial acne.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clindoxyl Gel | Experimental | Subject will apply both study products in a split-face fashion. Study products will be applied once-daily in the evening. |
|
| Epiduo gel | Active Comparator | Subject will apply both study products in a split-face fashion. Study products will be applied once-daily in the evening. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BENZOYL PEROXIDE/ CLINDAMYCIN | Drug | Commencing at baseline, subjects will apply once daily both treatment arm #1 and treatment arm #2 in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. At 2 weeks, subjects will apply benzoyl peroxide/clindamycin gel to the entire face for an additional 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Erythema (Redness) | Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. | Weeks 1 and 2 |
| Skin Dryness | Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. | Weeks 1 and 2 |
| Skin Peeling | Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3,Intense. | Weeks 1 and 2 |
| Irritant/Allergic Contact Dermatitis | Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. | Weeks 1 and 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Erythema (Redness) | Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. | Weeks 5 and 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Investigación y Prevencion de Enfermidades Cardiovasculares | Ciudad Autonoma de Buenos Aires | Buenos Aires | 1119 | Argentina | ||
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 114544 | Clinical Study Report | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Clinical research center
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| ID | Title | Description |
|---|---|---|
| FG000 | Clindoxyl and Epiduo Gels | Commencing at baseline, participants will apply clindoxyl and epiduo gels once daily in a bilateral split-face fashion (Split Face Treatment Period; allocation to left and right side randomly assigned) for an initial 2 weeks. At Week 5, during the Full Face Treatment Period, participants will apply clindoxyl gel to the entire face for an additional 4 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Split Face Treatment (Weeks 1 and 2) |
| |||||||||||||
| Full Face Treatment (Weeks 5 and 8) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Clindoxyl and Epiduo Gels | Commencing at baseline, participants will apply clindoxyl and epiduo gels once daily in a bilateral split-face fashion (Split Face Treatment Period; allocation to left and right side randomly assigned) for an initial 2 weeks. At Week 5, during the Full Face Treatment Period, participants will apply clindoxyl gel to the entire face for an additional 4 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Erythema (Redness) | Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. | Intent-to-Treat (ITT) | Posted | Mean | Standard Deviation | units on a scale | Weeks 1 and 2 |
|
Baseline through Week 8.
Any study product-related AEs ongoing at the end of the treatment period will be followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs will be followed until resolution as previously stated for study product-related AEs.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Clindoxyl and Epiduo Gels | Commencing at baseline, participants will apply clindoxyl and epiduo gels once daily in a bilateral split-face fashion (Split Face Treatment Period; allocation to left and right side randomly assigned) for an initial 2 weeks. At Week 5, during the Full Face Treatment Period, participants will apply clindoxyl gel to the entire face for an additional 4 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site irritation | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 888-435-7343 |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| C466951 | clindamycin phosphate benzoyl peroxide combination |
| D001585 | Benzoyl Peroxide |
| D000068816 | Adapalene |
| ID | Term |
|---|---|
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| BENZOYL PEROXIDE/ ADAPALENE | Drug | Commencing at baseline, subjects will apply once daily both treatment arm #1 and treatment arm #2 in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. At 2 weeks, subjects will apply benzoyl peroxide/clindamycin gel to the entire face for an additional 6 weeks. |
|
| Skin Dryness |
Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. |
| Weeks 5 and 8 |
| Skin Peeling | Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. | Weeks 5 and 8 |
| Irritant/Allergic Contact Dermatitis | Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. | Weeks 5 and 8 |
| Investigators Static Global Assessment | ISGA is evaluated using the following scale: 0, Clear: Clear skin with no lesions; 1, Almost Clear: Rare non-inflammatory lesions; 2, Mild: Some non-inflammatory lesions with no more than a few inflammatory lesions but no nodular lesions); 3, Moderate: Up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 small nodular lesion; 4, Severe: Up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions; 5, Very Severe: Many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions. | Baseline, Weeks 5, 8 |
| Total Acne Lesion Counts | Total acne lesion counts - includes both inflammatory acne lesions (pustules, papules), noninflammatory lesions (whiteheads and blackheads), | Baseline, Weeks 5 and 8 |
| Inflammatory Acne Lesion Counts | Total number of inflammatory acne lesions (pustules, papules) at each timepoint. | Baseline, Weeks 5 and 8 |
| Non-inflammatory Acne Lesion Counts | Total number of non-inflammatory acne lesions (whiteheads and blackheads) at each timepoint. | Baseline, Weeks 5 and 8 |
| Skindex-29 Quality of Life Questionnaire (QoL) - Symptomatic Domain | Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. The symptomatic score (score=0 to 28)=(sum of the 7 individual item scores) * 100/28. | Baseline, Weeks 2 and 8 |
| Quality of Life Questionnaire - Emotional Domain | Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. The emotional score (score=0 to 40)=(sum of the 10 individual item scores) * 100/40. | Baseline, Weeks 2 and 8 |
| Quality of Life Questionnaire - Functional Domain | Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. The functional score (score=0 to 48)=(sum of the 12 individual item scores) * 100/48. | Baseline, Weeks 2 and 8 |
| Quality of Life Questionnaire - Global Score | Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. A Global Score (range 0-100)=(sum of all 29 individual item scores) * 100/116. | Baseline, Weeks 2 and 8 |
| Product Acceptability and Preference Questionnaire - Severity of Redness at Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. | Weeks 1 and 2 |
| Product Acceptability and Preference Questionnaire - Severity of Redness at Week 8 | Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. | Week 8 |
| Product Acceptability and Preference Questionnaire - Severity of Dryness at Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. | Weeks 1 and 2 |
| Product Acceptability and Preference Questionnaire - Severity of Dryness at Week 8 | Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. | Week 8 |
| Product Acceptability and Preference Questionnaire - Severity of Burning at Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. | Weeks 1 and 2 |
| Product Acceptability and Preference Questionnaire - Severity of Burning at Week 8 | Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. | Week 8 |
| Product Acceptability and Preference Questionnaire - Severity of Itching at Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. | Weeks 1 and 2 |
| Product Acceptability and Preference Questionnaire - Severity of Itching at Week 8 | Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. | Week 8 |
| Product Acceptability and Preference Questionnaire - Severity of Scaling at Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe; 5, Very Severe. | Weeks 1 and 2 |
| Product Acceptability and Preference Questionnaire - Severity of Scaling at Week 8 | Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe; 5, Very Severe. | Week 8 |
| Product Acceptability and Preference Questionnaire - Ease of Application of Product at Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very easy; 2, Easy; 3, Neutral; 4, Difficult. | Weeks 1 and 2 |
| Product Acceptability and Preference Questionnaire - Ease of Application of Product at Week 8 | Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, Very easy; 2, Easy; 3, Neutral; 4, Difficult. | Week 8 |
| Product Acceptability and Preference Questionnaire - Comfort of Skin at Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Comfortable; 2, Comfortable; 3, Somewhat Comfortable; 4, Somewhat Uncomfortable; 5, Uncomfortable. | Weeks 1 and 2 |
| Product Acceptability and Preference Questionnaire - Comfort of Skin at Week 8 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Comfortable; 2, Comfortable; 3, Somewhat Comfortable; 4, Somewhat Uncomfortable; 5, Uncomfortable. | Week 8 |
| Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With? at Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following choices: Epiduo, Clindoxyl Gel, Both Treatments Equally. | Weeks 1 and 2 |
| Product Acceptability and Preference Questionnaire - Comparison of Study Products Used in the Past at Week 8 | Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, More Satisfied; 2, Somewhat More Satisfied; 3, Neither Satisfied or Dissatisfied; 4, Somewhat More Dissatisfied; 5, More Dissatisfied. | Week 8 |
| Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Highly Favorable; 2, Favorable; 3, Neutral; 4, Unfavorable; 5, Uncomfortable. | Weeks 1 and 2 |
| Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Week 8 | Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, Highly Favorable; 2, Favorable; 3, Neutral; 4, Unfavorable; 5, More Dissatisfied. | Week 8 |
| Product Acceptability and Preference Questionnaire - Compliance at Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, Not Compliant at all; 1, Mostly Compliant; 2, Very Compliant. | Weeks 1 and 2 |
| Product Acceptability and Preference Questionnaire - Compliance at Week 8 | Product Acceptability and Preference Questionnaire were completed by the subject at week 8 by answering Yes or No to the following question: Did you use the product every day?. When only one product was applied to the face, subjects were asked to rate their compliance by answering the aforementioned question, rather than rating compliance on a 0-2 scale. | Week 8 |
| Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint by answering Yes or No to the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product? | Weeks 1 and 2 |
| Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Week 8 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint by answering Yes or No to the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product? | Week 8 |
| Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint by answering Yes or No to the following question: If you were to choose to continue treatment for your acne, would you use the study product? | Weeks 1 and 2 |
| Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 8 | Product Acceptability and Preference Questionnaire were completed by the subject at 8 week timepoint by answering Yes or No to the following question: If you were to choose to continue treatment for your acne, would you use the study product? | Week 8 |
| Product Acceptability and Preference Questionnaire - Ease of Use Wtih Make-Up at Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, Not Applicable; 1, Very Easy; 2, Easy; 3, Neutral; 4, Difficult; 5, Very Difficult. | Weeks 1 and 2 |
| Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up at Week 8 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, Not Applicable; 1, Very Easy; 2, Easy; 3, Neutral; 4, Difficult; 5, Very Difficult. | Week 8 |
| Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Satisfied; 2, Satisfied; 3, Neutral; 4, Unsatisfied; 5, Very Unsatisfied. | Weeks 1 and 2 |
| Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Week 8 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Satisfied; 2, Satisfied; 3, Neutral; 4, Unsatisfied; 5, Very Unsatisfied. | Week 8 |
| Hospital Italiano de Buenos Aires |
| Ciudad Autonoma de Buenos Aires |
| Buenos Aires |
| 1181 ACH |
| Argentina |
| LUMIPIEL - Centro Dermatológico | Ciudad Autonoma de Buenos Aires | Buenos Aires | 1181 ACH | Argentina |
| Buenos Aires Skin | Ciudad de Buenos Aires | Buenos Aires | C1055AAO | Argentina |
For additional information about this study please refer to the GSK Clinical Study Register |
| 114544 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114544 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114544 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114544 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
|
| years |
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| Gender | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Investigators Static Global Assessment (ISGA) | The investigator rated the participants' skin using the 6-point ISGA: 0=clear, clear skin with no inflammatory lesions (ILs) or non-ILs; 1=almost clear, rare non-ILs with no more than one small IL; 2=mild, some non-ILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many non-ILs and may have some ILs, but no more than one small NL; 4=severe, up to many non-IL and ILs, but no more than a few NLs; 5=many non-IL and ILs and more than a few NLs. May have cystic lesions. Participants with grades of 2-4 were eligible for enrollment in this study. | Number | Participants |
|
| Inflammatory Acne Lesion Count | Inflammatory acne lesion count at baseline (number of pustules and papules). | Mean | Standard Deviation | Inflammatory lesions |
|
| Non-Inflammatory Acne Lesion Count | Non-Inflammatory acne lesion count at baseline (number of whiteheads and blackheads) | Mean | Standard Deviation | Non-Infammatory acne lesions |
|
| Total Acne Lesion Count | Total acne lesion count (includes inflammatory and non-inflammatory lesions) | Mean | Standard Deviation | Acne lesions |
|
|
|
| Secondary | Erythema (Redness) | Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. | ITT | Posted | Mean | Standard Deviation | units on a scale | Weeks 5 and 8 |
|
|
|
| Secondary | Skin Dryness | Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. | ITT | Posted | Mean | Standard Deviation | units on a scale | Weeks 5 and 8 |
|
|
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| Primary | Skin Dryness | Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. | ITT | Posted | Mean | Standard Deviation | units on a scale | Weeks 1 and 2 |
|
|
|
| Primary | Skin Peeling | Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3,Intense. | ITT | Posted | Mean | Standard Deviation | units on a scale | Weeks 1 and 2 |
|
|
|
| Primary | Irritant/Allergic Contact Dermatitis | Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. | ITT | Posted | Mean | Standard Deviation | units on a scale | Weeks 1 and 2 |
|
|
|
| Secondary | Skin Peeling | Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. | ITT | Posted | Mean | Standard Deviation | units on a scale | Weeks 5 and 8 |
|
|
|
| Secondary | Irritant/Allergic Contact Dermatitis | Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face. Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. | ITT | Posted | Mean | Standard Deviation | units on a scale | Weeks 5 and 8 |
|
|
|
| Secondary | Investigators Static Global Assessment | ISGA is evaluated using the following scale: 0, Clear: Clear skin with no lesions; 1, Almost Clear: Rare non-inflammatory lesions; 2, Mild: Some non-inflammatory lesions with no more than a few inflammatory lesions but no nodular lesions); 3, Moderate: Up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 small nodular lesion; 4, Severe: Up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions; 5, Very Severe: Many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions. | For the first 2 weeks, participants apply one of the drugs (Clindoxyl or Epiduo) to one side of the face and the other drug to the other side of their face. After week 2, participants apply Clindoxyl to their entire face and do not use Epiduo. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 5, 8 |
|
|
|
| Secondary | Total Acne Lesion Counts | Total acne lesion counts - includes both inflammatory acne lesions (pustules, papules), noninflammatory lesions (whiteheads and blackheads), | ITT | Posted | Mean | Standard Deviation | Acne Lesions | Baseline, Weeks 5 and 8 |
|
|
|
| Secondary | Inflammatory Acne Lesion Counts | Total number of inflammatory acne lesions (pustules, papules) at each timepoint. | ITT | Posted | Mean | Standard Deviation | Acne Lesions | Baseline, Weeks 5 and 8 |
|
|
|
| Secondary | Non-inflammatory Acne Lesion Counts | Total number of non-inflammatory acne lesions (whiteheads and blackheads) at each timepoint. | ITT | Posted | Mean | Standard Deviation | Acne Lesions | Baseline, Weeks 5 and 8 |
|
|
|
| Secondary | Skindex-29 Quality of Life Questionnaire (QoL) - Symptomatic Domain | Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. The symptomatic score (score=0 to 28)=(sum of the 7 individual item scores) * 100/28. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Weeks 2 and 8 |
|
|
|
| Secondary | Quality of Life Questionnaire - Emotional Domain | Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. The emotional score (score=0 to 40)=(sum of the 10 individual item scores) * 100/40. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Weeks 2 and 8 |
|
|
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| Secondary | Quality of Life Questionnaire - Functional Domain | Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. The functional score (score=0 to 48)=(sum of the 12 individual item scores) * 100/48. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Weeks 2 and 8 |
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| Secondary | Quality of Life Questionnaire - Global Score | Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. A Global Score (range 0-100)=(sum of all 29 individual item scores) * 100/116. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Weeks 2 and 8 |
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| Secondary | Product Acceptability and Preference Questionnaire - Severity of Redness at Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Weeks 1 and 2 |
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| Secondary | Product Acceptability and Preference Questionnaire - Severity of Redness at Week 8 | Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Week 8 |
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| Secondary | Product Acceptability and Preference Questionnaire - Severity of Dryness at Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Weeks 1 and 2 |
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| Secondary | Product Acceptability and Preference Questionnaire - Severity of Dryness at Week 8 | Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Week 8 |
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| Secondary | Product Acceptability and Preference Questionnaire - Severity of Burning at Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Weeks 1 and 2 |
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| Secondary | Product Acceptability and Preference Questionnaire - Severity of Burning at Week 8 | Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Week 8 |
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| Secondary | Product Acceptability and Preference Questionnaire - Severity of Itching at Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Weeks 1 and 2 |
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| Secondary | Product Acceptability and Preference Questionnaire - Severity of Itching at Week 8 | Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Week 8 |
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| Secondary | Product Acceptability and Preference Questionnaire - Severity of Scaling at Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe; 5, Very Severe. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Weeks 1 and 2 |
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| Secondary | Product Acceptability and Preference Questionnaire - Severity of Scaling at Week 8 | Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe; 5, Very Severe. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Week 8 |
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| Secondary | Product Acceptability and Preference Questionnaire - Ease of Application of Product at Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very easy; 2, Easy; 3, Neutral; 4, Difficult. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Weeks 1 and 2 |
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| Secondary | Product Acceptability and Preference Questionnaire - Ease of Application of Product at Week 8 | Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, Very easy; 2, Easy; 3, Neutral; 4, Difficult. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Week 8 |
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| Secondary | Product Acceptability and Preference Questionnaire - Comfort of Skin at Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Comfortable; 2, Comfortable; 3, Somewhat Comfortable; 4, Somewhat Uncomfortable; 5, Uncomfortable. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Weeks 1 and 2 |
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| Secondary | Product Acceptability and Preference Questionnaire - Comfort of Skin at Week 8 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Comfortable; 2, Comfortable; 3, Somewhat Comfortable; 4, Somewhat Uncomfortable; 5, Uncomfortable. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Week 8 |
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| Secondary | Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With? at Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following choices: Epiduo, Clindoxyl Gel, Both Treatments Equally. | ITT. Data are presented for only those participants completing the questionnaire. | Posted | Number | Participants | Weeks 1 and 2 |
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| Secondary | Product Acceptability and Preference Questionnaire - Comparison of Study Products Used in the Past at Week 8 | Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, More Satisfied; 2, Somewhat More Satisfied; 3, Neither Satisfied or Dissatisfied; 4, Somewhat More Dissatisfied; 5, More Dissatisfied. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Week 8 |
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| Secondary | Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Highly Favorable; 2, Favorable; 3, Neutral; 4, Unfavorable; 5, Uncomfortable. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Weeks 1 and 2 |
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| Secondary | Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Week 8 | Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, Highly Favorable; 2, Favorable; 3, Neutral; 4, Unfavorable; 5, More Dissatisfied. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Week 8 |
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| Secondary | Product Acceptability and Preference Questionnaire - Compliance at Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, Not Compliant at all; 1, Mostly Compliant; 2, Very Compliant. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Weeks 1 and 2 |
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| Secondary | Product Acceptability and Preference Questionnaire - Compliance at Week 8 | Product Acceptability and Preference Questionnaire were completed by the subject at week 8 by answering Yes or No to the following question: Did you use the product every day?. When only one product was applied to the face, subjects were asked to rate their compliance by answering the aforementioned question, rather than rating compliance on a 0-2 scale. | ITT | Posted | Number | Participants | Week 8 |
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| Secondary | Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint by answering Yes or No to the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product? | ITT | Posted | Number | Participants | Weeks 1 and 2 |
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| Secondary | Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Week 8 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint by answering Yes or No to the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product? | ITT | Posted | Number | Participants | Week 8 |
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| Secondary | Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint by answering Yes or No to the following question: If you were to choose to continue treatment for your acne, would you use the study product? | ITT | Posted | Number | Participants | Weeks 1 and 2 |
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| Secondary | Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 8 | Product Acceptability and Preference Questionnaire were completed by the subject at 8 week timepoint by answering Yes or No to the following question: If you were to choose to continue treatment for your acne, would you use the study product? | ITT | Posted | Number | Participants | Week 8 |
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| Secondary | Product Acceptability and Preference Questionnaire - Ease of Use Wtih Make-Up at Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, Not Applicable; 1, Very Easy; 2, Easy; 3, Neutral; 4, Difficult; 5, Very Difficult. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Weeks 1 and 2 |
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| Secondary | Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up at Week 8 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, Not Applicable; 1, Very Easy; 2, Easy; 3, Neutral; 4, Difficult; 5, Very Difficult. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Week 8 |
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| Secondary | Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Weeks 1 and 2 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Satisfied; 2, Satisfied; 3, Neutral; 4, Unsatisfied; 5, Very Unsatisfied. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Weeks 1 and 2 |
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| Secondary | Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Week 8 | Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Satisfied; 2, Satisfied; 3, Neutral; 4, Unsatisfied; 5, Very Unsatisfied. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Week 8 |
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| 0 |
| 48 |
| 44 |
| 48 |
| Application site dryness | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Application site pruritus | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Application site exfoliation | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Drug intolerance | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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If the Investigator wishes to make any such publication or presentation, the Investigator must first submit such publication or presentation to Stiefel for review at least thirty (30) days prior to the date on which such publication or presentation is proposed to be made.
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
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| Week 2, Epiduo Gel, n=46 |
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| Week 2, Clindoxyl Gel, n=46 |
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| Week 2, Both Treatments Equally, n=46 |
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| Week 2 - Yes |
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| Week 2 - No |
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| Week 2 - Yes |
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| Week 2 - No |
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