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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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Multi-center, single-blind, randomized, comparative, split-face study. The duration of the study is 8 weeks. Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide gel and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Multi-center, single-blind, randomized, comparative, split-face study. The duration of the study is 8 weeks and consists of a baseline visit and visits at weeks 1, 2, 5 and 8. Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide gel and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3 subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Blinding This is an investigator-blinded study; therefore, subjects and study-center staff will not be blinded to study treatment allocation (ie, left vs. right side application). During the first 2 weeks, the investigator will be unaware of which study product is being used on either side of the face. Subjects and study-center staff will be instructed not to reveal study treatment allocation to the investigator. Subjects will be instructed not to use study product in the presence of the investigator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duac gel | Experimental | Subjects will apply Duac gel once a day to one-half of their face and and apply Epiduo gel on the other side of their face once daily for the first 2 weeks. |
|
| Epiduo gel | Active Comparator | Subjects will apply Duac gel once a day to one-half of their face and and apply Epiduo gel on the other side of their face once daily for the first 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clindamycin and benzoyl peroxide gel (Duac® Topical Gel) | Drug | Subjects will apply Duac(clindamycin and benzoyl peroxide) gel to one-half of their face and and apply Epiduo (benzoyl peroxide/adapalene) gel on the other side of their face once a day for the first 2 weeks. Starting at week 2, subjects will apply Duac (benzoyl peroxide/clindamycin gel) to the entire face for an additional 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Skin Dryness Score | Investigator assessment of tolerability (skin dryness) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. | Week 1, Week 2 |
| Skin Peeling Score | Investigator assessment of tolerability (skin peeling) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; Intense, 3. | Week 1, Week 2 |
| Irritant/Allergic Contact Dermatitis Score | Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis) on the face. Erythema,peeling, and dryness were graded using the following scale: 0 None
| Week 1, Week 2 |
| Erythema (Redness) Score | Investigator assessment of tolerability (irritant/allergic contact dermatitis) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. | Week 1, Week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Erythema (Redness) Score | Investigator assessment of tolerability (erythema) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. | Week 5, Week 8 |
| Skin Dryness Score |
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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 |
|---|---|---|---|---|---|---|
| Aesthetics, Skin Care & Dermasurgery | Rockville | Maryland | 20850 | United States | ||
| Grekin Skin Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23174047 | Background | Gonzalez P, Vila R, Cirigliano M. The tolerability profile of clindamycin 1%/benzoyl peroxide 5% gel vs. adapalene 0.1%/benzoyl peroxide 2.5% gel for facial acne: results of a randomized, single-blind, split-face study. J Cosmet Dermatol. 2012 Dec;11(4):251-60. doi: 10.1111/jocd.12013. |
| 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 |
|---|---|---|---|
| 114547 | Study Protocol | 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 centers
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 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 | All Study Participants | Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Skin Dryness Score | Investigator assessment of tolerability (skin dryness) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. | Intent-to-Treat (ITT) Population | Posted | Mean | Standard Deviation | Units on a scale | Week 1, Week 2 |
|
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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 | All Study Participants | Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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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 |
|---|---|
| D002981 | Clindamycin |
| D001585 | Benzoyl Peroxide |
| ID | Term |
|---|---|
| D008034 | Lincomycin |
| D055231 | Lincosamides |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
|
| benzoyl peroxide and adapalene gel (EPIDUO™ Gel) | Drug | Subjects will apply Duac(clindamycin and benzoyl peroxide) gel to one-half of their face and and apply Epiduo (benzoyl peroxide/adapalene) gel on the other side of their face once a day for the first 2 weeks. Starting at week 2, subjects will apply Duac (benzoyl peroxide/clindamycin gel) to the entire face for an additional 6 weeks. |
|
|
Investigator assessment of tolerability (skin dryness) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. |
| Week 5, Week 8 |
| Skin Peeling Score | Investigator assessment of tolerability (skin peeling) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. | Week 5, Week 8 |
| Irritant/Allergic Contact Dermatitis Score | Investigator assessment of tolerability (contact dermatitis) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. | Week 5, Week 8 |
| Investigator Static Global Assessment Score | 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. | Week 5, Week 8 |
| Inflammatory Acne Lesion Counts | Total number of inflammatory acne lesions (pustules, papules) at each timepoint. | Week 5, Week 8 |
| Non-Inflammatory Acne Lesion Counts | Total number of non-inflammatory acne lesions (whiteheads and blackheads) at each timepoint. | Week 5, Week 8 |
| Total Acne Lesion Counts | Total acne lesion counts - includes both inflammatory acne lesions (pustules, papules), noninflammatory lesions (whiteheads and blackheads), | Week 5, Week 8 |
| Skindex-29 Quality of Life Questionnaire - Symptomatic Domain | Skindex-29 Quality of Life (QoL) Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: "never" to "all the time", higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain. | Baseline, and Week 8 |
| Skindex-29 Quality of Life Questionnaire - Emotional Domain | Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: "never" to "all the time", higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain. | Baseline, and Week 8 |
| Skindex-29 Quality of Life Questionnaire - Functional Domain | Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: "never" to "all the time", higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain. | Baseline, and Week 8 |
| Skindex-29 Quality of Life Questionnaire - Global Score | Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: "never" to "all the time", higher scores for each domain indicate worse effects on QoL. The Global Score ranges from 0 to 100. Higher scores indicate worse QoL for that domain. | Baseline, and Week 8 |
| Product Acceptability and Preference Questionnaire - Severity of Redness | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. | Week 1, Week 2 |
| Product Acceptability and Preference Questionnaire - Severity of Redness | 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 - Severity of Dryness | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. | Week 1, Week 2 |
| Product Acceptability and Preference Questionnaire - Severity of Dryness | 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 - Severity of Burning | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. | Week 1, Week 2 |
| Product Acceptability and Preference Questionnaire - Severity of Burning | 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 - Severity of Itching | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. | Week 1, Week 2 |
| Product Acceptability and Preference Questionnaire - Severity of Itching | 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 - Severity of Scaling | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. | Week 1, Week 2 |
| Product Acceptability and Preference Questionnaire - Severity of Scaling | 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 | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very easy; 2, easy; 3, neutral; 4, difficult; 5, very difficult. | Week 1, Week 2 |
| Product Acceptability and Preference Questionnaire - Ease of Application of Product | 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; 5, very difficult. | Week 8 |
| Product Acceptability and Preference Questionnaire - Comfort of Skin | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very comfortable; 2, comfortable; 3, somewhat comfortable; 4, somewhat uncomfortable; 5, uncomfortable. | Week 1, Week 2 |
| Product Acceptability and Preference Questionnaire - Comfort of Skin | Product Acceptability and Preference Questionnaire was completed by the subject at week 8 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? | Product Acceptability and Preference Questionnaire was completed by the subject at week 1 and week 2 asking which study product they were more satisfied with: Duac or Epiduo. | Week 1, Week 2 |
| Product Acceptability and Preference Questionnaire - Comparison of Study Products to Products Used in the Past | 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, more satisfied; 5, more dissatisfied. | Week 8 |
| Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, highly favorable; 2, favorable; 3, neutral; 4, unfavorable; 5, highly unfavorable. | Week 1, Week 2 |
| Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products | 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, highly unfavorable. | Week 8 |
| Product Acceptability and Preference Questionnaire - Compliance | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, non-compliant (< 50% of the week); 1, mostly compliant (50-79%); 2, very compliant (80-100%). | Week 1, Week 2 |
| Product Acceptability and Preference Questionnaire - Compliance | Subject response to question regarding use of the product every day or not at week 8 time point answering Yes or No | Week 8 |
| Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin | Subject response to question: did you feel that your skin was hydrated and moisturized while you on your study product? (Yes or No). | Week 1, Week 2 |
| Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin | Subject response to question: did you feel that your skin was hydrated and moisturized while you on your study product? (Yes or No). | Week 8 |
| Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment | Subject response to the following question: If you were to choose to continue treatment for your acne, which treatment would you choose? (Yes or No). | Week 1, Week 2 |
| Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment | Subject response to the following question: If you were to choose to continue treatment for your acne, which treatment would you choose? (Yes or No). | Week 8 |
| Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, not applicable; 1, very easy; 2, easy; 3, neutral; 4, difficult. | Week 1, Week 2 |
| Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up | Measure Description Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, not applicable; 1, very easy; 2, easy; 3, neutral; 4, difficult. | Week 8 |
| Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very satisfied; 2, satisfied; 3, neutral; 4, unsatisfied; 5, very unsatisfied. | Week 1, Week 2 |
| Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product | Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very satisfied; 2, satisfied; 3, neutral; 4, unsatisfied; 5, very unsatisfied. | Week 8 |
| Warren |
| Michigan |
| 48088 |
| United States |
For additional information about this study please refer to the GSK Clinical Study Register |
| 114547 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114547 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114547 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114547 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114547 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114547 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Region of Enrollment | Number | participants |
|
| Investigators Static Global Assessment (ISGA) | Patients with the following ISGA grades were eligible for enrollment on this study: 0, Clear: clear skin with no inflammatory lesions (IL) or non-inflammatory lesions (NIL); 1, Almost clear: rare NIL with no more than one small IL; 2, Mild: some NIL with no more than a few IL (papules/pustules only, no nodular lesions); 3, Moderate: up to many NIL and may have some IL, but no more than one small nodular lesion; 4, Severe: up to many NIL and IL, but no more than a few small nodular lesions; 5, Very severe: many NIL and IL and more than a few nodular lesions. May have cystic lesions. | Number | Participants |
|
| Inflammatory Acne Lesion Count | Inflammatory acne lesion count at baseline (number of pustules and papules). | Mean | Standard Deviation | Inflammatory Lesion |
|
| Non-Inflammatory Acne Lesion Count | Non-Inflammatory acne lesion count at baseline (number of whiteheads and blackheads) | Mean | Standard Deviation | Non-Inflammatory lesion |
|
| Total Acne Lesion Count | Total acne lesion count (includes inflammatory and non-inflammatory lesions) | Mean | Standard Deviation | Acne lesions |
|
| Epiduo Gel |
Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks. |
|
|
| Primary | Skin Peeling Score | Investigator assessment of tolerability (skin peeling) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; Intense, 3. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Week 1, Week 2 |
|
|
|
| Primary | Irritant/Allergic Contact Dermatitis Score | Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis) on the face. Erythema,peeling, and dryness were graded using the following scale: 0 None
| ITT | Posted | Mean | Standard Deviation | Units on a scale | Week 1, Week 2 |
|
|
|
| Primary | Erythema (Redness) Score | Investigator assessment of tolerability (irritant/allergic contact dermatitis) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Week 1, Week 2 |
|
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| Secondary | Erythema (Redness) Score | Investigator assessment of tolerability (erythema) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Week 5, Week 8 |
|
|
|
| Secondary | Skin Dryness Score | Investigator assessment of tolerability (skin dryness) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Week 5, Week 8 |
|
|
|
| Secondary | Skin Peeling Score | Investigator assessment of tolerability (skin peeling) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Week 5, Week 8 |
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| Secondary | Irritant/Allergic Contact Dermatitis Score | Investigator assessment of tolerability (contact dermatitis) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Week 5, Week 8 |
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| Secondary | Investigator Static Global Assessment Score | 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. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Week 5, Week 8 |
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| Secondary | Inflammatory Acne Lesion Counts | Total number of inflammatory acne lesions (pustules, papules) at each timepoint. | ITT | Posted | Mean | Standard Deviation | inflammatory acne lesions | Week 5, Week 8 |
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| Secondary | Non-Inflammatory Acne Lesion Counts | Total number of non-inflammatory acne lesions (whiteheads and blackheads) at each timepoint. | ITT | Posted | Mean | Standard Deviation | non-inflammatory acne lesions | Week 5, Week 8 |
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| 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 | total acne lesions | Week 5, Week 8 |
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| Secondary | Skindex-29 Quality of Life Questionnaire - Symptomatic Domain | Skindex-29 Quality of Life (QoL) Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: "never" to "all the time", higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Baseline, and Week 8 |
|
|
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| Secondary | Skindex-29 Quality of Life Questionnaire - Emotional Domain | Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: "never" to "all the time", higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Baseline, and Week 8 |
|
|
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| Secondary | Skindex-29 Quality of Life Questionnaire - Functional Domain | Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: "never" to "all the time", higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Baseline, and Week 8 |
|
|
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| Secondary | Skindex-29 Quality of Life Questionnaire - Global Score | Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: "never" to "all the time", higher scores for each domain indicate worse effects on QoL. The Global Score ranges from 0 to 100. Higher scores indicate worse QoL for that domain. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Baseline, and Week 8 |
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| Secondary | Product Acceptability and Preference Questionnaire - Severity of Redness | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 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 1, Week 2 |
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| Secondary | Product Acceptability and Preference Questionnaire - Severity of Redness | 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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|
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| Secondary | Product Acceptability and Preference Questionnaire - Severity of Dryness | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 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 1, Week 2 |
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| Secondary | Product Acceptability and Preference Questionnaire - Severity of Dryness | 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 - Severity of Burning | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 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 1, Week 2 |
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| Secondary | Product Acceptability and Preference Questionnaire - Severity of Burning | 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 - Severity of Itching | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 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 1, Week 2 |
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| Secondary | Product Acceptability and Preference Questionnaire - Severity of Itching | 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 - Severity of Scaling | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 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 1, Week 2 |
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| Secondary | Product Acceptability and Preference Questionnaire - Severity of Scaling | 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 | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very easy; 2, easy; 3, neutral; 4, difficult; 5, very difficult. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Week 1, Week 2 |
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| Secondary | Product Acceptability and Preference Questionnaire - Ease of Application of Product | 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; 5, very 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 | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 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 1, Week 2 |
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| Secondary | Product Acceptability and Preference Questionnaire - Comfort of Skin | Product Acceptability and Preference Questionnaire was completed by the subject at week 8 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? | Product Acceptability and Preference Questionnaire was completed by the subject at week 1 and week 2 asking which study product they were more satisfied with: Duac or Epiduo. | ITT. Some participants missed a visit and therefore were not included in the number of participants analyzed for that visit. | Posted | Number | Participants | Week 1, Week 2 |
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| Secondary | Product Acceptability and Preference Questionnaire - Comparison of Study Products to Products Used in the Past | 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, more satisfied; 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 | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, highly favorable; 2, favorable; 3, neutral; 4, unfavorable; 5, highly unfavorable. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Week 1, Week 2 |
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| Secondary | Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products | 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, highly unfavorable. | ITT | Posted | Mean | Standard Deviation | Units on a scale | Week 8 |
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| Secondary | Product Acceptability and Preference Questionnaire - Compliance | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, non-compliant (< 50% of the week); 1, mostly compliant (50-79%); 2, very compliant (80-100%). | ITT | Posted | Mean | Standard Deviation | Units on a scale | Week 1, Week 2 |
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| Secondary | Product Acceptability and Preference Questionnaire - Compliance | Subject response to question regarding use of the product every day or not at week 8 time point answering Yes or No | ITT | Posted | Number | Participants | Week 8 |
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| Secondary | Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin | Subject response to question: did you feel that your skin was hydrated and moisturized while you on your study product? (Yes or No). | ITT | Posted | Number | Participants | Week 1, Week 2 |
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| Secondary | Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin | Subject response to question: did you feel that your skin was hydrated and moisturized while you on your study product? (Yes or No). | 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 | Subject response to the following question: If you were to choose to continue treatment for your acne, which treatment would you choose? (Yes or No). | ITT | Posted | Number | Participants | Week 1, Week 2 |
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| Secondary | Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment | Subject response to the following question: If you were to choose to continue treatment for your acne, which treatment would you choose? (Yes or No). | ITT | Posted | Number | Participants | Week 8 |
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| Secondary | Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, not applicable; 1, very easy; 2, easy; 3, neutral; 4, difficult. | ITT. All participants were asked to respond to the questionnaire. | Posted | Mean | Standard Deviation | Units on a scale | Week 1, Week 2 |
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| Secondary | Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up | Measure Description Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, not applicable; 1, very easy; 2, easy; 3, neutral; 4, difficult. | ITT. All participants were asked to respond to the questionnaire. | 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 | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 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 1, Week 2 |
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| Secondary | Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product | Product Acceptability and Preference Questionnaire was completed by the subject at week 8 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 |
| 28 |
| 0 |
| 28 |
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D006571 |
| Heterocyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| Week 2 - Yes |
|
| Week 2 - No |
|
| Week 2 - Yes |
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| Week 2 - No |
|