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| ID | Type | Description | Link |
|---|---|---|---|
| S194-SP-05/Duac |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The objectives of this clinical trial are to compare the quality of life of the subjects, the efficacy and the tolerance of Duac® Gel (gel formulation with a combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide), applied once daily, against Differin® Gel (gel with 0.1% adapalene), used once daily, in the treatment of mild to moderate acne vulgaris.
Acne vulgaris is a chronic inflammatory disease of the pilosebaceous unit. It is characterized by the formation of comedones, papules, pustules, nodules, cysts, maculae and scars, generally located on the face, chest and back. Acne pathogenesis is recognized as multifactorial.
Acne vulgaris is the most common dermatological disorder. It affects approximately 85% individuals at some point in their lives, generally between 12 and 24 years of age. Although acne is prevalent within this age range, it can persist for many years and its long-term physical and psychological implications can be significant.
There are several medicinal products used to treat acne. However, the therapeutic challenge remains, therefore it is essential to continue investigating effective strategies for the treatment of this disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duac Gel | Experimental | Duac Gel |
|
| Differin gel | Active Comparator | Differin gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duac Gel | Drug | Duac® Gel will be applied to the face once daily at night, for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline to Week 2 in the Global Score of the Participant-completed Skindex-29 Quality of Life (QoL) Questionnaire | Skindex-29 is a self-administered QoL questionnaire comprised of 29 items scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 items), symptomatic (7 items), and functional (12 items), with domain scores ranging from 0 to 40, 28, and 48, respectively. Lower scores = better QoL. A Global Score (range 0-100) was derived by multiplying the sum of the points for all 29 items by a constant (0.862). Change from Baseline was calculated as the value at Week 2 minus the value at Baseline (Week 0). | Baseline (Week 0) and Week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline to Week 12 for the Indicated Domain Scores and the Global Score of the Participant-completed Skindex-29 QoL Questionnaire | Skindex-29 is a self-administered QoL questionnaire comprised of 29 items scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 items), symptomatic (7 items), and functional (12 items), with domain scores ranging from 0 to 40, 28, and 48, respectively. Lower scores = better QoL. A Global Score (range 0-100) was derived by multiplying the sum of the points for all 29 items by a constant (0.862). Change from Baseline was calculated as the value at Week 2 minus the value at Baseline (Week 0). |
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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 |
|---|---|---|---|---|---|---|
| Hospital Abente y Lago in La Coruna | A Coruña | Spain | ||||
| Hospital Germans Trias I Pujol |
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| ID | Title | Description |
|---|---|---|
| FG000 | Duac Gel | Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks |
| FG001 | Differin Gel | Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Duac Gel | Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks |
| BG001 | Differin Gel |
| 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 | Mean Change From Baseline to Week 2 in the Global Score of the Participant-completed Skindex-29 Quality of Life (QoL) Questionnaire | Skindex-29 is a self-administered QoL questionnaire comprised of 29 items scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 items), symptomatic (7 items), and functional (12 items), with domain scores ranging from 0 to 40, 28, and 48, respectively. Lower scores = better QoL. A Global Score (range 0-100) was derived by multiplying the sum of the points for all 29 items by a constant (0.862). Change from Baseline was calculated as the value at Week 2 minus the value at Baseline (Week 0). | Intent-to-Treat (ITT) Population: all randomized participants (par.) who applied >= 1 dose of study product. Missing values were imputed using the last observation carried forward (LOCF, i.e., the last available observation was used to estimate subsequent missing data points) method. 1 par. in the Differin arm had no QoL data and was not analyzed. | Posted | Mean | Standard Deviation | scores on a scale | Baseline (Week 0) and 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 | Duac Gel | Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application Site Erythema | General disorders | MedDRA | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| 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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Not provided
| ID | Term |
|---|---|
| C466951 | clindamycin phosphate benzoyl peroxide combination |
| D000068816 | Adapalene |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Differin gel | Drug | Differin Gel will be applied to the face once daily at night, for 12 weeks. |
|
|
| Baseline (Week 0) and Week 12 |
| Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts | Lesions were counted on the entire face (defined as the area from the upper part of the jaw to the lower part of the hairline), excluding maculae and non-inflammatory lesions located on the nose or chin. Inflammatory lesions included papules, pustules, nodules, and cysts. Non-inflammatory lesions included closed comedones (whiteheads) and open comedones (blackheads). The total lesion count was calculated as the sum of inflammatory and non-inflammatory lesions. Change from Baseline was calculated as the values at Weeks 1, 2, 4, 8, and 12 minus the value at Baseline (Week 0). | Baseline (Week 0) and Weeks 1, 2, 4, 8, and 12 |
| Mean Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts | Lesions were counted on the entire face (defined as the area from the upper part of the jaw to the lower part of the hairline), excluding maculae and non-inflammatory lesions located on the nose or chin. Inflammatory lesions (IL) included papules, pustules, nodules, and cysts. Non-inflammatory lesions (NIL) included closed comedones (whiteheads) and open comedones (blackheads). Total lesion count was calculated as the sum of IL and NIL. Percent change from Baseline was calculated as the values at Weeks 1, 2, 4, 8, and 12 minus the value at Baseline divided by Baseline value * 100. | Baseline (Week 0) and Weeks 1, 2, 4, 8, and 12 |
| Correlation Between Skindex-29 Questionnaire Scores and Total Lesion Counts From Baseline to Week 2 | Analyses were performed to determine whether there was a correlation between the total lesion count and either the global or subdomain Skindex-29 questionnaire scores. Correlations between the Skindex-29 questionnaire scores and total lesion count from Baseline to Week 2 were assessed using Spearman's correlation coefficients, which ranges from -1 to 1. A score of 0 denotes no correlation, a score approaching 1 denotes correlation, and a score approaching -1 denotes inverse correlation. | Baseline (Week 0) and Week 2 |
| Mean Scores for Global Change in Acne Improvement at Weeks 1, 2, 4, 8, and 12 Compared to the Start of Treatment (Prior to Week 1) | Global change in acne improvement was assessed by the investigator on a 7-point scale: 1=greatly worsened, 2=significantly worsened, 3=slightly worsened, 4=no change, 5=slightly improved, 6=significantly improved, or 7=greatly improved. Global change at the indicated week was assessed in terms of change from the previous week. Change at Week 2, for example, was an assessment of change from Week 1. | Start of treatment and Weeks 1, 2, 4, 8, and 12 |
| Mean Scores for Self-evaluation of Acne Improvement at Weeks 1, 2, 4, 8, and 12 Compared to the Start of Treatment (Prior to Week 1) | Participants self-evaluated their acne improvement on a 3-point scale: 1=worsened, 2=no changes, and 3=improved. | Start of treatment and Weeks 1, 2, 4, 8, and 12 |
| Mean Acne Grades at Baseline and Weeks 1, 2, 4, 8, and 12 Assessed by the Leeds Revised Acne Grading System | The acne grade on the participant's face was assessed by the investigator using the LRAG, a photographic scale allowing for the assessment of the clinical status for acne severity for the face, back, and chest. It consists of a 12-grade scale (1, least severe; 12, most severe) for inflammatory visible lesions (les.). For non-inflammatory les., this scale comprises 3 photos of les. of increasing severity (grades 1-3). The scale provides a qualitative assessment of superficial/visible les. and provides consistency and inter-/intra-rater reliability. Grading was performed prior to les. counting. | Baseline (Week 0); Weeks 1, 2, 4, 8, and 12 |
| Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness | Tolerance symptoms of peeling (flaking), erythema (redness of skin), and dryness were evaluated at each visit by the investigator. Possible scores were: 0=absent, 1=mild intermittent, 2=mild persistent, 3=moderate intermittent, 4=moderate persistent, 5=severe intermittent, and 6=severe persistent. | Baseline (Week 0); Weeks 1, 2, 4, 8, and 12 |
| Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Itching and Burning | Tolerance symptoms of itching and burning were evaluated at each visit by participants. Possible scores were: 0=absent, 1=mild intermittent, 2=mild persistent, 3=moderate intermittent, 4=moderate persistent, 5=severe intermittent, and 6=severe persistent. | Baseline (Week 0); Weeks 1, 2, 4, 8, and 12 |
| Number of Participants in the Indicated Categories for Overall Tolerance at Week 12/Early Termination | Participants were evaluated for overall tolerance to study drug by the investigator at the end of the study (Week 12 or Early Termination). Participants were given the tolerance grades of poor, fair, good, or excellent. | Week 12 or Early Termination |
| Badalona |
| 08916 |
| Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital Universitario Ramón and Cajal | Madrid | 28034 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Clínico Universitario Ntra. Sra. de the Victoria | Málaga | 29010 | Spain |
| Clínica Universitaria de Navarra | Pamplona | 31008 | Spain |
| Hospital Clínico de Salamanca | Salamanca | 37007 | Spain |
| Protocol Violation |
|
| Adverse Event |
|
| Lost to Follow-up |
|
| Recovery |
|
| Missed Visit 2 Due to Personal Reasons |
|
Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| OG000 | Duac Gel | Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks |
| OG001 | Differin Gel | Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks |
|
|
|
| Secondary | Mean Change From Baseline to Week 12 for the Indicated Domain Scores and the Global Score of the Participant-completed Skindex-29 QoL Questionnaire | Skindex-29 is a self-administered QoL questionnaire comprised of 29 items scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 items), symptomatic (7 items), and functional (12 items), with domain scores ranging from 0 to 40, 28, and 48, respectively. Lower scores = better QoL. A Global Score (range 0-100) was derived by multiplying the sum of the points for all 29 items by a constant (0.862). Change from Baseline was calculated as the value at Week 2 minus the value at Baseline (Week 0). | ITT Population. Missing values were imputed using the LOCF method (i.e., the last available observation was used to estimate subsequent missing data points). One participant in the Differin arm had no QoL data available and was thus excluded from analysis. | Posted | Mean | Standard Deviation | scores on a scale | Baseline (Week 0) and Week 12 |
|
|
|
| Secondary | Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts | Lesions were counted on the entire face (defined as the area from the upper part of the jaw to the lower part of the hairline), excluding maculae and non-inflammatory lesions located on the nose or chin. Inflammatory lesions included papules, pustules, nodules, and cysts. Non-inflammatory lesions included closed comedones (whiteheads) and open comedones (blackheads). The total lesion count was calculated as the sum of inflammatory and non-inflammatory lesions. Change from Baseline was calculated as the values at Weeks 1, 2, 4, 8, and 12 minus the value at Baseline (Week 0). | ITT Population. Missing values were imputed using the LOCF method. | Posted | Mean | Standard Deviation | lesions | Baseline (Week 0) and Weeks 1, 2, 4, 8, and 12 |
|
|
|
| Secondary | Mean Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts | Lesions were counted on the entire face (defined as the area from the upper part of the jaw to the lower part of the hairline), excluding maculae and non-inflammatory lesions located on the nose or chin. Inflammatory lesions (IL) included papules, pustules, nodules, and cysts. Non-inflammatory lesions (NIL) included closed comedones (whiteheads) and open comedones (blackheads). Total lesion count was calculated as the sum of IL and NIL. Percent change from Baseline was calculated as the values at Weeks 1, 2, 4, 8, and 12 minus the value at Baseline divided by Baseline value * 100. | ITT Population. Missing values were imputed using the LOCF method. Some participants had no baseline lesions of an individual type; percent change from baseline is undefined for these participants. All participants, however, had at least one type of lesion; thus, all participants in the ITT Population were analyzed for total lesion count. | Posted | Mean | Standard Deviation | percent change in lesions | Baseline (Week 0) and Weeks 1, 2, 4, 8, and 12 |
|
|
|
| Secondary | Correlation Between Skindex-29 Questionnaire Scores and Total Lesion Counts From Baseline to Week 2 | Analyses were performed to determine whether there was a correlation between the total lesion count and either the global or subdomain Skindex-29 questionnaire scores. Correlations between the Skindex-29 questionnaire scores and total lesion count from Baseline to Week 2 were assessed using Spearman's correlation coefficients, which ranges from -1 to 1. A score of 0 denotes no correlation, a score approaching 1 denotes correlation, and a score approaching -1 denotes inverse correlation. | ITT Population. Missing values were imputed using the LOCF method. One participant in the Differin group had no data available and was thus excluded from analysis. | Posted | Number | Correlation coefficient | Baseline (Week 0) and Week 2 |
|
|
|
| Secondary | Mean Scores for Global Change in Acne Improvement at Weeks 1, 2, 4, 8, and 12 Compared to the Start of Treatment (Prior to Week 1) | Global change in acne improvement was assessed by the investigator on a 7-point scale: 1=greatly worsened, 2=significantly worsened, 3=slightly worsened, 4=no change, 5=slightly improved, 6=significantly improved, or 7=greatly improved. Global change at the indicated week was assessed in terms of change from the previous week. Change at Week 2, for example, was an assessment of change from Week 1. | ITT Population. Missing values were imputed using the LOCF method. Only those participants contributing data at the indicated time points were analyzed. | Posted | Mean | Standard Deviation | scores on a scale | Start of treatment and Weeks 1, 2, 4, 8, and 12 |
|
|
|
| Secondary | Mean Scores for Self-evaluation of Acne Improvement at Weeks 1, 2, 4, 8, and 12 Compared to the Start of Treatment (Prior to Week 1) | Participants self-evaluated their acne improvement on a 3-point scale: 1=worsened, 2=no changes, and 3=improved. | ITT Population. Missing values were imputed using the LOCF method. Only those participants contributing data at the indicated time points were analyzed. | Posted | Mean | Standard Deviation | scores on a scale | Start of treatment and Weeks 1, 2, 4, 8, and 12 |
|
|
|
| Secondary | Mean Acne Grades at Baseline and Weeks 1, 2, 4, 8, and 12 Assessed by the Leeds Revised Acne Grading System | The acne grade on the participant's face was assessed by the investigator using the LRAG, a photographic scale allowing for the assessment of the clinical status for acne severity for the face, back, and chest. It consists of a 12-grade scale (1, least severe; 12, most severe) for inflammatory visible lesions (les.). For non-inflammatory les., this scale comprises 3 photos of les. of increasing severity (grades 1-3). The scale provides a qualitative assessment of superficial/visible les. and provides consistency and inter-/intra-rater reliability. Grading was performed prior to les. counting. | ITT Population. Missing values were imputed using the LOCF method. | Posted | Mean | Standard Deviation | scores on a scale | Baseline (Week 0); Weeks 1, 2, 4, 8, and 12 |
|
|
|
| Secondary | Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness | Tolerance symptoms of peeling (flaking), erythema (redness of skin), and dryness were evaluated at each visit by the investigator. Possible scores were: 0=absent, 1=mild intermittent, 2=mild persistent, 3=moderate intermittent, 4=moderate persistent, 5=severe intermittent, and 6=severe persistent. | ITT Population. Missing values were imputed using the LOCF method (i.e., the last available observation was used to estimate subsequent missing data points). | Posted | Mean | Standard Deviation | scores on a scale | Baseline (Week 0); Weeks 1, 2, 4, 8, and 12 |
|
|
|
| Secondary | Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Itching and Burning | Tolerance symptoms of itching and burning were evaluated at each visit by participants. Possible scores were: 0=absent, 1=mild intermittent, 2=mild persistent, 3=moderate intermittent, 4=moderate persistent, 5=severe intermittent, and 6=severe persistent. | ITT Population. Missing values were imputed using the LOCF method (i.e., the last available observation was used to estimate subsequent missing data points). | Posted | Mean | Standard Deviation | scores on a scale | Baseline (Week 0); Weeks 1, 2, 4, 8, and 12 |
|
|
|
| Secondary | Number of Participants in the Indicated Categories for Overall Tolerance at Week 12/Early Termination | Participants were evaluated for overall tolerance to study drug by the investigator at the end of the study (Week 12 or Early Termination). Participants were given the tolerance grades of poor, fair, good, or excellent. | ITT Population. Some participants had no data available and were thus excluded from analysis. | Posted | Number | participants | Week 12 or Early Termination |
|
|
|
| 0 |
| 83 |
| 13 |
| 83 |
| EG001 | Differin Gel | Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks | 0 | 85 | 22 | 85 |
| Application Site Exfoliation | General disorders | MedDRA | Systematic Assessment |
|
| Application Site Pruritus | General disorders | MedDRA | Systematic Assessment |
|
| Application Site Dryness | General disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Application Site Irritation | General disorders | MedDRA | Systematic Assessment |
|
| Application Site Eczema | General disorders | MedDRA | Systematic Assessment |
|
| Application Site Dermatitis | General disorders | MedDRA | Systematic Assessment |
|
| Application Site Pain | General disorders | MedDRA | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pharyngotonsillitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Puncture Site Infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dysmenorrhea | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Ovarian Cyst | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Rectal Hemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
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.
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| Functional Domain |
|
| Global Score |
|
| Non-inflammatory Lesions, Week 4 |
|
| Non-inflammatory Lesions, Week 8 |
|
| Non-inflammatory Lesions, Week 12 |
|
| Inflammatory Lesions, Week 1 |
|
| Inflammatory Lesions, Week 2 |
|
| Inflammatory Lesions, Week 4 |
|
| Inflammatory Lesions, Week 8 |
|
| Inflammatory Lesions, Week 12 |
|
| Total Lesions, Week 1 |
|
| Total Lesions, Week 2 |
|
| Total Lesions, Week 4 |
|
| Total Lesions, Week 8 |
|
| Total Lesions, Week 12 |
|
| Non-inflammatory Lesions, Week 4, n=74, 73 |
|
| Non-inflammatory Lesions, Week 8, n=74, 73 |
|
| Non-inflammatory Lesions, Week 12, n=74, 73 |
|
| Inflammatory Lesions, Week 1, n=82, 84 |
|
| Inflammatory Lesions, Week 2, n=82, 84 |
|
| Inflammatory Lesions, Week 4, n=82, 84 |
|
| Inflammatory Lesions, Week 8, n=82, 84 |
|
| Inflammatory Lesions, Week 12, n=82, 84 |
|
| Total Lesions, Week 1, n=83, 85 |
|
| Total Lesions, Week 2, n=83, 85 |
|
| Total Lesions, Week 4, n=83, 85 |
|
| Total Lesions, Week 8, n=83, 85 |
|
| Total Lesions, Week 12, n=83, 85 |
|
| Emotional Domain |
|
| Global Score |
|
| Week 4, n=82, 83 |
|
| Week 8, n=82, 83 |
|
| Week 12, n=82, 84 |
|
| Week 4, n=82, 83 |
|
| Week 8, n=82, 83 |
|
| Week 12, n=82, 84 |
|
| Week 2 |
|
| Week 4 |
|
| Week 8 |
|
| Week 12 |
|
| Peeling, Week 4 |
|
| Peeling, Week 8 |
|
| Peeling, Week 12 |
|
| Erythema, Week 1 |
|
| Erythema, Week 2 |
|
| Erythema, Week 4 |
|
| Erythema, Week 8 |
|
| Erythema, Week 12 |
|
| Dryness, Week 1 |
|
| Dryness, Week 2 |
|
| Dryness, Week 4 |
|
| Dryness, Week 8 |
|
| Dryness, Week 12 |
|
| Itching, Week 4 |
|
| Itching, Week 8 |
|
| Itching, Week 12 |
|
| Burning, Week 1 |
|
| Burning, Week 2 |
|
| Burning, Week 4 |
|
| Burning, Week 8 |
|
| Burning, Week 12 |
|
| Good |
|
| Excellent |
|