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Evaluation of Quality of Life, Efficacy, and Tolerance of Duac® Gel Compared to Differin® Gel in the Treatment of Acne

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ClinicalTrials.gov Identifier: NCT00807014
Recruitment Status : Completed
First Posted : December 11, 2008
Results First Posted : March 6, 2012
Last Update Posted : March 20, 2012
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: Duac Gel
Drug: Differin gel
Enrollment 169
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Duac Gel Differin Gel
Hide Arm/Group Description Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
Period Title: Overall Study
Started 83 85
Completed 56 58
Not Completed 27 27
Reason Not Completed
Participant Considered Disease Cured             13             2
Participant Considered Disease Not Cured             2             7
Protocol Violation             2             8
Adverse Event             0             2
Lost to Follow-up             9             7
Recovery             1             0
Missed Visit 2 Due to Personal Reasons             0             1
Arm/Group Title Duac Gel Differin Gel Total
Hide Arm/Group Description Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 83 85 168
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 83 participants 85 participants 168 participants
18.9  (5.3) 19.2  (5.3) 19.1  (5.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 85 participants 168 participants
Female
59
  71.1%
65
  76.5%
124
  73.8%
Male
24
  28.9%
20
  23.5%
44
  26.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 83 participants 85 participants 168 participants
Caucasian 75 77 152
Asian 2 1 3
Black 1 0 1
Mixed or Multiracial 2 3 5
Captured as "Other" on Case Report Form 3 4 7
1.Primary Outcome
Title Mean Change From Baseline to Week 2 in the Global Score of the Participant-completed Skindex-29 Quality of Life (QoL) Questionnaire
Hide Description 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).
Time Frame Baseline (Week 0) and Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Duac Gel Differin Gel
Hide Arm/Group Description:
Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
Overall Number of Participants Analyzed 83 84
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-4.9  (7.2) -1.1  (8.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duac Gel, Differin Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Analysis of covariance (ANCOVA) model was used with terms for baseline value, treatment, and center. Treatment-by-center interaction was not included.
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Mean Change From Baseline to Week 12 for the Indicated Domain Scores and the Global Score of the Participant-completed Skindex-29 QoL Questionnaire
Hide Description 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).
Time Frame Baseline (Week 0) and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Duac Gel Differin Gel
Hide Arm/Group Description:
Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
Overall Number of Participants Analyzed 83 84
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Symptomatic Domain -7.4  (13.0) -2.8  (16.7)
Emotional Domain -10.3  (15.1) -5.4  (13.5)
Functional Domain -3.5  (7.6) -0.1  (8.0)
Global Score -6.8  (9.1) -2.6  (9.8)
3.Secondary Outcome
Title Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts
Hide Description 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).
Time Frame Baseline (Week 0) and Weeks 1, 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Missing values were imputed using the LOCF method.
Arm/Group Title Duac Gel Differin Gel
Hide Arm/Group Description:
Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
Overall Number of Participants Analyzed 83 85
Mean (Standard Deviation)
Unit of Measure: lesions
Non-inflammatory Lesions, Week 1 -8.5  (12.8) -6.3  (15.6)
Non-inflammatory Lesions, Week 2 -11.8  (17.3) -8.2  (17.9)
Non-inflammatory Lesions, Week 4 -16.3  (20.2) -9.1  (16.8)
Non-inflammatory Lesions, Week 8 -18.4  (21.7) -8.4  (30.7)
Non-inflammatory Lesions, Week 12 -22.6  (23.0) -12.6  (33.3)
Inflammatory Lesions, Week 1 -10.1  (12.5) -5.4  (8.9)
Inflammatory Lesions, Week 2 -13.0  (13.2) -8.5  (11.1)
Inflammatory Lesions, Week 4 -16.6  (14.4) -9.6  (11.7)
Inflammatory Lesions, Week 8 -17.5  (16.1) -8.7  (14.4)
Inflammatory Lesions, Week 12 -18.8  (17.8) -11.2  (15.5)
Total Lesions, Week 1 -18.6  (18.1) -11.7  (19.1)
Total Lesions, Week 2 -24.8  (21.0) -16.8  (23.7)
Total Lesions, Week 4 -32.9  (25.2) -18.8  (21.1)
Total Lesions, Week 8 -35.9  (29.0) -17.1  (36.8)
Total Lesions, Week 12 -41.4  (32.3) -23.8  (40.5)
4.Secondary Outcome
Title Mean Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts
Hide Description 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.
Time Frame Baseline (Week 0) and Weeks 1, 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Duac Gel Differin Gel
Hide Arm/Group Description:
Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
Overall Number of Participants Analyzed 83 85
Mean (Standard Deviation)
Unit of Measure: percent change in lesions
Non-inflammatory Lesions, Week 1, n=74, 73 -29.8  (36.3) -22.9  (52.8)
Non-inflammatory Lesions, Week 2, n=74, 73 -38.4  (60.1) -26.5  (79.5)
Non-inflammatory Lesions, Week 4, n=74, 73 -52.6  (50.7) -36.4  (62.1)
Non-inflammatory Lesions, Week 8, n=74, 73 -59.5  (44.1) -32.8  (68.9)
Non-inflammatory Lesions, Week 12, n=74, 73 -69.7  (36.4) -45.5  (69.3)
Inflammatory Lesions, Week 1, n=82, 84 -36.8  (32.1) -21.0  (45.1)
Inflammatory Lesions, Week 2, n=82, 84 -53.0  (32.7) -36.4  (48.2)
Inflammatory Lesions, Week 4, n=82, 84 -67.9  (27.7) -38.3  (50.6)
Inflammatory Lesions, Week 8, n=82, 84 -67.6  (31.4) -33.8  (61.2)
Inflammatory Lesions, Week 12, n=82, 84 -72.4  (34.7) -46.5  (58.5)
Total Lesions, Week 1, n=83, 85 -32.1  (28.6) -22.6  (34.8)
Total Lesions, Week 2, n=83, 85 -46.3  (31.0) -33.6  (42.6)
Total Lesions, Week 4, n=83, 85 -59.6  (30.8) -38.5  (40.7)
Total Lesions, Week 8, n=83, 85 -65.7  (30.8) -35.2  (54.0)
Total Lesions, Week 12, n=83, 85 -73.0  (26.7) -47.7  (53.2)
5.Secondary Outcome
Title Correlation Between Skindex-29 Questionnaire Scores and Total Lesion Counts From Baseline to Week 2
Hide Description 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.
Time Frame Baseline (Week 0) and Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Duac Gel Differin Gel
Hide Arm/Group Description:
Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
Overall Number of Participants Analyzed 83 84
Measure Type: Number
Unit of Measure: Correlation coefficient
Functional Domain 0.042 -0.094
Symptomatic Domain 0.166 0.002
Emotional Domain 0.237 -0.137
Global Score 0.223 -0.087
6.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame Start of treatment and Weeks 1, 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Missing values were imputed using the LOCF method. Only those participants contributing data at the indicated time points were analyzed.
Arm/Group Title Duac Gel Differin Gel
Hide Arm/Group Description:
Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
Overall Number of Participants Analyzed 82 84
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1, n=82, 82 5.2  (1.0) 4.9  (0.9)
Week 2, n=82, 83 5.4  (1.0) 5.3  (0.9)
Week 4, n=82, 83 5.7  (1.2) 5.3  (1.1)
Week 8, n=82, 83 5.8  (1.3) 5.1  (1.4)
Week 12, n=82, 84 6.0  (1.2) 5.5  (1.3)
7.Secondary Outcome
Title 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)
Hide Description Participants self-evaluated their acne improvement on a 3-point scale: 1=worsened, 2=no changes, and 3=improved.
Time Frame Start of treatment and Weeks 1, 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Missing values were imputed using the LOCF method. Only those participants contributing data at the indicated time points were analyzed.
Arm/Group Title Duac Gel Differin Gel
Hide Arm/Group Description:
Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
Overall Number of Participants Analyzed 82 84
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1, n=82, 82 2.8  (0.5) 2.5  (0.7)
Week 2, n=82, 83 2.8  (0.5) 2.7  (0.6)
Week 4, n=82, 83 2.7  (0.6) 2.7  (0.6)
Week 8, n=82, 83 2.8  (0.5) 2.5  (0.7)
Week 12, n=82, 84 2.8  (0.5) 2.6  (0.7)
8.Secondary Outcome
Title Mean Acne Grades at Baseline and Weeks 1, 2, 4, 8, and 12 Assessed by the Leeds Revised Acne Grading System
Hide Description 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.
Time Frame Baseline (Week 0); Weeks 1, 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Missing values were imputed using the LOCF method.
Arm/Group Title Duac Gel Differin Gel
Hide Arm/Group Description:
Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
Overall Number of Participants Analyzed 83 85
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline (Week 0) 2.7  (0.9) 2.6  (0.8)
Week 1 2.4  (0.9) 2.3  (0.8)
Week 2 2.0  (0.8) 2.1  (0.9)
Week 4 1.7  (0.9) 1.9  (0.8)
Week 8 1.6  (0.9) 1.9  (0.9)
Week 12 1.2  (0.9) 1.6  (1.0)
9.Secondary Outcome
Title Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness
Hide Description 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.
Time Frame Baseline (Week 0); Weeks 1, 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Missing values were imputed using the LOCF method (i.e., the last available observation was used to estimate subsequent missing data points).
Arm/Group Title Duac Gel Differin Gel
Hide Arm/Group Description:
Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
Overall Number of Participants Analyzed 83 85
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Peeling, Week 1 0.5  (0.8) 0.8  (1.0)
Peeling, Week 2 0.2  (0.5) 0.6  (1.1)
Peeling, Week 4 0.3  (0.6) 0.6  (1.0)
Peeling, Week 8 0.1  (0.4) 0.5  (0.9)
Peeling, Week 12 0.1  (0.3) 0.4  (0.8)
Erythema, Week 1 0.6  (1.0) 0.8  (1.1)
Erythema, Week 2 0.3  (0.8) 0.9  (1.2)
Erythema, Week 4 0.3  (0.6) 0.7  (1.0)
Erythema, Week 8 0.3  (0.6) 0.6  (1.0)
Erythema, Week 12 0.2  (0.5) 0.4  (0.9)
Dryness, Week 1 0.6  (1.1) 0.8  (1.0)
Dryness, Week 2 0.4  (0.8) 0.8  (1.2)
Dryness, Week 4 0.3  (0.6) 0.7  (1.0)
Dryness, Week 8 0.2  (0.5) 0.6  (1.1)
Dryness, Week 12 0.1  (0.4) 0.4  (0.9)
10.Secondary Outcome
Title Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Itching and Burning
Hide Description 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.
Time Frame Baseline (Week 0); Weeks 1, 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Missing values were imputed using the LOCF method (i.e., the last available observation was used to estimate subsequent missing data points).
Arm/Group Title Duac Gel Differin Gel
Hide Arm/Group Description:
Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
Overall Number of Participants Analyzed 83 85
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Itching, Week 1 0.4  (0.8) 0.9  (1.3)
Itching, Week 2 0.2  (0.6) 0.7  (1.0)
Itching, Week 4 0.2  (0.5) 0.7  (1.2)
Itching, Week 8 0.1  (0.4) 0.6  (1.2)
Itching, Week 12 0.1  (0.3) 0.5  (1.1)
Burning, Week 1 0.3  (0.7) 0.9  (1.3)
Burning, Week 2 0.1  (0.4) 0.6  (1.1)
Burning, Week 4 0.1  (0.4) 0.5  (1.2)
Burning, Week 8 0.1  (0.2) 0.6  (1.2)
Burning, Week 12 0.0  (0.2) 0.5  (1.1)
11.Secondary Outcome
Title Number of Participants in the Indicated Categories for Overall Tolerance at Week 12/Early Termination
Hide Description 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.
Time Frame Week 12 or Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Some participants had no data available and were thus excluded from analysis.
Arm/Group Title Duac Gel Differin Gel
Hide Arm/Group Description:
Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
Overall Number of Participants Analyzed 80 83
Measure Type: Number
Unit of Measure: participants
Poor 0 5
Fair 4 14
Good 42 47
Excellent 34 17
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Duac Gel Differin Gel
Hide Arm/Group Description Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
All-Cause Mortality
Duac Gel Differin Gel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Duac Gel Differin Gel
Affected / at Risk (%) Affected / at Risk (%)
Total   0/83 (0.00%)   0/85 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Duac Gel Differin Gel
Affected / at Risk (%) Affected / at Risk (%)
Total   13/83 (15.66%)   22/85 (25.88%) 
Blood and lymphatic system disorders     
Lymphadenopathy  1  0/83 (0.00%)  1/85 (1.18%) 
Gastrointestinal disorders     
Rectal Hemorrhage  1  1/83 (1.20%)  0/85 (0.00%) 
Hemorrhoids  1  0/83 (0.00%)  1/85 (1.18%) 
General disorders     
Application Site Erythema  1  2/83 (2.41%)  5/85 (5.88%) 
Application Site Exfoliation  1  2/83 (2.41%)  4/85 (4.71%) 
Application Site Pruritus  1  2/83 (2.41%)  4/85 (4.71%) 
Application Site Dryness  1  1/83 (1.20%)  2/85 (2.35%) 
Pyrexia  1  1/83 (1.20%)  0/85 (0.00%) 
Application Site Irritation  1  0/83 (0.00%)  5/85 (5.88%) 
Application Site Eczema  1  0/83 (0.00%)  4/85 (4.71%) 
Application Site Dermatitis  1  0/83 (0.00%)  2/85 (2.35%) 
Application Site Pain  1  0/83 (0.00%)  1/85 (1.18%) 
Infections and infestations     
Nasopharyngitis  1  3/83 (3.61%)  2/85 (2.35%) 
Upper Respiratory Tract Infection  1  1/83 (1.20%)  1/85 (1.18%) 
Pharyngotonsillitis  1  1/83 (1.20%)  0/85 (0.00%) 
Tonsillitis  1  0/83 (0.00%)  2/85 (2.35%) 
Cystitis  1  0/83 (0.00%)  1/85 (1.18%) 
Infection  1  0/83 (0.00%)  1/85 (1.18%) 
Puncture Site Infection  1  0/83 (0.00%)  1/85 (1.18%) 
Musculoskeletal and connective tissue disorders     
Periarthritis  1  0/83 (0.00%)  1/85 (1.18%) 
Nervous system disorders     
Headache  1  3/83 (3.61%)  0/85 (0.00%) 
Psychiatric disorders     
Anxiety  1  1/83 (1.20%)  0/85 (0.00%) 
Reproductive system and breast disorders     
Dysmenorrhea  1  1/83 (1.20%)  1/85 (1.18%) 
Ovarian Cyst  1  1/83 (1.20%)  0/85 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Rhinitis Allergic  1  0/83 (0.00%)  1/85 (1.18%) 
Skin and subcutaneous tissue disorders     
Dermatitis  1  0/83 (0.00%)  1/85 (1.18%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT00807014     History of Changes
Other Study ID Numbers: 114567
S194-SP-05/Duac
First Submitted: December 10, 2008
First Posted: December 11, 2008
Results First Submitted: November 23, 2011
Results First Posted: March 6, 2012
Last Update Posted: March 20, 2012