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

• 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: Stiefel, a GSK Company
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Duac Gel	Differin Gel
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

Baseline Characteristics

Arm/Group Title		Duac Gel	Differin Gel	Total
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
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

Outcome Measures

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
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

Outcome Measure Data

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
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)

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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

Analysis Population Description

ITT Population. Missing values were imputed using the LOCF method.

Arm/Group Title	Duac Gel	Differin Gel
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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)
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

Outcome Measure Data

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
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)
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

Outcome Measure Data

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
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
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

Outcome Measure Data

Analysis Population Description

ITT Population. Missing values were imputed using the LOCF method.

Arm/Group Title	Duac Gel	Differin Gel
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

Analysis Population Description

ITT Population. Some participants had no data available and were thus excluded from analysis.

Arm/Group Title	Duac Gel	Differin Gel
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

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Duac Gel	Differin Gel
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	--/--	--/--
Serious Adverse Events
	Duac Gel	Differin Gel
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/83 (0.00%)	0/85 (0.00%)
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

Limitations and Caveats

[Not Specified]

More Information

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
• 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