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

This study has been completed.

Sponsor:

Collaborator:

GlaxoSmithKline

Information provided by (Responsible Party):

GlaxoSmithKline ( Stiefel, a GSK Company )

ClinicalTrials.gov Identifier:

NCT00807014

First received: December 10, 2008

Last updated: March 15, 2012

Last verified: February 2012

History of Changes

Results First Received: November 23, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Investigator); Primary Purpose: Treatment
Condition:	Acne Vulgaris
Interventions:	Drug: Duac Gel Drug: Differin gel

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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
Differin Gel	Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks

Participant Flow: Overall Study

	Duac Gel	Differin Gel
STARTED	83	85
COMPLETED	56	58
NOT COMPLETED	27	27
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

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Reporting Groups

	Description
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
Differin Gel	Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
Total	Total of all reporting groups

Baseline Measures

	Duac Gel	Differin Gel	Total
Number of Participants [units: participants]	83	85	168
Age [units: Years] Mean ± Standard Deviation	18.9 ± 5.3	19.2 ± 5.3	19.1 ± 5.3
Gender [units: Participants]
Female	59	65	124
Male	24	20	44
Race/Ethnicity, Customized [units: 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

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1. Primary:

Mean Change From Baseline to Week 2 in the Global Score of the Participant-completed Skindex-29 Quality of Life (QoL) Questionnaire [ Time Frame: Baseline (Week 0) and Week 2 ]

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2. 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 [ Time Frame: Baseline (Week 0) and Week 12 ]

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3. Secondary:

Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts [ Time Frame: Baseline (Week 0) and Weeks 1, 2, 4, 8, and 12 ]

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4. Secondary:

Mean Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts [ Time Frame: Baseline (Week 0) and Weeks 1, 2, 4, 8, and 12 ]

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5. Secondary:

Correlation Between Skindex-29 Questionnaire Scores and Total Lesion Counts From Baseline to Week 2 [ Time Frame: Baseline (Week 0) and Week 2 ]

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6. 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) [ Time Frame: Start of treatment and Weeks 1, 2, 4, 8, and 12 ]

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7. 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) [ Time Frame: Start of treatment and Weeks 1, 2, 4, 8, and 12 ]

Show Outcome Measure 7

8. Secondary:

Mean Acne Grades at Baseline and Weeks 1, 2, 4, 8, and 12 Assessed by the Leeds Revised Acne Grading System [ Time Frame: Baseline (Week 0); Weeks 1, 2, 4, 8, and 12 ]

Show Outcome Measure 8

9. Secondary:

Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness [ Time Frame: Baseline (Week 0); Weeks 1, 2, 4, 8, and 12 ]

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Measure Type	Secondary
Measure Title	Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT Population. Missing values were imputed using the LOCF method (i.e., the last available observation was used to estimate subsequent missing data points).

Reporting Groups

	Description
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
Differin Gel	Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks

Measured Values

	Duac Gel	Differin Gel
Number of Participants Analyzed [units: participants]	83	85
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness [units: scores on a scale] Mean ± Standard Deviation
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

No statistical analysis provided for Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness

10. Secondary:

Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Itching and Burning [ Time Frame: Baseline (Week 0); Weeks 1, 2, 4, 8, and 12 ]

Show Outcome Measure 10

11. Secondary:

Number of Participants in the Indicated Categories for Overall Tolerance at Week 12/Early Termination [ Time Frame: Week 12 or Early Termination ]

Show Outcome Measure 11

Serious Adverse Events

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Other Adverse Events

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More Information

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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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

Responsible Party:	GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier:	NCT00807014 History of Changes
Other Study ID Numbers:	114567, S194-SP-05/Duac
Study First Received:	December 10, 2008
Results First Received:	November 23, 2011
Last Updated:	March 15, 2012
Health Authority:	Spain: Comité Ético de Investigación Clínica

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