Back to resultsEvaluation of Quality of Life, Efficacy, and Tolerance of Duac® Gel Compared to Differin® Gel in the Treatment of Acne
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Duac Gel
Differin gel
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris focused on measuring Differin, quality of life, Acne, Duac, Acne Vulgaris
Eligibility Criteria
Inclusion Criteria:
- Subjects with mild to moderate acne vulgaris on the face,.
- Subjects of either sex aged between 12 and 39 years, inclusive.
- Subjects agreeing not to use sun-beds or undergo any UV light treatment for 4 weeks prior to entering the study and to minimize the amount of exposure to direct sunlight for the duration of the study.
Exclusion Criteria:
- Women who are pregnant, breast-feeding, or sexually active with the potential to have children, and not using a contraception method that is safe from a medical point of view
- Subjects using anti-androgen containing contraceptives.
- Subjects who, during the past month, have received oral or topical steroids or antibiotics, or acne treatment of any type, including natural or artificial UV therapy.
- Subjects who have a history of hypersensitivity or idiosyncratic reaction to clindamycin phosphate, benzoyl peroxide, adapalene or any components of the medicinal products which will be used during the study.
- Subjects using, or having used in the past month, any significant concomitant medicinal product which might affect their acne, as judged by the Investigator.
- Subjects with a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.
- Subjects with a history of photosensitivity.
Sites / Locations
- Hospital Germans Trias I Pujol
- Hospital del Mar
- Hospital Abente y Lago in La Coruna
- Hospital Universitario Ramón and Cajal
- Hospital Universitario 12 de Octubre
- Hospital Clínico Universitario Ntra. Sra. de the Victoria
- Clínica Universitaria de Navarra
- Hospital Clínico de Salamanca
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Duac Gel
Differin gel
Arm Description
Duac Gel
Differin gel
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT00807014
First Posted
December 10, 2008
Last Updated
March 15, 2012
Sponsor
Stiefel, a GSK Company
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00807014
Brief Title
Evaluation of Quality of Life, Efficacy, and Tolerance of Duac® Gel Compared to Differin® Gel in the Treatment of Acne
Official Title
Single-blind, Multicenter, Parallel, Comparative, Randomized, Phase 4 Clinical Trial for the Evaluation of the Quality of Life, Efficacy and Tolerance of Duac® Gel Against Differin® Gel in the Topical Treatment of Mild to Moderate Acne Vulgaris.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stiefel, a GSK Company
Collaborators
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Differin, quality of life, Acne, Duac, Acne Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
169 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Duac Gel
Arm Type
Experimental
Arm Description
Duac Gel
Arm Title
Differin gel
Arm Type
Active Comparator
Arm Description
Differin gel
Intervention Type
Drug
Intervention Name(s)
Duac Gel
Other Intervention Name(s)
Duac
Intervention Description
Duac® Gel will be applied to the face once daily at night, for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Differin gel
Other Intervention Name(s)
Differin
Intervention Description
Differin Gel will be applied to the face once daily at night, for 12 weeks.
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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
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
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
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
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
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
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
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
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with mild to moderate acne vulgaris on the face,.
Subjects of either sex aged between 12 and 39 years, inclusive.
Subjects agreeing not to use sun-beds or undergo any UV light treatment for 4 weeks prior to entering the study and to minimize the amount of exposure to direct sunlight for the duration of the study.
Exclusion Criteria:
Women who are pregnant, breast-feeding, or sexually active with the potential to have children, and not using a contraception method that is safe from a medical point of view
Subjects using anti-androgen containing contraceptives.
Subjects who, during the past month, have received oral or topical steroids or antibiotics, or acne treatment of any type, including natural or artificial UV therapy.
Subjects who have a history of hypersensitivity or idiosyncratic reaction to clindamycin phosphate, benzoyl peroxide, adapalene or any components of the medicinal products which will be used during the study.
Subjects using, or having used in the past month, any significant concomitant medicinal product which might affect their acne, as judged by the Investigator.
Subjects with a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.
Subjects with a history of photosensitivity.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Germans Trias I Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Abente y Lago in La Coruna
City
La Coruna
Country
Spain
Facility Name
Hospital Universitario Ramón and Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Clínico Universitario Ntra. Sra. de the Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Clínica Universitaria de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Clínico de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Quality of Life, Efficacy, and Tolerance of Duac® Gel Compared to Differin® Gel in the Treatment of Acne
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