Acne Vulgaris
Conditions
Keywords
Acne vulgaris
Brief summary
Multi-center, single-blind, randomized, comparative, split-face study. The duration of the study is 8 weeks. Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide gel and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Detailed description
Multi-center, single-blind, randomized, comparative, split-face study. The duration of the study is 8 weeks and consists of a baseline visit and visits at weeks 1, 2, 5 and 8. Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide gel and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3 subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks. Blinding This is an investigator-blinded study; therefore, subjects and study-center staff will not be blinded to study treatment allocation (ie, left vs. right side application). During the first 2 weeks, the investigator will be unaware of which study product is being used on either side of the face. Subjects and study-center staff will be instructed not to reveal study treatment allocation to the investigator. Subjects will be instructed not to use study product in the presence of the investigator.
Interventions
DRUGClindamycin and benzoyl peroxide gel (Duac® Topical Gel)
Subjects will apply Duac(clindamycin and benzoyl peroxide) gel to one-half of their face and and apply Epiduo (benzoyl peroxide/adapalene) gel on the other side of their face once a day for the first 2 weeks. Starting at week 2, subjects will apply Duac (benzoyl peroxide/clindamycin gel) to the entire face for an additional 6 weeks.
DRUGbenzoyl peroxide and adapalene gel (EPIDUO™ Gel)
Subjects will apply Duac(clindamycin and benzoyl peroxide) gel to one-half of their face and and apply Epiduo (benzoyl peroxide/adapalene) gel on the other side of their face once a day for the first 2 weeks. Starting at week 2, subjects will apply Duac (benzoyl peroxide/clindamycin gel) to the entire face for an additional 6 weeks.
Sponsors
GlaxoSmithKline
Stiefel, a GSK Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female subjects at least 18 years of age, in good general health with documented diagnosis of facial acne vulgaris. * Sexually active females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product. * Subjects willing to follow therapeutic instructions including avoidance of any other topical facial or systemic acne therapy during the conduct of the study. * Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific procedures are performed.
Exclusion criteria
* Female subjects who are pregnant, trying to become pregnant or breastfeeding. * Subjects who have any clinically relevant finding at their baseline physical examination or medical history such as severe systemic diseases, diseases of the facial skin, other than acne vulgaris. * Facial hair that may obscure the accurate assessment of acne grade. * History or presence of regional enteritis or inflammatory bowel disease (e.g., ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-associated colitis) or similar symptoms. * Use of topical antibiotics on the face and systemic antibiotics within the past 2 and 4 weeks, respectively. * Use of topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra-articular or intra-lesional (other than for facial acne lesions) steroids is acceptable. * Use of systemic retinoids within the past 6 months. * Concurrent use of drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of increased phototoxicity. * Concomitant use of neuromuscular blocking agents. Clindamycin has neuromuscular blocking activities, which may enhance the action of other neuromuscular blocking agents. * Use of topical anti-acne medications within the past 2 weeks. * Use of any investigational drugs or treatments during the study or within 4 weeks of the baseline visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin Dryness Score | Week 1, Week 2 | Investigator assessment of tolerability (skin dryness) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. |
| Skin Peeling Score | Week 1, Week 2 | Investigator assessment of tolerability (skin peeling) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; Intense, 3. |
| Irritant/Allergic Contact Dermatitis Score | Week 1, Week 2 | Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis) on the face. Erythema,peeling, and dryness were graded using the following scale: 0 None 1. Slight 2. Moderate 3. Intense |
| Erythema (Redness) Score | Week 1, Week 2 | Investigator assessment of tolerability (irritant/allergic contact dermatitis) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Static Global Assessment Score | Week 5, Week 8 | ISGA is evaluated using the following scale: 0, clear, clear skin with no lesions; 1, almost clear, rare non-inflammatory lesions; 2, mild, some non-inflammatory lesions with no more than a few inflammatory lesions but no nodular lesions; 3, moderate, up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 small nodular lesion; 4, severe, up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions; 5, very severe, many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions. |
| Inflammatory Acne Lesion Counts | Week 5, Week 8 | Total number of inflammatory acne lesions (pustules, papules) at each timepoint. |
| Non-Inflammatory Acne Lesion Counts | Week 5, Week 8 | Total number of non-inflammatory acne lesions (whiteheads and blackheads) at each timepoint. |
| Total Acne Lesion Counts | Week 5, Week 8 | Total acne lesion counts - includes both inflammatory acne lesions (pustules, papules), noninflammatory lesions (whiteheads and blackheads), |
| Skindex-29 Quality of Life Questionnaire - Symptomatic Domain | Baseline, and Week 8 | Skindex-29 Quality of Life (QoL) Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: never to all the time, higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain. |
| Skindex-29 Quality of Life Questionnaire - Emotional Domain | Baseline, and Week 8 | Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: never to all the time, higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain. |
| Skindex-29 Quality of Life Questionnaire - Functional Domain | Baseline, and Week 8 | Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: never to all the time, higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain. |
| Skindex-29 Quality of Life Questionnaire - Global Score | Baseline, and Week 8 | Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: never to all the time, higher scores for each domain indicate worse effects on QoL. The Global Score ranges from 0 to 100. Higher scores indicate worse QoL for that domain. |
| Product Acceptability and Preference Questionnaire - Severity of Redness | Week 1, Week 2 | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. |
| Product Acceptability and Preference Questionnaire - Severity of Dryness | Week 1, Week 2 | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. |
| Product Acceptability and Preference Questionnaire - Severity of Burning | Week 1, Week 2 | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. |
| Erythema (Redness) Score | Week 5, Week 8 | Investigator assessment of tolerability (erythema) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. |
| Product Acceptability and Preference Questionnaire - Severity of Scaling | Week 1, Week 2 | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. |
| Product Acceptability and Preference Questionnaire - Ease of Application of Product | Week 1, Week 2 | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very easy; 2, easy; 3, neutral; 4, difficult; 5, very difficult. |
| Product Acceptability and Preference Questionnaire - Comfort of Skin | Week 1, Week 2 | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very comfortable; 2, comfortable; 3, somewhat comfortable; 4, somewhat uncomfortable; 5, uncomfortable. |
| Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With? | Week 1, Week 2 | Product Acceptability and Preference Questionnaire was completed by the subject at week 1 and week 2 asking which study product they were more satisfied with: Duac or Epiduo. |
| Product Acceptability and Preference Questionnaire - Comparison of Study Products to Products Used in the Past | Week 8 | Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, more satisfied; 2, somewhat more satisfied; 3, neither satisfied or dissatisfied; 4, more satisfied; 5, more dissatisfied. |
| Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products | Week 1, Week 2 | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, highly favorable; 2, favorable; 3, neutral; 4, unfavorable; 5, highly unfavorable. |
| Product Acceptability and Preference Questionnaire - Compliance | Week 1, Week 2 | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, non-compliant (\< 50% of the week); 1, mostly compliant (50-79%); 2, very compliant (80-100%). |
| Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin | Week 1, Week 2 | Subject response to question: did you feel that your skin was hydrated and moisturized while you on your study product? (Yes or No). |
| Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment | Week 1, Week 2 | Subject response to the following question: If you were to choose to continue treatment for your acne, which treatment would you choose? (Yes or No). |
| Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up | Week 1, Week 2 | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, not applicable; 1, very easy; 2, easy; 3, neutral; 4, difficult. |
| Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product | Week 1, Week 2 | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very satisfied; 2, satisfied; 3, neutral; 4, unsatisfied; 5, very unsatisfied. |
| Product Acceptability and Preference Questionnaire - Severity of Itching | Week 1, Week 2 | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. |
| Skin Dryness Score | Week 5, Week 8 | Investigator assessment of tolerability (skin dryness) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. |
| Skin Peeling Score | Week 5, Week 8 | Investigator assessment of tolerability (skin peeling) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. |
| Irritant/Allergic Contact Dermatitis Score | Week 5, Week 8 | Investigator assessment of tolerability (contact dermatitis) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. |
Countries
United States
Participant flow
Recruitment details
Clinical research centers
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks. | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Full Face Treatment (Weeks 5 and 8) | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 29.6 years STANDARD_DEVIATION 9.5 |
| Inflammatory Acne Lesion Count | 21.5 Inflammatory Lesion STANDARD_DEVIATION 9.3 |
| Investigators Static Global Assessment (ISGA) Mild | 2 Participants |
| Investigators Static Global Assessment (ISGA) Moderate | 20 Participants |
| Investigators Static Global Assessment (ISGA) Severe | 6 Participants |
| Non-Inflammatory Acne Lesion Count | 33.0 Non-Inflammatory lesion STANDARD_DEVIATION 24.7 |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 11 Participants |
| Race/Ethnicity, Customized White | 15 Participants |
| Region of Enrollment United States | 28 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 4 Participants |
| Total Acne Lesion Count | 54.5 Acne lesions STANDARD_DEVIATION 27.1 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
Primary
Erythema (Redness) Score
Investigator assessment of tolerability (irritant/allergic contact dermatitis) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Time frame: Week 1, Week 2
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac Gel | Erythema (Redness) Score | Week 1 | 0.27 Units on a scale | Standard Deviation 0.53 |
| Duac Gel | Erythema (Redness) Score | Week 2 | 0.18 Units on a scale | Standard Deviation 0.39 |
| Epiduo Gel | Erythema (Redness) Score | Week 1 | 0.58 Units on a scale | Standard Deviation 0.81 |
| Epiduo Gel | Erythema (Redness) Score | Week 2 | 0.36 Units on a scale | Standard Deviation 0.49 |
Primary
Irritant/Allergic Contact Dermatitis Score
Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis) on the face. Erythema,peeling, and dryness were graded using the following scale: 0 None 1. Slight 2. Moderate 3. Intense
Time frame: Week 1, Week 2
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac Gel | Irritant/Allergic Contact Dermatitis Score | Week 1 | 0.00 Units on a scale | Standard Deviation 0 |
| Duac Gel | Irritant/Allergic Contact Dermatitis Score | Week 2 | 0.00 Units on a scale | Standard Deviation 0 |
| Epiduo Gel | Irritant/Allergic Contact Dermatitis Score | Week 1 | 0.15 Units on a scale | Standard Deviation 0.46 |
| Epiduo Gel | Irritant/Allergic Contact Dermatitis Score | Week 2 | 0.00 Units on a scale | Standard Deviation 0 |
Primary
Skin Dryness Score
Investigator assessment of tolerability (skin dryness) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Time frame: Week 1, Week 2
Population: Intent-to-Treat (ITT) Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac Gel | Skin Dryness Score | Week 1 | 0.15 Units on a scale | Standard Deviation 0.37 |
| Duac Gel | Skin Dryness Score | Week 2 | 0.14 Units on a scale | Standard Deviation 0.36 |
| Epiduo Gel | Skin Dryness Score | Week 1 | 0.46 Units on a scale | Standard Deviation 0.71 |
| Epiduo Gel | Skin Dryness Score | Week 2 | 0.29 Units on a scale | Standard Deviation 0.53 |
Primary
Skin Peeling Score
Investigator assessment of tolerability (skin peeling) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; Intense, 3.
Time frame: Week 1, Week 2
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac Gel | Skin Peeling Score | Week 2 | 0.18 Units on a scale | Standard Deviation 0.39 |
| Duac Gel | Skin Peeling Score | Week 1 | 0.15 Units on a scale | Standard Deviation 0.37 |
| Epiduo Gel | Skin Peeling Score | Week 1 | 0.54 Units on a scale | Standard Deviation 0.71 |
| Epiduo Gel | Skin Peeling Score | Week 2 | 0.21 Units on a scale | Standard Deviation 0.5 |
Secondary
Erythema (Redness) Score
Investigator assessment of tolerability (erythema) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Time frame: Week 5, Week 8
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac Gel | Erythema (Redness) Score | Week 5 | 0.26 Units on a scale | Standard Deviation 0.53 |
| Duac Gel | Erythema (Redness) Score | Week 8 | 0.19 Units on a scale | Standard Deviation 0.4 |
Secondary
Inflammatory Acne Lesion Counts
Total number of inflammatory acne lesions (pustules, papules) at each timepoint.
Time frame: Week 5, Week 8
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac Gel | Inflammatory Acne Lesion Counts | Week 5 | 8.44 inflammatory acne lesions | Standard Deviation 7.57 |
| Duac Gel | Inflammatory Acne Lesion Counts | Week 8 | 7.00 inflammatory acne lesions | Standard Deviation 9.03 |
Secondary
Investigator Static Global Assessment Score
ISGA is evaluated using the following scale: 0, clear, clear skin with no lesions; 1, almost clear, rare non-inflammatory lesions; 2, mild, some non-inflammatory lesions with no more than a few inflammatory lesions but no nodular lesions; 3, moderate, up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 small nodular lesion; 4, severe, up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions; 5, very severe, many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions.
Time frame: Week 5, Week 8
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac Gel | Investigator Static Global Assessment Score | Week 5 | 2.63 Units on a scale | Standard Deviation 0.93 |
| Duac Gel | Investigator Static Global Assessment Score | Week 8 | 2.15 Units on a scale | Standard Deviation 1.03 |
Secondary
Irritant/Allergic Contact Dermatitis Score
Investigator assessment of tolerability (contact dermatitis) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Time frame: Week 5, Week 8
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac Gel | Irritant/Allergic Contact Dermatitis Score | Week 5 | 0.04 Units on a scale | Standard Deviation 0.19 |
| Duac Gel | Irritant/Allergic Contact Dermatitis Score | Week 8 | 0.00 Units on a scale | Standard Deviation 0 |
Secondary
Non-Inflammatory Acne Lesion Counts
Total number of non-inflammatory acne lesions (whiteheads and blackheads) at each timepoint.
Time frame: Week 5, Week 8
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac Gel | Non-Inflammatory Acne Lesion Counts | Week 5 | 14.37 non-inflammatory acne lesions | Standard Deviation 11.2 |
| Duac Gel | Non-Inflammatory Acne Lesion Counts | Week 8 | 10.81 non-inflammatory acne lesions | Standard Deviation 8.88 |
Secondary
Product Acceptability and Preference Questionnaire - Comfort of Skin
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very comfortable; 2, comfortable; 3, somewhat comfortable; 4, somewhat uncomfortable; 5, uncomfortable.
Time frame: Week 8
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duac Gel | Product Acceptability and Preference Questionnaire - Comfort of Skin | 1.78 Units on a scale | Standard Deviation 0.85 |
Secondary
Product Acceptability and Preference Questionnaire - Comfort of Skin
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very comfortable; 2, comfortable; 3, somewhat comfortable; 4, somewhat uncomfortable; 5, uncomfortable.
Time frame: Week 1, Week 2
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac Gel | Product Acceptability and Preference Questionnaire - Comfort of Skin | Week 1 | 2.38 Units on a scale | Standard Deviation 0.94 |
| Duac Gel | Product Acceptability and Preference Questionnaire - Comfort of Skin | Week 2 | 2.00 Units on a scale | Standard Deviation 0.86 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Comfort of Skin | Week 1 | 2.58 Units on a scale | Standard Deviation 1.24 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Comfort of Skin | Week 2 | 2.25 Units on a scale | Standard Deviation 1.14 |
Secondary
Product Acceptability and Preference Questionnaire - Comparison of Study Products to Products Used in the Past
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, more satisfied; 2, somewhat more satisfied; 3, neither satisfied or dissatisfied; 4, more satisfied; 5, more dissatisfied.
Time frame: Week 8
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duac Gel | Product Acceptability and Preference Questionnaire - Comparison of Study Products to Products Used in the Past | 1.93 Units on a scale | Standard Deviation 1.24 |
Secondary
Product Acceptability and Preference Questionnaire - Compliance
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, non-compliant (\< 50% of the week); 1, mostly compliant (50-79%); 2, very compliant (80-100%).
Time frame: Week 1, Week 2
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac Gel | Product Acceptability and Preference Questionnaire - Compliance | Week 1 | 1.96 Units on a scale | Standard Deviation 0.2 |
| Duac Gel | Product Acceptability and Preference Questionnaire - Compliance | Week 2 | 1.93 Units on a scale | Standard Deviation 0.26 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Compliance | Week 1 | 1.93 Units on a scale | Standard Deviation 0.2 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Compliance | Week 2 | 1.93 Units on a scale | Standard Deviation 0.26 |
Secondary
Product Acceptability and Preference Questionnaire - Compliance
Subject response to question regarding use of the product every day or not at week 8 time point answering Yes or No
Time frame: Week 8
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Duac Gel | Product Acceptability and Preference Questionnaire - Compliance | Yes | 24 Participants |
| Duac Gel | Product Acceptability and Preference Questionnaire - Compliance | No | 3 Participants |
Secondary
Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, highly favorable; 2, favorable; 3, neutral; 4, unfavorable; 5, highly unfavorable.
Time frame: Week 1, Week 2
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac Gel | Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products | Week 1 | 2.27 Units on a scale | Standard Deviation 0.78 |
| Duac Gel | Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products | Week 2 | 2.14 Units on a scale | Standard Deviation 0.8 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products | Week 1 | 2.27 Units on a scale | Standard Deviation 0.72 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products | Week 2 | 2.07 Units on a scale | Standard Deviation 0.81 |
Secondary
Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, highly favorable; 2, favorable; 3, neutral; 4, unfavorable; 5, highly unfavorable.
Time frame: Week 8
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duac Gel | Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products | 2.07 Units on a scale | Standard Deviation 1.14 |
Secondary
Product Acceptability and Preference Questionnaire - Ease of Application of Product
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very easy; 2, easy; 3, neutral; 4, difficult; 5, very difficult.
Time frame: Week 1, Week 2
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac Gel | Product Acceptability and Preference Questionnaire - Ease of Application of Product | Week 1 | 1.46 Units on a scale | Standard Deviation 0.58 |
| Duac Gel | Product Acceptability and Preference Questionnaire - Ease of Application of Product | Week 2 | 1.43 Units on a scale | Standard Deviation 0.5 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Ease of Application of Product | Week 1 | 1.50 Units on a scale | Standard Deviation 0.71 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Ease of Application of Product | Week 2 | 1.50 Units on a scale | Standard Deviation 0.84 |
Secondary
Product Acceptability and Preference Questionnaire - Ease of Application of Product
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very easy; 2, easy; 3, neutral; 4, difficult; 5, very difficult.
Time frame: Week 8
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duac Gel | Product Acceptability and Preference Questionnaire - Ease of Application of Product | 1.26 Units on a scale | Standard Deviation 0.45 |
Secondary
Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, not applicable; 1, very easy; 2, easy; 3, neutral; 4, difficult.
Time frame: Week 1, Week 2
Population: ITT. All participants were asked to respond to the questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac Gel | Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up | Week 1 | 2.31 Units on a scale | Standard Deviation 1.11 |
| Duac Gel | Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up | Week 2 | 1.59 Units on a scale | Standard Deviation 0.87 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up | Week 1 | 2.38 Units on a scale | Standard Deviation 1.12 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up | Week 2 | 1.59 Units on a scale | Standard Deviation 0.87 |
Secondary
Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up
Measure Description Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, not applicable; 1, very easy; 2, easy; 3, neutral; 4, difficult.
Time frame: Week 8
Population: ITT. All participants were asked to respond to the questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duac Gel | Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up | 1.89 Units on a scale | Standard Deviation 0.96 |
Secondary
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin
Subject response to question: did you feel that your skin was hydrated and moisturized while you on your study product? (Yes or No).
Time frame: Week 8
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Duac Gel | Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin | Yes | 24 Participants |
| Duac Gel | Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin | No | 3 Participants |
Secondary
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin
Subject response to question: did you feel that your skin was hydrated and moisturized while you on your study product? (Yes or No).
Time frame: Week 1, Week 2
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Duac Gel | Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin | Week 1 - Yes | 18 Participants |
| Duac Gel | Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin | Week 1 - No | 8 Participants |
| Duac Gel | Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin | Week 2 - Yes | 19 Participants |
| Duac Gel | Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin | Week 2 - No | 8 Participants |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin | Week 2 - No | 9 Participants |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin | Week 1 - Yes | 16 Participants |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin | Week 2 - Yes | 18 Participants |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin | Week 1 - No | 10 Participants |
Secondary
Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very satisfied; 2, satisfied; 3, neutral; 4, unsatisfied; 5, very unsatisfied.
Time frame: Week 8
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duac Gel | Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product | 2.52 Units on a scale | Standard Deviation 1.37 |
Secondary
Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very satisfied; 2, satisfied; 3, neutral; 4, unsatisfied; 5, very unsatisfied.
Time frame: Week 1, Week 2
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac Gel | Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product | Week 1 | 2.04 Units on a scale | Standard Deviation 0.92 |
| Duac Gel | Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product | Week 2 | 2.21 Units on a scale | Standard Deviation 1.17 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product | Week 1 | 2.19 Units on a scale | Standard Deviation 1.06 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product | Week 2 | 2.32 Units on a scale | Standard Deviation 1.16 |
Secondary
Product Acceptability and Preference Questionnaire - Severity of Burning
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Time frame: Week 1, Week 2
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac Gel | Product Acceptability and Preference Questionnaire - Severity of Burning | Week 1 | 1.12 Units on a scale | Standard Deviation 1.24 |
| Duac Gel | Product Acceptability and Preference Questionnaire - Severity of Burning | Week 2 | 0.73 Units on a scale | Standard Deviation 0.92 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Severity of Burning | Week 1 | 1.96 Units on a scale | Standard Deviation 1.61 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Severity of Burning | Week 2 | 1.11 Units on a scale | Standard Deviation 1.31 |
Secondary
Product Acceptability and Preference Questionnaire - Severity of Burning
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Time frame: Week 8
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duac Gel | Product Acceptability and Preference Questionnaire - Severity of Burning | 0.63 Units on a scale | Standard Deviation 0.93 |
Secondary
Product Acceptability and Preference Questionnaire - Severity of Dryness
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Time frame: Week 1, Week 2
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac Gel | Product Acceptability and Preference Questionnaire - Severity of Dryness | Week 1 | 1.42 Units on a scale | Standard Deviation 1.36 |
| Duac Gel | Product Acceptability and Preference Questionnaire - Severity of Dryness | Week 2 | 1.31 Units on a scale | Standard Deviation 1.23 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Severity of Dryness | Week 1 | 1.88 Units on a scale | Standard Deviation 1.82 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Severity of Dryness | Week 2 | 1.58 Units on a scale | Standard Deviation 1.27 |
Secondary
Product Acceptability and Preference Questionnaire - Severity of Dryness
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Time frame: Week 8
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duac Gel | Product Acceptability and Preference Questionnaire - Severity of Dryness | 1.22 Units on a scale | Standard Deviation 1.12 |
Secondary
Product Acceptability and Preference Questionnaire - Severity of Itching
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Time frame: Week 8
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duac Gel | Product Acceptability and Preference Questionnaire - Severity of Itching | 0.63 Units on a scale | Standard Deviation 1.01 |
Secondary
Product Acceptability and Preference Questionnaire - Severity of Itching
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Time frame: Week 1, Week 2
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac Gel | Product Acceptability and Preference Questionnaire - Severity of Itching | Week 1 | 1.19 Units on a scale | Standard Deviation 1.13 |
| Duac Gel | Product Acceptability and Preference Questionnaire - Severity of Itching | Week 2 | 0.81 Units on a scale | Standard Deviation 1.02 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Severity of Itching | Week 1 | 1.42 Units on a scale | Standard Deviation 1.3 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Severity of Itching | Week 2 | 1.19 Units on a scale | Standard Deviation 1.27 |
Secondary
Product Acceptability and Preference Questionnaire - Severity of Redness
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Time frame: Week 8
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duac Gel | Product Acceptability and Preference Questionnaire - Severity of Redness | 1.00 Units on a scale | Standard Deviation 1.14 |
Secondary
Product Acceptability and Preference Questionnaire - Severity of Redness
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Time frame: Week 1, Week 2
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac Gel | Product Acceptability and Preference Questionnaire - Severity of Redness | Week 1 | 1.12 Units on a scale | Standard Deviation 1.24 |
| Duac Gel | Product Acceptability and Preference Questionnaire - Severity of Redness | Week 2 | 0.78 Units on a scale | Standard Deviation 0.8 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Severity of Redness | Week 1 | 1.54 Units on a scale | Standard Deviation 1.36 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Severity of Redness | Week 2 | 1.00 Units on a scale | Standard Deviation 0.89 |
Secondary
Product Acceptability and Preference Questionnaire - Severity of Scaling
Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Time frame: Week 1, Week 2
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac Gel | Product Acceptability and Preference Questionnaire - Severity of Scaling | Week 1 | 0.77 Units on a scale | Standard Deviation 1.07 |
| Duac Gel | Product Acceptability and Preference Questionnaire - Severity of Scaling | Week 2 | 0.69 Units on a scale | Standard Deviation 0.93 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Severity of Scaling | Week 1 | 1.15 Units on a scale | Standard Deviation 1.32 |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Severity of Scaling | Week 2 | 1.00 Units on a scale | Standard Deviation 1.17 |
Secondary
Product Acceptability and Preference Questionnaire - Severity of Scaling
Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Time frame: Week 8
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duac Gel | Product Acceptability and Preference Questionnaire - Severity of Scaling | 0.78 Units on a scale | Standard Deviation 1.28 |
Secondary
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment
Subject response to the following question: If you were to choose to continue treatment for your acne, which treatment would you choose? (Yes or No).
Time frame: Week 1, Week 2
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Duac Gel | Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment | Week 1 - Yes | 19 Participants |
| Duac Gel | Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment | Week 1 - No | 5 Participants |
| Duac Gel | Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment | Week 2 - Yes | 16 Participants |
| Duac Gel | Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment | Week 2 - No | 10 Participants |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment | Week 2 - No | 9 Participants |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment | Week 1 - Yes | 15 Participants |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment | Week 2 - Yes | 18 Participants |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment | Week 1 - No | 10 Participants |
Secondary
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment
Subject response to the following question: If you were to choose to continue treatment for your acne, which treatment would you choose? (Yes or No).
Time frame: Week 8
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Duac Gel | Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment | Yes | 20 Participants |
| Duac Gel | Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment | No | 7 Participants |
Secondary
Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With?
Product Acceptability and Preference Questionnaire was completed by the subject at week 1 and week 2 asking which study product they were more satisfied with: Duac or Epiduo.
Time frame: Week 1, Week 2
Population: ITT. Some participants missed a visit and therefore were not included in the number of participants analyzed for that visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Duac Gel | Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With? | Week 1 | 17 Participants |
| Duac Gel | Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With? | Week 2 | 12 Participants |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With? | Week 1 | 8 Participants |
| Epiduo Gel | Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With? | Week 2 | 15 Participants |
Secondary
Skindex-29 Quality of Life Questionnaire - Emotional Domain
Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: never to all the time, higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain.
Time frame: Baseline, and Week 8
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac Gel | Skindex-29 Quality of Life Questionnaire - Emotional Domain | Baseline | 44.29 Units on a scale | Standard Deviation 28.03 |
| Duac Gel | Skindex-29 Quality of Life Questionnaire - Emotional Domain | Week 8 | 35.37 Units on a scale | Standard Deviation 26.03 |
Secondary
Skindex-29 Quality of Life Questionnaire - Functional Domain
Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: never to all the time, higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain.
Time frame: Baseline, and Week 8
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac Gel | Skindex-29 Quality of Life Questionnaire - Functional Domain | Baseline | 14.06 Units on a scale | Standard Deviation 13.41 |
| Duac Gel | Skindex-29 Quality of Life Questionnaire - Functional Domain | Week 8 | 9.10 Units on a scale | Standard Deviation 10.39 |
Secondary
Skindex-29 Quality of Life Questionnaire - Global Score
Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: never to all the time, higher scores for each domain indicate worse effects on QoL. The Global Score ranges from 0 to 100. Higher scores indicate worse QoL for that domain.
Time frame: Baseline, and Week 8
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac Gel | Skindex-29 Quality of Life Questionnaire - Global Score | Baseline | 14.06 Units on a scale | Standard Deviation 13.41 |
| Duac Gel | Skindex-29 Quality of Life Questionnaire - Global Score | Week 8 | 9.10 Units on a scale | Standard Deviation 10.39 |
Secondary
Skindex-29 Quality of Life Questionnaire - Symptomatic Domain
Skindex-29 Quality of Life (QoL) Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: never to all the time, higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain.
Time frame: Baseline, and Week 8
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac Gel | Skindex-29 Quality of Life Questionnaire - Symptomatic Domain | Baseline | 28.10 Units on a scale | Standard Deviation 17.01 |
| Duac Gel | Skindex-29 Quality of Life Questionnaire - Symptomatic Domain | Week 8 | 21.72 Units on a scale | Standard Deviation 11.6 |
Secondary
Skin Dryness Score
Investigator assessment of tolerability (skin dryness) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Time frame: Week 5, Week 8
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac Gel | Skin Dryness Score | Week 5 | 0.15 Units on a scale | Standard Deviation 0.46 |
| Duac Gel | Skin Dryness Score | Week 8 | 0.00 Units on a scale | Standard Deviation 0 |
Secondary
Skin Peeling Score
Investigator assessment of tolerability (skin peeling) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Time frame: Week 5, Week 8
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac Gel | Skin Peeling Score | Week 5 | 0.00 Units on a scale | Standard Deviation 0 |
| Duac Gel | Skin Peeling Score | Week 8 | 0.00 Units on a scale | Standard Deviation 0 |
Secondary
Total Acne Lesion Counts
Total acne lesion counts - includes both inflammatory acne lesions (pustules, papules), noninflammatory lesions (whiteheads and blackheads),
Time frame: Week 5, Week 8
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac Gel | Total Acne Lesion Counts | Week 5 | 22.81 total acne lesions | Standard Deviation 14.87 |
| Duac Gel | Total Acne Lesion Counts | Week 8 | 17.81 total acne lesions | Standard Deviation 14.04 |