Acne Vulgaris
Conditions
Keywords
twice daily, once daily, CLDM 1%-BPO 3% gel, Clindamycin (CLDM), benzoyl peroxide (BPO), inflammatory lesion, non-inflammatory lesion, acne vulgaris
Brief summary
This is a multicenter, randomized, single-blinded (investigator's blinded), active-controlled (clindamycin \[CLDM\] 1% gel), parallel-group study in Japanese subjects with acne vulgaris to demonstrate the efficacy of GSK2585823 (CLDM 1%-benzoyl peroxide \[BPO\] 3% gel) when applied once or twice daily for 12 weeks. This study will also evaluate the safety of GSK2585823 when applied topically either once or twice daily for 12 weeks.
Detailed description
Main inclusion criteria will be 12 to 45 years of age, who have an Investigator Static Global Assessment (ISGA) score of 2 or greater at baseline visit, and have both 17 to 60 facial inflammatory lesions (papules plus pustules) and 20 to 150 facial non-inflammatory lesions (open and closed comedones), including nasal lesions. The primary objectives are to demonstrate the superiority of GSK2585823 twice daily to CLDM twice daily in total lesion counts, and to demonstrate the non-inferiority of GSK2585823 once daily to CLDM twice daily in total lesion counts. The secondary objectives are to demonstrate the non-inferiority of GSK2585823 once daily to CLDM twice daily in inflammatory lesion counts, and to evaluate the efficacy of GSK2585823 once or twice daily compared with CLDM twice daily at each visit. A total of 800 subjects will be enrolled and randomly assigned to one of the groups.
Interventions
DRUGGSK2585823(CLDM 1%-BPO 3% gel)
Topical gel in 1 g containing clindamycin 10 mg and benzoyl peroxide 30 mg
DRUGCLDM 1% gel twice daily
Topical gel containing clindamycin 10 mg/1 g gel
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Male or female subjects 12 to 45 years (inclusive) of age in good general health. * Subjects must have both on the face: A) A minimum of 17 but not more than 60 inflammatory lesions (papules/pustules), including nasal lesions. And B) A minimum of 20 but not more than 150 non-inflammatory lesions (open/closed comedones), including nasal lesions. * An ISGA score of 2 or greater at baseline. * Females of childbearing potential and women who are less than 2 years from their last menses must agree to use the contraception. * The ability and willingness to follow all study procedures and attend all scheduled visits. * The ability to understand and sign a written informed consent form (Written informed consent must be obtained also from the parent or guardian in case of subject under 20 years of age at the time of given consent).
Exclusion criteria
* Have any nodule-cystic lesions at baseline. * Are pregnant or breast-feeding. * Have a history or presence of regional enteritis, inflammatory bowel disease (e.g., ulcerative colitis, pseudomembranous colitis, chronic diarrhea or antibiotic-associated colitis) or similar symptoms. * Used any of the following agents on the face within the previous 2 weeks:Topical antibiotics (or systemic antibiotics);Topical anti-acne medications (e.g., BPO, azelaic acid, resorcinol, salicylates);Abradants, facials, or peels containing glycolic or other acids;Masks, washes or soaps containing BPO, sulfacetamide sodium, or salicylic acid;Non-mild facial cleansers (e.g., facial scrub, cleansers containing agents with anti-inflammatory action); Moisturizers that contain retinol, salicylic acid, or α- or β-hydroxy acids;Astringents and toner (Subjects are allowed to enroll in this study, if the subject has been on treatment for more than 2 consecutive weeks prior to start of investigational product use). * Used the following agents on the face or performed the following procedure within the previous 4 weeks:Topical corticosteroids (Use of inhaled, intra-articular, or intra-lesional steroids other than for facial acne is acceptable);Facial procedure (such as chemical or laser peel, microdermabrasion, blue light treatment, etc.). * Used systemic retinoids within the previous 6 months or topical retinoids on the face within the previous 6 weeks. * Received treatment with estrogens, androgens, or anti-androgenic agents within the previous 12 weeks (Subjects who have been treated with the above agents for more than 12 consecutive weeks prior to start of investigational product are allowed to enrol as long as they do not expect to change dose, drug, or discontinue use during the study). * Used any medication that in the opinion of the investigator may affect this clinical study or evaluation of the study. * Plan to use medications that are reported to exacerbate acne (e.g., mega-doses of certain vitamins, such as vitamin D \[\>2000 IU/day\] and vitamin B12 \[\>1 mg/day\], corticosteroids\*, androgens, haloperidol, halogens \[e.g., iodide and bromide\], lithium, hydantoin, and phenobarbital). \*: except the using of topical corticosteroids (e.g., inhaled, intra-articular, or intra-lesional steroids) other than for facial acne. * Have a known hypersensitivity or have had previous allergic reaction to any of the components of the investigational product. * Used any investigational therapy within the previous 12 weeks, or plan to participate in another clinical study at the same time. * Participated in Japanese clinical studies planned by GlaxoSmithKline K.K. in the development of investigational products for acne vulgaris. * Are currently abusing drugs or alcohol. * Have a significant medical history of being immunocompromised. * People as follows and the family members:Employees of GlaxoSmithKline, contract research organization (CRO) or site management organization (SMO);Investigators. * Have other conditions that would put the subject at unacceptable risk for participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change From Baseline to Week 12 in Total Lesion Counts. | Baseline (Day 1) and Week 12 | The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from post-randomization value at Week 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts | Baseline (Day 1) and Weeks 1, 2, 4, 8, and 12 | The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from value at indicated time points. |
| Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Baseline (Day 1) and Weeks 1, 2, 4, 8, and 12 | The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from value at indicated time points.( Weeks 1, 2, 4, 8 and 12) |
| Percentage of Participants With a Minimum 2-grade Improvement From Baseline to Week 12 in Investigator's Static Global Assessment (ISGA) Score | Baseline (Day 1) and Week 12 | Proportion of participants with at least a 2-Grade Improvement in ISGA was reported using a 5 point scale which indicates Score 0 (Clear): skin with no inflammatory or non-inflammatory lesions, Score 1 (Almost Clear): rare non-inflammatory lesions with no more than rare papules, Score 2 (Mild): greater than Grade 1, some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions), Score 3 (Moderate): greater than Grade 2, many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion, Score 4 (Severe): greater than Grade 3, many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions and 5(very severe): many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions. The investigator assessed ISGA score at baseline (Week 0/Day 1) and Weeks 1, 2, 4, 8, and 12. The area evaluated ISGA was limited to the face. |
| Percentage of Participants With an ISGA Score of 0 (Clear) or 1 (Almost Clear) at Weeks 1, 2, 4, 8, and 12 | Week 1, 2, 4, 8, and 12 | Proportion of participants with at least a 2-Grade Improvement in ISGA was reported using a 5 point scale which indicates Score 0 (Clear): skin with no inflammatory or non-inflammatory lesions, Score 1 (Almost Clear): rare non-inflammatory lesions with no more than rare papules, Score 2 (Mild): greater than Grade 1, some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions), Score 3 (Moderate): greater than Grade 2, many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion, Score 4 (Severe): greater than Grade 3, many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions and 5 (very severe): many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions. The investigator assessed ISGA score at baseline (Week 0/Day 1) and Weeks 1, 2, 4, 8, and 12. The area evaluated ISGA was limited to the face. |
| Absolute Change From Baseline to Weeks 1, 2, 4, and 8 in Total Lesion Counts | Baseline (Day 1) and Weeks 1, 2, 4, and 8 | The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from value at indicated time points. |
| Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX) | Baseline (Day 1) and Week12 | MIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism). MIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism) for the susceptibility of clinical isolates (Propionibacterium acnes before and after application of the CLDM and NDFX was reported. MIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis. |
| Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Baseline (Day 1) and Week 1, 2, 4, 8, and 12 | Erythema (redness), dryness, and peeling, were evaluated independently by the investigator on a five point scale from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Day 1 was Baseline and Change from Baseline was calculated by subtracting Baseline value from value at specified time points (Week 1, 2, 4, 8, and 12). |
| Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12 | Baseline (Day 1) and Week 1, 2, 4, 8 and 12 | Burning/stinging, itching were evaluated independently by the participant on a five point scale from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Day 1 was Baseline and Change from Baseline was calculated by subtracting Baseline value from value at specified time points (Week 1, 2, 4, 8, and 12). |
| Percentage of Participants Who Have a Reduction of at Least 50 Percent in Total Lesions | Baseline (Day 1) and Week 1, 2, 4, 8, and 12 | The percentage of participants who had reduction in total lesions (inflammatory and non-inflammatory) of at least 50 percent from Baseline at Weeks 1, 2, 4, 8, and 12 was measured. |
Countries
Japan
Participant flow
Recruitment details
A total of 800 Japanese participants across 26 investigational centers in Japan, with Acne Vulgaris were enrolled in this study. The study was conducted from 27 September 2011 - 02 August 2012.
Participants by arm
| Arm | Count |
|---|---|
| GSK2585823 Once Daily Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU. | 204 |
| GSK2585823 Twice Daily Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU. | 296 |
| CLDM Twice Daily Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU. | 299 |
| Total | 799 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 15 | 25 | 4 |
| Overall Study | Lack of Efficacy | 0 | 1 | 0 |
| Overall Study | Physician Decision | 0 | 2 | 0 |
| Overall Study | Protocol-Defined Stopping Criteria | 0 | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 6 | 4 |
Baseline characteristics
| Characteristic | GSK2585823 Once Daily | GSK2585823 Twice Daily | CLDM Twice Daily | Total |
|---|---|---|---|---|
| Age, Continuous | 20.4 Years STANDARD_DEVIATION 6.06 | 20.7 Years STANDARD_DEVIATION 6.33 | 21.1 Years STANDARD_DEVIATION 6.55 | 20.8 Years STANDARD_DEVIATION 6.34 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 204 Participants | 296 Participants | 299 Participants | 799 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 139 Participants | 187 Participants | 202 Participants | 528 Participants |
| Sex: Female, Male Male | 65 Participants | 109 Participants | 97 Participants | 271 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 204 | 0 / 296 | 0 / 299 |
| other Total, other adverse events | 108 / 204 | 163 / 296 | 110 / 299 |
| serious Total, serious adverse events | 0 / 204 | 0 / 296 | 0 / 299 |
Outcome results
Primary
Absolute Change From Baseline to Week 12 in Total Lesion Counts.
The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from post-randomization value at Week 12.
Time frame: Baseline (Day 1) and Week 12
Population: ITT population. Only those participants available at the indicated time points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| GSK2585823 Once Daily | Absolute Change From Baseline to Week 12 in Total Lesion Counts. | -57.2 lesion count | Standard Error 1.94 |
| GSK2585823 Twice Daily | Absolute Change From Baseline to Week 12 in Total Lesion Counts. | -60.8 lesion count | Standard Error 1.53 |
| CLDM Twice Daily | Absolute Change From Baseline to Week 12 in Total Lesion Counts. | -49.8 lesion count | Standard Error 1.52 |
p-value: <0.00195% CI: [-15, -7]ANCOVA
p-value: <0.00195% CI: [-12.9, -3.6]ANCOVA
Secondary
Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts
The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from value at indicated time points.
Time frame: Baseline (Day 1) and Weeks 1, 2, 4, 8, and 12
Population: ITT population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2585823 Once Daily | Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts | Inflammatory lesions,Week 1 | -11.5 Lesion count | Standard Error 0.6 |
| GSK2585823 Once Daily | Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts | Inflammatory lesions,Week 2 | -14.8 Lesion count | Standard Error 0.9 |
| GSK2585823 Once Daily | Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts | Inflammatory lesions,Week 4 | -18.3 Lesion count | Standard Error 0.93 |
| GSK2585823 Once Daily | Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts | Inflammatory lesions,Week 8 | -21.0 Lesion count | Standard Error 0.98 |
| GSK2585823 Once Daily | Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts | Inflammatory lesions,Week 12 | -22.9 Lesion count | Standard Error 0.99 |
| GSK2585823 Once Daily | Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts | Non-Inflammatory lesions,Week 1 | -13.1 Lesion count | Standard Error 1.26 |
| GSK2585823 Once Daily | Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts | Non-Inflammatory lesions,Week 2 | -20.3 Lesion count | Standard Error 1.53 |
| GSK2585823 Once Daily | Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts | Non-Inflammatory lesions,Week 4 | -25.2 Lesion count | Standard Error 1.58 |
| GSK2585823 Once Daily | Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts | Non-Inflammatory lesions,Week 8 | -30.4 Lesion count | Standard Error 1.62 |
| GSK2585823 Once Daily | Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts | Non-Inflammatory lesions,Week 12 | -34.3 Lesion count | Standard Error 1.6 |
| GSK2585823 Twice Daily | Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts | Non-Inflammatory lesions,Week 8 | -33.9 Lesion count | Standard Error 1.36 |
| GSK2585823 Twice Daily | Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts | Inflammatory lesions,Week 1 | -11.1 Lesion count | Standard Error 0.54 |
| GSK2585823 Twice Daily | Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts | Non-Inflammatory lesions,Week 1 | -15.6 Lesion count | Standard Error 1.08 |
| GSK2585823 Twice Daily | Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts | Inflammatory lesions,Week 12 | -23.3 Lesion count | Standard Error 0.69 |
| GSK2585823 Twice Daily | Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts | Inflammatory lesions,Week 2 | -16.4 Lesion count | Standard Error 0.61 |
| GSK2585823 Twice Daily | Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts | Non-Inflammatory lesions,Week 12 | -37.5 Lesion count | Standard Error 1.31 |
| GSK2585823 Twice Daily | Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts | Non-Inflammatory lesions,Week 4 | -28.9 Lesion count | Standard Error 1.33 |
| GSK2585823 Twice Daily | Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts | Inflammatory lesions,Week 4 | -19.1 Lesion count | Standard Error 0.62 |
| GSK2585823 Twice Daily | Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts | Non-Inflammatory lesions,Week 2 | -22.8 Lesion count | Standard Error 1.28 |
| GSK2585823 Twice Daily | Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts | Inflammatory lesions,Week 8 | -21.3 Lesion count | Standard Error 0.69 |
| CLDM Twice Daily | Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts | Non-Inflammatory lesions,Week 4 | -19.4 Lesion count | Standard Error 1.32 |
| CLDM Twice Daily | Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts | Inflammatory lesions,Week 8 | -18.3 Lesion count | Standard Error 0.82 |
| CLDM Twice Daily | Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts | Inflammatory lesions,Week 12 | -20.3 Lesion count | Standard Error 0.83 |
| CLDM Twice Daily | Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts | Non-Inflammatory lesions,Week 1 | -9.7 Lesion count | Standard Error 1.06 |
| CLDM Twice Daily | Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts | Non-Inflammatory lesions,Week 8 | -24.9 Lesion count | Standard Error 1.36 |
| CLDM Twice Daily | Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts | Non-Inflammatory lesions,Week 2 | -14.9 Lesion count | Standard Error 1.29 |
| CLDM Twice Daily | Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts | Inflammatory lesions,Week 1 | -8.5 Lesion count | Standard Error 0.5 |
| CLDM Twice Daily | Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts | Non-Inflammatory lesions,Week 12 | -28.7 Lesion count | Standard Error 1.34 |
| CLDM Twice Daily | Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts | Inflammatory lesions,Week 2 | -13.1 Lesion count | Standard Error 0.76 |
| CLDM Twice Daily | Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts | Inflammatory lesions,Week 4 | -16.3 Lesion count | Standard Error 0.78 |
Comparison: WEEK 1p-value: <0.00195% CI: [-4.4, -1.5]ANCOVA
Comparison: WEEK 2p-value: 0.11395% CI: [-4, 0.4]ANCOVA
Comparison: WEEK 4p-value: 0.08495% CI: [-4.2, 0.3]ANCOVA
Comparison: WEEK 8p-value: 0.02695% CI: [-5.1, -0.3]ANCOVA
Comparison: WEEK 12p-value: 0.0395% CI: [-5, -0.3]ANCOVA
Comparison: WEEK 1p-value: 0.02895% CI: [-6.5, -0.4]ANCOVA
Comparison: WEEK 2p-value: 0.00495% CI: [-9.1, -1.7]ANCOVA
Comparison: WEEK 2p-value: <0.00195% CI: [-4.7, -1.6]ANCOVA
Comparison: WEEK 4p-value: 0.00395% CI: [-9.6, -1.9]ANCOVA
Comparison: WEEK 8p-value: 0.00695% CI: [-9.4, -1.6]ANCOVA
Comparison: WEEK 12p-value: 0.00595% CI: [-9.5, -1.7]ANCOVA
Comparison: WEEK 1p-value: <0.00195% CI: [-3.9, -1.1]ANCOVA
Comparison: WEEK 12p-value: 0.00295% CI: [-4.6, -1]ANCOVA
Comparison: WEEK 4p-value: 0.00295% CI: [-4.1, -0.9]ANCOVA
Comparison: WEEK 8p-value: 0.00395% CI: [-4.5, -0.9]ANCOVA
Comparison: WEEK 1p-value: <0.00195% CI: [-8.8, -3.2]ANCOVA
Comparison: WEEK 2p-value: <0.00195% CI: [-11.4, -4.7]ANCOVA
Comparison: WEEK 4p-value: <0.00195% CI: [-13.1, -6.2]ANCOVA
Comparison: WEEK 8p-value: <0.00195% CI: [-12.1, -5.1]ANCOVA
Comparison: WEEK 12p-value: <0.00195% CI: [-11.6, -4.8]ANCOVA
Secondary
Absolute Change From Baseline to Weeks 1, 2, 4, and 8 in Total Lesion Counts
The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from value at indicated time points.
Time frame: Baseline (Day 1) and Weeks 1, 2, 4, and 8
Population: ITT population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2585823 Once Daily | Absolute Change From Baseline to Weeks 1, 2, 4, and 8 in Total Lesion Counts | WEEK 1 | -22.9 lesion count | Standard Deviation 19.81 |
| GSK2585823 Once Daily | Absolute Change From Baseline to Weeks 1, 2, 4, and 8 in Total Lesion Counts | WEEK 2 | -32.9 lesion count | Standard Deviation 29.18 |
| GSK2585823 Once Daily | Absolute Change From Baseline to Weeks 1, 2, 4, and 8 in Total Lesion Counts | WEEK 4 | -41.4 lesion count | Standard Deviation 27.41 |
| GSK2585823 Once Daily | Absolute Change From Baseline to Weeks 1, 2, 4, and 8 in Total Lesion Counts | WEEK 8 | -49.1 lesion count | Standard Deviation 28.97 |
| GSK2585823 Twice Daily | Absolute Change From Baseline to Weeks 1, 2, 4, and 8 in Total Lesion Counts | WEEK 8 | -54.4 lesion count | Standard Deviation 34.65 |
| GSK2585823 Twice Daily | Absolute Change From Baseline to Weeks 1, 2, 4, and 8 in Total Lesion Counts | WEEK 1 | -25.6 lesion count | Standard Deviation 24.91 |
| GSK2585823 Twice Daily | Absolute Change From Baseline to Weeks 1, 2, 4, and 8 in Total Lesion Counts | WEEK 4 | -47.3 lesion count | Standard Deviation 31.04 |
| GSK2585823 Twice Daily | Absolute Change From Baseline to Weeks 1, 2, 4, and 8 in Total Lesion Counts | WEEK 2 | -37.9 lesion count | Standard Deviation 28.91 |
| CLDM Twice Daily | Absolute Change From Baseline to Weeks 1, 2, 4, and 8 in Total Lesion Counts | WEEK 8 | -42.7 lesion count | Standard Deviation 33.49 |
| CLDM Twice Daily | Absolute Change From Baseline to Weeks 1, 2, 4, and 8 in Total Lesion Counts | WEEK 2 | -26.6 lesion count | Standard Deviation 30 |
| CLDM Twice Daily | Absolute Change From Baseline to Weeks 1, 2, 4, and 8 in Total Lesion Counts | WEEK 4 | -34.8 lesion count | Standard Deviation 30.92 |
| CLDM Twice Daily | Absolute Change From Baseline to Weeks 1, 2, 4, and 8 in Total Lesion Counts | WEEK 1 | -16.9 lesion count | Standard Deviation 24.4 |
Secondary
Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12
Erythema (redness), dryness, and peeling, were evaluated independently by the investigator on a five point scale from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Day 1 was Baseline and Change from Baseline was calculated by subtracting Baseline value from value at specified time points (Week 1, 2, 4, 8, and 12).
Time frame: Baseline (Day 1) and Week 1, 2, 4, 8, and 12
Population: ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2585823 Once Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Dryness yscore-Week 1 | 0.10 Score on scale | Standard Deviation 0.65 |
| GSK2585823 Once Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Erythema score-Week 4 | -0.30 Score on scale | Standard Deviation 0.72 |
| GSK2585823 Once Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Peeling score-Week 1 | 0.09 Score on scale | Standard Deviation 0.5 |
| GSK2585823 Once Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Dryness score-Week 2 | 0.04 Score on scale | Standard Deviation 0.65 |
| GSK2585823 Once Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Erythema score-Week 2 | -0.16 Score on scale | Standard Deviation 0.76 |
| GSK2585823 Once Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Dryness score-Week 12 | -0.18 Score on scale | Standard Deviation 0.62 |
| GSK2585823 Once Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Dryness score-Week 4 | -0.06 Score on scale | Standard Deviation 0.57 |
| GSK2585823 Once Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Peeling score-Week 4 | -0.05 Score on scale | Standard Deviation 0.44 |
| GSK2585823 Once Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Dryness score-Week 8 | -0.11 Score on scale | Standard Deviation 0.61 |
| GSK2585823 Once Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Erythema score-Week 8 | -0.43 Score on scale | Standard Deviation 0.82 |
| GSK2585823 Once Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Peeling score-Week 12 | -0.08 Score on scale | Standard Deviation 0.49 |
| GSK2585823 Once Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Erythema score-Week 1 | -0.11 Score on scale | Standard Deviation 0.58 |
| GSK2585823 Once Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Erythema score-Week 12 | -0.49 Score on scale | Standard Deviation 0.82 |
| GSK2585823 Once Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Peeling score-Week 8 | -0.08 Score on scale | Standard Deviation 0.46 |
| GSK2585823 Once Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Peeling score-Week 2 | 0.02 Score on scale | Standard Deviation 0.49 |
| GSK2585823 Twice Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Peeling score-Week 2 | 0.17 Score on scale | Standard Deviation 0.68 |
| GSK2585823 Twice Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Erythema score-Week 1 | -0.00 Score on scale | Standard Deviation 0.63 |
| GSK2585823 Twice Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Erythema score-Week 2 | -0.02 Score on scale | Standard Deviation 0.82 |
| GSK2585823 Twice Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Erythema score-Week 4 | -0.24 Score on scale | Standard Deviation 0.75 |
| GSK2585823 Twice Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Erythema score-Week 8 | -0.33 Score on scale | Standard Deviation 0.78 |
| GSK2585823 Twice Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Erythema score-Week 12 | -0.45 Score on scale | Standard Deviation 0.87 |
| GSK2585823 Twice Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Dryness yscore-Week 1 | 0.29 Score on scale | Standard Deviation 0.76 |
| GSK2585823 Twice Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Dryness score-Week 2 | 0.23 Score on scale | Standard Deviation 0.8 |
| GSK2585823 Twice Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Dryness score-Week 4 | 0.00 Score on scale | Standard Deviation 0.65 |
| GSK2585823 Twice Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Dryness score-Week 8 | -0.00 Score on scale | Standard Deviation 0.67 |
| GSK2585823 Twice Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Dryness score-Week 12 | -0.10 Score on scale | Standard Deviation 0.61 |
| GSK2585823 Twice Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Peeling score-Week 1 | 0.19 Score on scale | Standard Deviation 0.68 |
| GSK2585823 Twice Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Peeling score-Week 4 | 0.04 Score on scale | Standard Deviation 0.54 |
| GSK2585823 Twice Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Peeling score-Week 8 | 0.03 Score on scale | Standard Deviation 0.56 |
| GSK2585823 Twice Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Peeling score-Week 12 | -0.07 Score on scale | Standard Deviation 0.51 |
| CLDM Twice Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Dryness yscore-Week 1 | -0.04 Score on scale | Standard Deviation 0.47 |
| CLDM Twice Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Peeling score-Week 8 | -0.13 Score on scale | Standard Deviation 0.43 |
| CLDM Twice Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Peeling score-Week 1 | -0.04 Score on scale | Standard Deviation 0.39 |
| CLDM Twice Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Erythema score-Week 12 | -0.38 Score on scale | Standard Deviation 0.75 |
| CLDM Twice Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Erythema score-Week 8 | -0.31 Score on scale | Standard Deviation 0.67 |
| CLDM Twice Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Peeling score-Week 2 | -0.10 Score on scale | Standard Deviation 0.39 |
| CLDM Twice Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Erythema score-Week 4 | -0.27 Score on scale | Standard Deviation 0.62 |
| CLDM Twice Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Erythema score-Week 1 | -0.11 Score on scale | Standard Deviation 0.52 |
| CLDM Twice Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Peeling score-Week 4 | -0.14 Score on scale | Standard Deviation 0.43 |
| CLDM Twice Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Dryness score-Week 4 | -0.15 Score on scale | Standard Deviation 0.53 |
| CLDM Twice Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Erythema score-Week 2 | -0.19 Score on scale | Standard Deviation 0.58 |
| CLDM Twice Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Dryness score-Week 8 | -0.13 Score on scale | Standard Deviation 0.5 |
| CLDM Twice Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Dryness score-Week 2 | -0.11 Score on scale | Standard Deviation 0.51 |
| CLDM Twice Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Peeling score-Week 12 | -0.13 Score on scale | Standard Deviation 0.44 |
| CLDM Twice Daily | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Dryness score-Week 12 | -0.17 Score on scale | Standard Deviation 0.52 |
Secondary
Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12
Burning/stinging, itching were evaluated independently by the participant on a five point scale from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Day 1 was Baseline and Change from Baseline was calculated by subtracting Baseline value from value at specified time points (Week 1, 2, 4, 8, and 12).
Time frame: Baseline (Day 1) and Week 1, 2, 4, 8 and 12
Population: ITT population. Only those participants available at the specified time points were analyzed (represented by n=X. X, X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2585823 Once Daily | Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12 | Itching Score, Week 1 | -0.02 Score on scale | Standard Deviation 0.53 |
| GSK2585823 Once Daily | Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12 | Itching Score, Week 2 | -0.06 Score on scale | Standard Deviation 0.58 |
| GSK2585823 Once Daily | Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12 | Itching Score, Week 4 | -0.10 Score on scale | Standard Deviation 0.51 |
| GSK2585823 Once Daily | Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12 | Itching Score, Week 8 | -0.15 Score on scale | Standard Deviation 0.5 |
| GSK2585823 Once Daily | Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12 | Itching Score, Week 12 | -0.10 Score on scale | Standard Deviation 0.59 |
| GSK2585823 Once Daily | Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12 | Burning/Stinging Score, Week 1 | 0.08 Score on scale | Standard Deviation 0.55 |
| GSK2585823 Once Daily | Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12 | Burning/Stinging Score, Week 2 | 0.02 Score on scale | Standard Deviation 0.45 |
| GSK2585823 Once Daily | Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12 | Burning/Stinging Score, Week 4 | -0.02 Score on scale | Standard Deviation 0.43 |
| GSK2585823 Once Daily | Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12 | Burning/Stinging Score, Week 8 | -0.02 Score on scale | Standard Deviation 0.44 |
| GSK2585823 Once Daily | Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12 | Burning/Stinging Score, Week 12 | -0.06 Score on scale | Standard Deviation 0.38 |
| GSK2585823 Twice Daily | Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12 | Burning/Stinging Score, Week 8 | -0.04 Score on scale | Standard Deviation 0.47 |
| GSK2585823 Twice Daily | Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12 | Itching Score, Week 1 | 0.07 Score on scale | Standard Deviation 0.61 |
| GSK2585823 Twice Daily | Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12 | Burning/Stinging Score, Week 1 | 0.26 Score on scale | Standard Deviation 0.76 |
| GSK2585823 Twice Daily | Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12 | Itching Score, Week 12 | -0.08 Score on scale | Standard Deviation 0.53 |
| GSK2585823 Twice Daily | Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12 | Itching Score, Week 2 | 0.12 Score on scale | Standard Deviation 0.73 |
| GSK2585823 Twice Daily | Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12 | Burning/Stinging Score, Week 12 | -0.08 Score on scale | Standard Deviation 0.38 |
| GSK2585823 Twice Daily | Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12 | Burning/Stinging Score, Week 4 | -0.02 Score on scale | Standard Deviation 0.48 |
| GSK2585823 Twice Daily | Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12 | Itching Score, Week 4 | -0.02 Score on scale | Standard Deviation 0.48 |
| GSK2585823 Twice Daily | Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12 | Burning/Stinging Score, Week 2 | 0.11 Score on scale | Standard Deviation 0.61 |
| GSK2585823 Twice Daily | Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12 | Itching Score, Week 8 | -0.06 Score on scale | Standard Deviation 0.43 |
| CLDM Twice Daily | Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12 | Burning/Stinging Score, Week 4 | -0.07 Score on scale | Standard Deviation 0.39 |
| CLDM Twice Daily | Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12 | Itching Score, Week 8 | -0.14 Score on scale | Standard Deviation 0.55 |
| CLDM Twice Daily | Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12 | Itching Score, Week 12 | -0.12 Score on scale | Standard Deviation 0.52 |
| CLDM Twice Daily | Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12 | Burning/Stinging Score, Week 1 | -0.02 Score on scale | Standard Deviation 0.45 |
| CLDM Twice Daily | Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12 | Burning/Stinging Score, Week 8 | -0.08 Score on scale | Standard Deviation 0.39 |
| CLDM Twice Daily | Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12 | Burning/Stinging Score, Week 2 | -0.06 Score on scale | Standard Deviation 0.37 |
| CLDM Twice Daily | Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12 | Itching Score, Week 1 | -0.08 Score on scale | Standard Deviation 0.53 |
| CLDM Twice Daily | Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12 | Burning/Stinging Score, Week 12 | -0.08 Score on scale | Standard Deviation 0.37 |
| CLDM Twice Daily | Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12 | Itching Score, Week 2 | -0.13 Score on scale | Standard Deviation 0.48 |
| CLDM Twice Daily | Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12 | Itching Score, Week 4 | -0.14 Score on scale | Standard Deviation 0.51 |
Secondary
Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX)
MIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism). MIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism) for the susceptibility of clinical isolates (Propionibacterium acnes before and after application of the CLDM and NDFX was reported. MIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis.
Time frame: Baseline (Day 1) and Week12
Population: ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2585823 Once Daily | Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX) | CLDM,Baseline,MIC50 | 0.12 Micrograms/milliliter |
| GSK2585823 Once Daily | Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX) | CLDM,Baseline,MIC90 | 1 Micrograms/milliliter |
| GSK2585823 Once Daily | Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX) | CLDM, Week 12,MIC50 | 0.25 Micrograms/milliliter |
| GSK2585823 Once Daily | Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX) | CLDM, Week 12,MIC90 | 128 Micrograms/milliliter |
| GSK2585823 Once Daily | Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX) | NDFX,Baseline,MIC50 | 0.25 Micrograms/milliliter |
| GSK2585823 Once Daily | Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX) | NDFX,Baseline,MIC90 | 0.5 Micrograms/milliliter |
| GSK2585823 Once Daily | Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX) | NDFX, Week 12,MIC50 | 0.25 Micrograms/milliliter |
| GSK2585823 Once Daily | Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX) | NDFX, Week 12,MIC90 | 0.5 Micrograms/milliliter |
| GSK2585823 Twice Daily | Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX) | CLDM, Week 12,MIC50 | 0.5 Micrograms/milliliter |
| GSK2585823 Twice Daily | Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX) | NDFX, Week 12,MIC50 | 0.25 Micrograms/milliliter |
| GSK2585823 Twice Daily | Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX) | CLDM, Week 12,MIC90 | 128 Micrograms/milliliter |
| GSK2585823 Twice Daily | Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX) | NDFX,Baseline,MIC50 | 0.25 Micrograms/milliliter |
| GSK2585823 Twice Daily | Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX) | NDFX,Baseline,MIC90 | 0.5 Micrograms/milliliter |
| GSK2585823 Twice Daily | Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX) | CLDM,Baseline,MIC50 | 0.12 Micrograms/milliliter |
| GSK2585823 Twice Daily | Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX) | CLDM,Baseline,MIC90 | 4 Micrograms/milliliter |
| GSK2585823 Twice Daily | Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX) | NDFX, Week 12,MIC90 | 0.5 Micrograms/milliliter |
| CLDM Twice Daily | Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX) | CLDM, Week 12,MIC50 | 0.5 Micrograms/milliliter |
| CLDM Twice Daily | Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX) | CLDM,Baseline,MIC90 | 4 Micrograms/milliliter |
| CLDM Twice Daily | Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX) | CLDM,Baseline,MIC50 | 0.12 Micrograms/milliliter |
| CLDM Twice Daily | Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX) | CLDM, Week 12,MIC90 | 128 Micrograms/milliliter |
| CLDM Twice Daily | Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX) | NDFX, Week 12,MIC50 | 0.25 Micrograms/milliliter |
| CLDM Twice Daily | Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX) | NDFX,Baseline,MIC90 | 0.5 Micrograms/milliliter |
| CLDM Twice Daily | Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX) | NDFX,Baseline,MIC50 | 0.25 Micrograms/milliliter |
| CLDM Twice Daily | Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX) | NDFX, Week 12,MIC90 | 0.5 Micrograms/milliliter |
Secondary
Percentage of Participants Who Have a Reduction of at Least 50 Percent in Total Lesions
The percentage of participants who had reduction in total lesions (inflammatory and non-inflammatory) of at least 50 percent from Baseline at Weeks 1, 2, 4, 8, and 12 was measured.
Time frame: Baseline (Day 1) and Week 1, 2, 4, 8, and 12
Population: ITT population. Only those participants available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2585823 Once Daily | Percentage of Participants Who Have a Reduction of at Least 50 Percent in Total Lesions | Week 8 | 79 Percentage of participants |
| GSK2585823 Once Daily | Percentage of Participants Who Have a Reduction of at Least 50 Percent in Total Lesions | Week 4 | 63 Percentage of participants |
| GSK2585823 Once Daily | Percentage of Participants Who Have a Reduction of at Least 50 Percent in Total Lesions | Week 1 | 18 Percentage of participants |
| GSK2585823 Once Daily | Percentage of Participants Who Have a Reduction of at Least 50 Percent in Total Lesions | Week 2 | 47 Percentage of participants |
| GSK2585823 Once Daily | Percentage of Participants Who Have a Reduction of at Least 50 Percent in Total Lesions | Week 12 | 85 Percentage of participants |
| GSK2585823 Twice Daily | Percentage of Participants Who Have a Reduction of at Least 50 Percent in Total Lesions | Week 4 | 71 Percentage of participants |
| GSK2585823 Twice Daily | Percentage of Participants Who Have a Reduction of at Least 50 Percent in Total Lesions | Week 1 | 24 Percentage of participants |
| GSK2585823 Twice Daily | Percentage of Participants Who Have a Reduction of at Least 50 Percent in Total Lesions | Week 2 | 51 Percentage of participants |
| GSK2585823 Twice Daily | Percentage of Participants Who Have a Reduction of at Least 50 Percent in Total Lesions | Week 8 | 82 Percentage of participants |
| GSK2585823 Twice Daily | Percentage of Participants Who Have a Reduction of at Least 50 Percent in Total Lesions | Week 12 | 89 Percentage of participants |
| CLDM Twice Daily | Percentage of Participants Who Have a Reduction of at Least 50 Percent in Total Lesions | Week 12 | 79 Percentage of participants |
| CLDM Twice Daily | Percentage of Participants Who Have a Reduction of at Least 50 Percent in Total Lesions | Week 8 | 69 Percentage of participants |
| CLDM Twice Daily | Percentage of Participants Who Have a Reduction of at Least 50 Percent in Total Lesions | Week 1 | 15 Percentage of participants |
| CLDM Twice Daily | Percentage of Participants Who Have a Reduction of at Least 50 Percent in Total Lesions | Week 4 | 52 Percentage of participants |
| CLDM Twice Daily | Percentage of Participants Who Have a Reduction of at Least 50 Percent in Total Lesions | Week 2 | 32 Percentage of participants |
Comparison: Comparison of GSK2585823 twice daily and CLDM twice daily at Week 1p-value: 0.002Cochran-Mantel-Haenszel
Comparison: Comparison of GSK2585823 twice daily and CLDM twice daily at Week 2p-value: <0.001Cochran-Mantel-Haenszel
Comparison: Comparison of GSK2585823 twice daily and CLDM twice daily at Week 4p-value: <0.001Cochran-Mantel-Haenszel
Comparison: Comparison of GSK2585823 twice daily and CLDM twice daily at Week 8p-value: <0.001Cochran-Mantel-Haenszel
Comparison: Comparison of GSK2585823 twice daily and CLDM twice daily at Week 12p-value: <0.001Cochran-Mantel-Haenszel
Comparison: Comparison of GSK2585823 once daily and CLDM twice daily at Week 1p-value: 0.48Cochran-Mantel-Haenszel
Comparison: Comparison of GSK2585823 once daily and CLDM twice daily at Week 2p-value: <0.001Cochran-Mantel-Haenszel
Comparison: Comparison of GSK2585823 once daily and CLDM twice daily at Week 4p-value: 0.009Cochran-Mantel-Haenszel
Comparison: Comparison of GSK2585823 once daily and CLDM twice daily at Week 8p-value: 0.008Cochran-Mantel-Haenszel
Comparison: Comparison of GSK2585823 once daily and CLDM twice daily at Week 12p-value: 0.065Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With a Minimum 2-grade Improvement From Baseline to Week 12 in Investigator's Static Global Assessment (ISGA) Score
Proportion of participants with at least a 2-Grade Improvement in ISGA was reported using a 5 point scale which indicates Score 0 (Clear): skin with no inflammatory or non-inflammatory lesions, Score 1 (Almost Clear): rare non-inflammatory lesions with no more than rare papules, Score 2 (Mild): greater than Grade 1, some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions), Score 3 (Moderate): greater than Grade 2, many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion, Score 4 (Severe): greater than Grade 3, many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions and 5(very severe): many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions. The investigator assessed ISGA score at baseline (Week 0/Day 1) and Weeks 1, 2, 4, 8, and 12. The area evaluated ISGA was limited to the face.
Time frame: Baseline (Day 1) and Week 12
Population: ITT population. Only those participants available at the indicated time points were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK2585823 Once Daily | Percentage of Participants With a Minimum 2-grade Improvement From Baseline to Week 12 in Investigator's Static Global Assessment (ISGA) Score | 30 Percentage of Participants |
| GSK2585823 Twice Daily | Percentage of Participants With a Minimum 2-grade Improvement From Baseline to Week 12 in Investigator's Static Global Assessment (ISGA) Score | 31 Percentage of Participants |
| CLDM Twice Daily | Percentage of Participants With a Minimum 2-grade Improvement From Baseline to Week 12 in Investigator's Static Global Assessment (ISGA) Score | 14 Percentage of Participants |
p-value: <0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With an ISGA Score of 0 (Clear) or 1 (Almost Clear) at Weeks 1, 2, 4, 8, and 12
Proportion of participants with at least a 2-Grade Improvement in ISGA was reported using a 5 point scale which indicates Score 0 (Clear): skin with no inflammatory or non-inflammatory lesions, Score 1 (Almost Clear): rare non-inflammatory lesions with no more than rare papules, Score 2 (Mild): greater than Grade 1, some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions), Score 3 (Moderate): greater than Grade 2, many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion, Score 4 (Severe): greater than Grade 3, many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions and 5 (very severe): many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions. The investigator assessed ISGA score at baseline (Week 0/Day 1) and Weeks 1, 2, 4, 8, and 12. The area evaluated ISGA was limited to the face.
Time frame: Week 1, 2, 4, 8, and 12
Population: ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2585823 Once Daily | Percentage of Participants With an ISGA Score of 0 (Clear) or 1 (Almost Clear) at Weeks 1, 2, 4, 8, and 12 | Week 8 | 22 Percentage of participants |
| GSK2585823 Once Daily | Percentage of Participants With an ISGA Score of 0 (Clear) or 1 (Almost Clear) at Weeks 1, 2, 4, 8, and 12 | Week 4 | 11 Percentage of participants |
| GSK2585823 Once Daily | Percentage of Participants With an ISGA Score of 0 (Clear) or 1 (Almost Clear) at Weeks 1, 2, 4, 8, and 12 | Week 1 | 2 Percentage of participants |
| GSK2585823 Once Daily | Percentage of Participants With an ISGA Score of 0 (Clear) or 1 (Almost Clear) at Weeks 1, 2, 4, 8, and 12 | Week 2 | 7 Percentage of participants |
| GSK2585823 Once Daily | Percentage of Participants With an ISGA Score of 0 (Clear) or 1 (Almost Clear) at Weeks 1, 2, 4, 8, and 12 | Week 12 | 30 Percentage of participants |
| GSK2585823 Twice Daily | Percentage of Participants With an ISGA Score of 0 (Clear) or 1 (Almost Clear) at Weeks 1, 2, 4, 8, and 12 | Week 4 | 13 Percentage of participants |
| GSK2585823 Twice Daily | Percentage of Participants With an ISGA Score of 0 (Clear) or 1 (Almost Clear) at Weeks 1, 2, 4, 8, and 12 | Week 1 | 2 Percentage of participants |
| GSK2585823 Twice Daily | Percentage of Participants With an ISGA Score of 0 (Clear) or 1 (Almost Clear) at Weeks 1, 2, 4, 8, and 12 | Week 2 | 5 Percentage of participants |
| GSK2585823 Twice Daily | Percentage of Participants With an ISGA Score of 0 (Clear) or 1 (Almost Clear) at Weeks 1, 2, 4, 8, and 12 | Week 8 | 20 Percentage of participants |
| GSK2585823 Twice Daily | Percentage of Participants With an ISGA Score of 0 (Clear) or 1 (Almost Clear) at Weeks 1, 2, 4, 8, and 12 | Week 12 | 34 Percentage of participants |
| CLDM Twice Daily | Percentage of Participants With an ISGA Score of 0 (Clear) or 1 (Almost Clear) at Weeks 1, 2, 4, 8, and 12 | Week 12 | 20 Percentage of participants |
| CLDM Twice Daily | Percentage of Participants With an ISGA Score of 0 (Clear) or 1 (Almost Clear) at Weeks 1, 2, 4, 8, and 12 | Week 8 | 9 Percentage of participants |
| CLDM Twice Daily | Percentage of Participants With an ISGA Score of 0 (Clear) or 1 (Almost Clear) at Weeks 1, 2, 4, 8, and 12 | Week 1 | 1 Percentage of participants |
| CLDM Twice Daily | Percentage of Participants With an ISGA Score of 0 (Clear) or 1 (Almost Clear) at Weeks 1, 2, 4, 8, and 12 | Week 4 | 7 Percentage of participants |
| CLDM Twice Daily | Percentage of Participants With an ISGA Score of 0 (Clear) or 1 (Almost Clear) at Weeks 1, 2, 4, 8, and 12 | Week 2 | 5 Percentage of participants |
Comparison: Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 1p-value: 0.47Cochran-Mantel-Haenszel
Comparison: Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 2p-value: 0.844Cochran-Mantel-Haenszel
Comparison: Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 4p-value: 0.022Cochran-Mantel-Haenszel
Comparison: Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 8p-value: <0.001Cochran-Mantel-Haenszel
Comparison: Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 12p-value: <0.001Cochran-Mantel-Haenszel
Comparison: Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 1p-value: 0.572Cochran-Mantel-Haenszel
Comparison: Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 2p-value: 0.335Cochran-Mantel-Haenszel
Comparison: Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 4p-value: 0.187Cochran-Mantel-Haenszel
Comparison: Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 8p-value: <0.001Cochran-Mantel-Haenszel
Comparison: Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 12p-value: 0.006Cochran-Mantel-Haenszel
Secondary
Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts
The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from value at indicated time points.( Weeks 1, 2, 4, 8 and 12)
Time frame: Baseline (Day 1) and Weeks 1, 2, 4, 8, and 12
Population: ITT population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2585823 Once Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Inflammatory lesions, Week 1 | -41.87 Percent change | Standard Error 1.885 |
| GSK2585823 Once Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Total lesions,Week 4 | -57.15 Percent change | Standard Error 1.848 |
| GSK2585823 Once Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Non-Inflammatory lesions, Week 1 | -26.49 Percent change | Standard Error 1.846 |
| GSK2585823 Once Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Inflammatory lesions, Week 2 | -55.64 Percent change | Standard Error 2.277 |
| GSK2585823 Once Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Total lesions,Week 2 | -46.87 Percent change | Standard Error 1.953 |
| GSK2585823 Once Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Inflammatory lesions, Week 12 | -80.84 Percent change | Standard Error 2.12 |
| GSK2585823 Once Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Inflammatory lesions, Week 4 | -66.51 Percent change | Standard Error 2.181 |
| GSK2585823 Once Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Non-Inflammatory lesions, Week 4 | -51.12 Percent change | Standard Error 2.246 |
| GSK2585823 Once Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Inflammatory lesions, Week 8 | -74.86 Percent change | Standard Error 2.256 |
| GSK2585823 Once Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Total lesions,Week 8 | -66.33 Percent change | Standard Error 1.935 |
| GSK2585823 Once Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Non-Inflammatory lesions, Week 12 | -69.01 Percent change | Standard Error 2.219 |
| GSK2585823 Once Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Total lesions,Week 1 | -32.42 Percent change | Standard Error 1.478 |
| GSK2585823 Once Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Total lesions,Week 12 | -73.85 Percent change | Standard Error 1.929 |
| GSK2585823 Once Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Non-Inflammatory lesions, Week 8 | -60.59 Percent change | Standard Error 2.247 |
| GSK2585823 Once Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Non-Inflammatory lesions, Week 2 | -41.26 Percent change | Standard Error 2.392 |
| GSK2585823 Twice Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Non-Inflammatory lesions, Week 2 | -43.43 Percent change | Standard Error 2.022 |
| GSK2585823 Twice Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Total lesions,Week 1 | -33.29 Percent change | Standard Error 1.312 |
| GSK2585823 Twice Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Total lesions,Week 2 | -49.29 Percent change | Standard Error 1.544 |
| GSK2585823 Twice Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Total lesions,Week 4 | -59.98 Percent change | Standard Error 1.454 |
| GSK2585823 Twice Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Total lesions,Week 8 | -68.49 Percent change | Standard Error 1.551 |
| GSK2585823 Twice Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Total lesions,Week 12 | -75.57 Percent change | Standard Error 1.512 |
| GSK2585823 Twice Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Inflammatory lesions, Week 1 | -39.76 Percent change | Standard Error 1.704 |
| GSK2585823 Twice Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Inflammatory lesions, Week 2 | -58.31 Percent change | Standard Error 1.641 |
| GSK2585823 Twice Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Inflammatory lesions, Week 4 | -66.89 Percent change | Standard Error 1.617 |
| GSK2585823 Twice Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Inflammatory lesions, Week 8 | -74.37 Percent change | Standard Error 1.75 |
| GSK2585823 Twice Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Inflammatory lesions, Week 12 | -81.14 Percent change | Standard Error 1.598 |
| GSK2585823 Twice Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Non-Inflammatory lesions, Week 1 | -29.20 Percent change | Standard Error 1.697 |
| GSK2585823 Twice Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Non-Inflammatory lesions, Week 4 | -55.40 Percent change | Standard Error 1.847 |
| GSK2585823 Twice Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Non-Inflammatory lesions, Week 8 | -64.83 Percent change | Standard Error 1.844 |
| GSK2585823 Twice Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Non-Inflammatory lesions, Week 12 | -71.90 Percent change | Standard Error 1.804 |
| CLDM Twice Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Inflammatory lesions, Week 1 | -31.32 Percent change | Standard Error 1.59 |
| CLDM Twice Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Non-Inflammatory lesions, Week 8 | -51.75 Percent change | Standard Error 1.892 |
| CLDM Twice Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Non-Inflammatory lesions, Week 1 | -20.69 Percent change | Standard Error 1.558 |
| CLDM Twice Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Total lesions,Week 12 | -64.42 Percent change | Standard Error 1.625 |
| CLDM Twice Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Total lesions,Week 8 | -57.20 Percent change | Standard Error 1.63 |
| CLDM Twice Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Non-Inflammatory lesions, Week 2 | -32.96 Percent change | Standard Error 2.014 |
| CLDM Twice Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Total lesions,Week 4 | -48.26 Percent change | Standard Error 1.556 |
| CLDM Twice Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Total lesions,Week 1 | -24.71 Percent change | Standard Error 1.247 |
| CLDM Twice Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Non-Inflammatory lesions, Week 4 | -41.85 Percent change | Standard Error 1.891 |
| CLDM Twice Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Inflammatory lesions, Week 4 | -58.87 Percent change | Standard Error 1.837 |
| CLDM Twice Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Total lesions,Week 2 | -38.36 Percent change | Standard Error 1.644 |
| CLDM Twice Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Inflammatory lesions, Week 8 | -66.13 Percent change | Standard Error 1.899 |
| CLDM Twice Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Inflammatory lesions, Week 2 | -48.43 Percent change | Standard Error 1.917 |
| CLDM Twice Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Non-Inflammatory lesions, Week 12 | -59.33 Percent change | Standard Error 1.869 |
| CLDM Twice Daily | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | Inflammatory lesions, Week 12 | -72.64 Percent change | Standard Error 1.785 |
Comparison: Total Lesion Counts, WEEK 1p-value: <0.00195% CI: [-11.3, -4.12]ANCOVA
Comparison: Total Lesion Counts, WEEK 2p-value: <0.00195% CI: [-13.24, -3.77]ANCOVA
Comparison: Total Lesion Counts, WEEK 4p-value: <0.00195% CI: [-13.37, -4.41]ANCOVA
Comparison: Total Lesion Counts, WEEK 8p-value: <0.00195% CI: [-13.82, -4.43]ANCOVA
Comparison: Total Lesion Counts, WEEK 12p-value: <0.00195% CI: [-14.11, -4.75]ANCOVA
Comparison: Inflammatory Lesion Counts, WEEK 1p-value: <0.00195% CI: [-15.12, -5.97]ANCOVA
Comparison: Inflammatory Lesion Counts, WEEK 2p-value: 0.01195% CI: [-12.73, -1.69]ANCOVA
Comparison: Inflammatory Lesion Counts, WEEK 4p-value: 0.00595% CI: [-12.93, -2.35]ANCOVA
Comparison: Inflammatory Lesion Counts, WEEK 8p-value: 0.00295% CI: [-14.2, -3.26]ANCOVA
Comparison: Inflammatory Lesion Counts, WEEK 12p-value: 0.00295% CI: [-13.34, -3.06]ANCOVA
Comparison: Non-Inflammatory Lesion Counts, WEEK 1p-value: 0.01195% CI: [-10.29, -1.32]ANCOVA
Comparison: Non-Inflammatory Lesion Counts, WEEK 2p-value: 0.00595% CI: [-14.1, -2.5]ANCOVA
Comparison: Non-Inflammatory Lesion Counts, WEEK 4p-value: <0.00195% CI: [-14.72, -3.83]ANCOVA
Comparison: Non-Inflammatory Lesion Counts, WEEK 8p-value: 0.00295% CI: [-14.28, -3.39]ANCOVA
Comparison: Non-Inflammatory Lesion Counts, WEEK 12p-value: <0.00195% CI: [-15.06, -4.3]ANCOVA
Comparison: Total Lesion Counts, WEEK 1p-value: <0.00195% CI: [-12.32, -5.48]ANCOVA
Comparison: Total Lesion Counts, WEEK 2p-value: <0.00195% CI: [-15.18, -7.16]ANCOVA
Comparison: Total Lesion Counts, WEEK 4p-value: <0.00195% CI: [-15.9, -8.35]ANCOVA
Comparison: Total Lesion Counts, WEEK 8p-value: <0.00195% CI: [-15.37, -7.3]ANCOVA
Comparison: Total Lesion Counts, WEEK 12p-value: <0.00195% CI: [-15.11, -7.25]ANCOVA
Comparison: Inflammatory Lesion Counts, WEEK 1p-value: <0.00195% CI: [-12.76, -3.88]ANCOVA
Comparison: Inflammatory Lesion Counts, WEEK 2p-value: <0.00195% CI: [-13.83, -5.3]ANCOVA
Comparison: Inflammatory Lesion Counts, WEEK 4p-value: <0.00195% CI: [-12.03, -3.62]ANCOVA
Comparison: Inflammatory Lesion Counts, WEEK 8p-value: <0.00195% CI: [-12.63, -3.53]ANCOVA
Comparison: Inflammatory Lesion Counts, WEEK 12p-value: <0.00195% CI: [-12.71, -4.41]ANCOVA
Comparison: Non-Inflammatory Lesion Counts, WEEK 1p-value: <0.00195% CI: [-13.53, -4.68]ANCOVA
Comparison: Non-Inflammatory Lesion Counts, WEEK 2p-value: <0.00195% CI: [-16.3, -5.8]ANCOVA
Comparison: Non-Inflammatory Lesion Counts, WEEK 4p-value: <0.00195% CI: [-18.97, -9.37]ANCOVA
Comparison: Non-Inflammatory Lesion Counts, WEEK 8p-value: <0.00195% CI: [-17.83, -8.25]ANCOVA
Comparison: Non-Inflammatory Lesion Counts, WEEK 12p-value: <0.00195% CI: [-17.05, -7.68]ANCOVA