Acne, Acne Vulgaris
Conditions
Keywords
Acne Vulgaris, Acne
Brief summary
The purpose of this study is to demonstrate the safety and effectiveness of CT Gel in subjects with acne vulgaris. The hypothesis is that CT Gel is superior to Clindamycin Gel, Tretinoin Gel and Vehicle Gel for the treatment of acne vulgaris.
Detailed description
CT Gel is a fixed-combination product that addresses the multifactorial factors of acne vulgaris pathogenesis. Based on numerous nonclinical pharmacology studies of each active ingredient, it is expected that this new product will have three biological actions: 1) comedolytic, 2) antimicrobial, and 3) anti-inflammatory.
Interventions
DRUGCT Gel
Topical gel consisting of clindamycin 1% and tretinoin 0.025%, applied once daily in the evening for 12 weeks
DRUGClindamycin Gel (clindamycin )
Clindamycin 1% gel applied topically once daily in the evening for 12 weeks
DRUGTretinoin Gel (tretinoin)
Tretinoin 0.025% gel applied topically once daily in the evening for 12 weeks
DRUGVehicle Gel
Topical gel without clindamycin or tretinoin applied topically once daily in the evening for 12 weeks
Sponsors
GlaxoSmithKline
Stiefel, a GSK Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female 12 years of age or older in good general health * Investigator's Static Global Assessment (ISGA) score of 2 or greater at Baseline
Exclusion criteria
* Any nodulo-cystic lesions at Baseline * Pregnancy or breast feeding * History or presence of regional enteritis or inflammatory bowel disease or similar symptoms. * Treatment with estrogens, including oral, implanted and topical contraceptives, androgens, or anti-androgenic agents for 12 weeks or less prior to study start. * Use of topical anti-acne medications within the past 2 weeks. * Use of topical or systemic antibiotics on the face within the past 2 weeks. * Use of topical or systemic corticosteroids within the past 2 weeks. * Use of systemic retinoids within the past 3 months. * Use of astringents, toners and skin cleansers for less than 2 weeks prior to the start of the study. * Concomitant use of facial product containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide or salicylic acid, non mild cleansers or moisturizers containing retinol, salicylic or α- or β-hydroxy acids. * Concomitant use of mega-doses of certain vitamins, such as vitamin D (\>2000IU QD) vitamin B12, haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital. * Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 2 weeks or during the study. * Concomitant use of tanning booths or sunbathing. * Known hypersensitivity or previous allergic reaction to any of the active components, lincomycin, retinoids or excipients of the study product * A significant medical history of or are currently immunocompromised * Current drug or alcohol abuse. (Drug screening not required.) * Use of any investigational therapy within 4 weeks of enrollment. * Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study) | Baseline, Week 12 | Acne lesion counts (inflammatory \[papules, pustules, nodules\], non-inflammatory \[open and closed comedones\], and total) were performed on the face of participants. Change from baseline is defined as Week 12 values minus Baseline values. The total lesion count is the sum of the inflammatory and non-inflammatory lesion counts. |
| The Percentage of Participants Who Had a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12 | Baseline, Week 12 | The ISGA is a static (snap-shot) evaluation of acne severity performed by an investigator/assessor at every visit. The ISGA score is measured on a 6-point ordinal scale, where 0=Clear and 5=Very Severe. Change is calculated as the Week 12 value minus the Baseline value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12 | Baseline, Week 12 | Acne lesion counts (inflammatory \[papules, pustules, nodules\], non-inflammatory \[open and closed comedones\], and total) were performed on the face of participants. Change from baseline is defined as Week 12 values minus Baseline values. The total lesion count is the sum of the inflammatory and non-inflammatory lesion counts. |
| The Percentage of Participants With a Subjects Global Assessment Score of 0 or 1 at Week 12 | Week 12 | The SGA score is a global evaluation of acne severity performed by participants at all visits and measured on a 5-point ordinal scale, where 0=My face is basically free of acne and 5=My face has blackheads and/or whiteheads. A score of 1=My face has several blackheads and/or whiteheads and small pimples, but there are no tender deep-seated bumps or cysts. |
| The Percentage of Participants Who Had ISGA Scores of 0 or 1 at Week 12 | Week 12 | The ISGA is a static (snap-shot) evaluation of acne severity performed by an investigator/assessor at every visit. The ISGA score is measured on a 6-point ordinal scale, where 0=Clear and 5=Very Severe. A score of 1=Skin Almost Clear: rare non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving and may be hyper-pigmented, though not pink-red) requiring no futher treatment in the Investigator's opinion. |
Countries
Belize, Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CT Gel Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks | 476 |
| Clindamycin Gel Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks | 467 |
| Tretinoin Gel Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks | 464 |
| Vehicle Gel Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks | 242 |
| Total | 1,649 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 6 | 0 | 5 | 0 |
| Overall Study | Change/Discontinuation of Birth Control | 1 | 1 | 1 | 0 |
| Overall Study | Dispensing Error | 0 | 1 | 0 | 0 |
| Overall Study | Fear of Birth Defects | 0 | 0 | 1 | 0 |
| Overall Study | Incarceration | 2 | 0 | 0 | 0 |
| Overall Study | Inclusion/Exclusion Criteria Not Met | 1 | 2 | 0 | 0 |
| Overall Study | Lack of Efficacy | 1 | 2 | 2 | 2 |
| Overall Study | Lost to Follow-up | 26 | 19 | 17 | 11 |
| Overall Study | Non-Compliance with Study Treatment | 3 | 3 | 3 | 1 |
| Overall Study | Non-compliance with Treatment Regimen | 0 | 1 | 0 | 0 |
| Overall Study | Patient Withdrew from Study | 0 | 0 | 0 | 1 |
| Overall Study | Personal Reason | 0 | 1 | 0 | 0 |
| Overall Study | Pregnancy | 0 | 2 | 0 | 2 |
| Overall Study | Transportation | 1 | 0 | 0 | 0 |
| Overall Study | Unable to Comply with Visit Schedule | 0 | 0 | 1 | 1 |
| Overall Study | Use of Prohibitive Medication | 2 | 1 | 3 | 0 |
| Overall Study | Withdrawal by Subject | 19 | 18 | 26 | 13 |
Baseline characteristics
| Characteristic | CT Gel | Clindamycin Gel | Tretinoin Gel | Vehicle Gel | Total |
|---|---|---|---|---|---|
| Age, Continuous | 20.8 years STANDARD_DEVIATION 8.5 | 20.2 years STANDARD_DEVIATION 8.1 | 20.2 years STANDARD_DEVIATION 7.7 | 20.6 years STANDARD_DEVIATION 8.4 | 20.4 years STANDARD_DEVIATION 8.1 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 4 participants | 4 participants | 4 participants | 3 participants | 15 participants |
| Race/Ethnicity, Customized Asian | 8 participants | 8 participants | 11 participants | 5 participants | 32 participants |
| Race/Ethnicity, Customized Black | 94 participants | 85 participants | 103 participants | 51 participants | 333 participants |
| Race/Ethnicity, Customized Missing | 0 participants | 1 participants | 1 participants | 1 participants | 3 participants |
| Race/Ethnicity, Customized Multiracial | 12 participants | 16 participants | 19 participants | 5 participants | 52 participants |
| Race/Ethnicity, Customized Native Hawaiian/Other Pacific Islander | 0 participants | 4 participants | 2 participants | 1 participants | 7 participants |
| Race/Ethnicity, Customized White | 358 participants | 349 participants | 324 participants | 176 participants | 1207 participants |
| Sex: Female, Male Female | 269 Participants | 266 Participants | 264 Participants | 153 Participants | 952 Participants |
| Sex: Female, Male Male | 207 Participants | 201 Participants | 200 Participants | 89 Participants | 697 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 27 / 476 | 34 / 467 | 27 / 464 | 18 / 242 |
| serious Total, serious adverse events | 1 / 476 | 1 / 467 | 3 / 464 | 1 / 242 |
Outcome results
Primary
Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study)
Acne lesion counts (inflammatory \[papules, pustules, nodules\], non-inflammatory \[open and closed comedones\], and total) were performed on the face of participants. Change from baseline is defined as Week 12 values minus Baseline values. The total lesion count is the sum of the inflammatory and non-inflammatory lesion counts.
Time frame: Baseline, Week 12
Population: Intent-to-Treat (ITT) Population: all participants who were randomized to and received at least one application of study product.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CT Gel | Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study) | Inflammatory Lesion Counts | -15.5 lesions | Standard Deviation 10.33 |
| CT Gel | Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study) | Non-Inflammatory Lesion Counts | -23.2 lesions | Standard Deviation 20.41 |
| CT Gel | Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study) | Total Lesion Counts | -38.7 lesions | Standard Deviation 26.8 |
| Clindamycin Gel | Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study) | Total Lesion Counts | -34.0 lesions | Standard Deviation 25.16 |
| Clindamycin Gel | Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study) | Non-Inflammatory Lesion Counts | -19.5 lesions | Standard Deviation 19.72 |
| Clindamycin Gel | Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study) | Inflammatory Lesion Counts | -14.5 lesions | Standard Deviation 9.37 |
| Tretinoin Gel | Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study) | Inflammatory Lesion Counts | -13.9 lesions | Standard Deviation 11.05 |
| Tretinoin Gel | Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study) | Non-Inflammatory Lesion Counts | -22.1 lesions | Standard Deviation 21.75 |
| Tretinoin Gel | Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study) | Total Lesion Counts | -36.0 lesions | Standard Deviation 28.26 |
| Vehicle Gel | Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study) | Total Lesion Counts | -28.1 lesions | Standard Deviation 27.26 |
| Vehicle Gel | Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study) | Non-Inflammatory Lesion Counts | -17.0 lesions | Standard Deviation 20.58 |
| Vehicle Gel | Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study) | Inflammatory Lesion Counts | -11.1 lesions | Standard Deviation 11.7 |
p-value: 0.063Ranked ANCOVA
p-value: 0.003Ranked ANCOVA
p-value: <0.001Ranked ANCOVA
p-value: 0.004Ranked ANCOVA
p-value: 0.55Ranked ANCOVA
p-value: <0.001Ranked ANCOVA
p-value: <0.001Ranked ANCOVA
p-value: 0.016Ranked ANCOVA
p-value: <0.001Ranked ANCOVA
Primary
The Percentage of Participants Who Had a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12
The ISGA is a static (snap-shot) evaluation of acne severity performed by an investigator/assessor at every visit. The ISGA score is measured on a 6-point ordinal scale, where 0=Clear and 5=Very Severe. Change is calculated as the Week 12 value minus the Baseline value.
Time frame: Baseline, Week 12
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CT Gel | The Percentage of Participants Who Had a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12 | 36.3 percentage of participants |
| Clindamycin Gel | The Percentage of Participants Who Had a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12 | 26.6 percentage of participants |
| Tretinoin Gel | The Percentage of Participants Who Had a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12 | 26.1 percentage of participants |
| Vehicle Gel | The Percentage of Participants Who Had a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12 | 20.2 percentage of participants |
p-value: 0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12
Acne lesion counts (inflammatory \[papules, pustules, nodules\], non-inflammatory \[open and closed comedones\], and total) were performed on the face of participants. Change from baseline is defined as Week 12 values minus Baseline values. The total lesion count is the sum of the inflammatory and non-inflammatory lesion counts.
Time frame: Baseline, Week 12
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CT Gel | Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12 | Inflammatory Lesions | -60.5 percent change | Standard Deviation 36.21 |
| CT Gel | Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12 | Non-Inflammatory Lesions | -51.1 percent change | Standard Deviation 33.02 |
| CT Gel | Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12 | Total Lesions | -55.0 percent change | Standard Deviation 30.47 |
| Clindamycin Gel | Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12 | Total Lesions | -49.0 percent change | Standard Deviation 30.08 |
| Clindamycin Gel | Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12 | Non-Inflammatory Lesions | -42.9 percent change | Standard Deviation 36.6 |
| Clindamycin Gel | Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12 | Inflammatory Lesions | -56.6 percent change | Standard Deviation 44.99 |
| Tretinoin Gel | Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12 | Inflammatory Lesions | -54.5 percent change | Standard Deviation 39.19 |
| Tretinoin Gel | Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12 | Total Lesions | -50.6 percent change | Standard Deviation 34.82 |
| Tretinoin Gel | Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12 | Non-Inflammatory Lesions | -47.3 percent change | Standard Deviation 43.5 |
| Vehicle Gel | Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12 | Total Lesions | -39.1 percent change | Standard Deviation 36.48 |
| Vehicle Gel | Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12 | Non-Inflammatory Lesions | -36.0 percent change | Standard Deviation 39.14 |
| Vehicle Gel | Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12 | Inflammatory Lesions | -43.3 percent change | Standard Deviation 44.9 |
p-value: 0.065Ranked ANCOVA
p-value: 0.002Ranked ANCOVA
p-value: <0.001Ranked ANCOVA
p-value: <0.001Ranked ANCOVA
p-value: 0.284Ranked ANCOVA
p-value: <0.001Ranked ANCOVA
p-value: <0.001Ranked ANCOVA
p-value: 0.028Ranked ANCOVA
p-value: <0.001Ranked ANCOVA
Secondary
The Percentage of Participants Who Had ISGA Scores of 0 or 1 at Week 12
The ISGA is a static (snap-shot) evaluation of acne severity performed by an investigator/assessor at every visit. The ISGA score is measured on a 6-point ordinal scale, where 0=Clear and 5=Very Severe. A score of 1=Skin Almost Clear: rare non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving and may be hyper-pigmented, though not pink-red) requiring no futher treatment in the Investigator's opinion.
Time frame: Week 12
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CT Gel | The Percentage of Participants Who Had ISGA Scores of 0 or 1 at Week 12 | 43.1 percentage of participants |
| Clindamycin Gel | The Percentage of Participants Who Had ISGA Scores of 0 or 1 at Week 12 | 36.6 percentage of participants |
| Tretinoin Gel | The Percentage of Participants Who Had ISGA Scores of 0 or 1 at Week 12 | 33.8 percentage of participants |
| Vehicle Gel | The Percentage of Participants Who Had ISGA Scores of 0 or 1 at Week 12 | 22.7 percentage of participants |
p-value: 0.002Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
Secondary
The Percentage of Participants With a Subjects Global Assessment Score of 0 or 1 at Week 12
The SGA score is a global evaluation of acne severity performed by participants at all visits and measured on a 5-point ordinal scale, where 0=My face is basically free of acne and 5=My face has blackheads and/or whiteheads. A score of 1=My face has several blackheads and/or whiteheads and small pimples, but there are no tender deep-seated bumps or cysts.
Time frame: Week 12
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CT Gel | The Percentage of Participants With a Subjects Global Assessment Score of 0 or 1 at Week 12 | 62 participants |
| Clindamycin Gel | The Percentage of Participants With a Subjects Global Assessment Score of 0 or 1 at Week 12 | 60 participants |
| Tretinoin Gel | The Percentage of Participants With a Subjects Global Assessment Score of 0 or 1 at Week 12 | 62 participants |
| Vehicle Gel | The Percentage of Participants With a Subjects Global Assessment Score of 0 or 1 at Week 12 | 50 participants |
p-value: 0.671Cochran-Mantel-Haenszel
p-value: 0.919Cochran-Mantel-Haenszel
p-value: 0.002Cochran-Mantel-Haenszel