Acne
Conditions
Keywords
Acne Vulgaris, Acne
Brief summary
The purpose of the study is to determine the development of microbial resistance when using one of two topical acne therapies for the treatment of facial acne vulgaris.
Detailed description
To investigate the development of microbial resistance when using one of two topical acne therapies for the treatment of moderate to moderately severe facial acne vulgaris. Clinical efficacy and tolerability will be assessed.
Interventions
DRUGDuac
Clindamycon and benzoyl peroxide topical gel once a day for 12 weeks
DRUGZiana gel
Clindamycin and tretinoin gel once a day for 12 weeks.
Sponsors
GlaxoSmithKline
Stiefel, a GSK Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Outpatient at least 12 years of age. Female subjects of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study. * Mild to moderate facial acne vulgaris * Able to understand the requirements of the study and sign informed consent/HIPAA authorization forms. Subjects under the legal age of consent in the state where the study is conducted must also have the written, informed consent of a parent or legal guardian.
Exclusion criteria
* Female subjects who are pregnant (positive urine pregnancy test), breast feeding or who are of childbearing potential and not practicing a reliable method of birth control * Allergy or sensitivity to any component of the test medication * Known hypersensitivity to to any component of the investigational formulations * Known history of enteritis (regional enteritis, ulcerative colitis, pseudomembranous colitis, or antibiotic-associated colitis * Beards or sideburns * Skin disease/disorder that might interfere with the diagnosis or evaluation of acne vulgaris * Evidence of recent alcohol or drug abuse * Participation in an investigational drug study within 30 days of the baseline visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Change in Total Propionibacterium Acne (P.Acne) Counts | Baseline, Weeks 2, 4, 8, 12, & 16 | Median change in total colony forming units of propionibacterium acne (P.acne) will be counted. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Change in Clindamycin Resistant P. Acne. | Baseline, Weeks 2, 4, 8, 12, 16 | Median change in total colony forming units of clindamycin resistant p. acne. |
| Median Change in Erythromycin-resistant P. Acne Counts | Baseline, Weeks 2, 4, 8, 12, and 16 | Total colony forming units of erythromycin-resistant p. acnes. |
| Median Change in Total Acne Lesions | Baseline, Weeks 2, 4, 8, 12, and 16 | Median Change in Total Acne Lesions |
| Median Change in Inflammatory Acne Lesion Counts | Baseline, Weeks 2, 4, 8, 12, and 16 | Median Change in Inflammatory Acne Lesion Counts |
| Median Change in Noninflammaotry Acne Counts | Baseline, Weeks 2, 4, 8, 12, and 16 | Median Change in Noninflammaotry Acne Counts |
Countries
United States
Participant flow
Recruitment details
Clinical research center
Participants by arm
| Arm | Count |
|---|---|
| Duac Clindamycin and benzoyl peroxide topical gel | 27 |
| Ziana Clindamycin and topical tretinoin gel | 27 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Duac | Ziana | Total |
|---|---|---|---|
| Acne Lesion Counts Inflammatory Lesion Counts | 24.74 Acne Lesion Counts STANDARD_DEVIATION 10.61 | 22.78 Acne Lesion Counts STANDARD_DEVIATION 7.07 | 23.76 Acne Lesion Counts STANDARD_DEVIATION 8.98 |
| Acne Lesion Counts Noninflammatory Lesion Counts | 34.30 Acne Lesion Counts STANDARD_DEVIATION 20.38 | 35.11 Acne Lesion Counts STANDARD_DEVIATION 15.4 | 34.70 Acne Lesion Counts STANDARD_DEVIATION 17.9 |
| Acne Lesion Counts Total Lesion Counts | 59.04 Acne Lesion Counts STANDARD_DEVIATION 23.68 | 57.89 Acne Lesion Counts STANDARD_DEVIATION 19.99 | 58.46 Acne Lesion Counts STANDARD_DEVIATION 21.72 |
| Age, Continuous | 17.6 years STANDARD_DEVIATION 6.9 | 16.2 years STANDARD_DEVIATION 4.9 | 16.9 years STANDARD_DEVIATION 6 |
| Clinidamycin-resistant propionibacterium acne (P.acne) counts | 2.29 Clinidamycin-resistant p. acne counts STANDARD_DEVIATION 1.34 | 2.02 Clinidamycin-resistant p. acne counts STANDARD_DEVIATION 1.21 | 2.16 Clinidamycin-resistant p. acne counts STANDARD_DEVIATION 1.27 |
| Erythromycin-resistant lesion count | 2.29 Erythromycin-resistant lesion count STANDARD_DEVIATION 1.37 | 1.92 Erythromycin-resistant lesion count STANDARD_DEVIATION 1.11 | 2.10 Erythromycin-resistant lesion count STANDARD_DEVIATION 1.25 |
| Propionibacterium acne counts | 4.63 P. acne counts STANDARD_DEVIATION 1.12 | 4.74 P. acne counts STANDARD_DEVIATION 0.58 | 4.69 P. acne counts STANDARD_DEVIATION 0.88 |
| Race/Ethnicity, Customized Black | 4 Participants | 4 Participants | 8 Participants |
| Race/Ethnicity, Customized Caucasian | 21 Participants | 22 Participants | 43 Participants |
| Race/Ethnicity, Customized Hispanic | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 0 Participants | 2 Participants |
| Region of Enrollment United States | 27 participants | 27 participants | 54 participants |
| Sex: Female, Male Female | 14 Participants | 15 Participants | 29 Participants |
| Sex: Female, Male Male | 13 Participants | 12 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 27 | 5 / 27 |
| serious Total, serious adverse events | 0 / 27 | 0 / 27 |
Outcome results
Primary
Median Change in Total Propionibacterium Acne (P.Acne) Counts
Median change in total colony forming units of propionibacterium acne (P.acne) will be counted.
Time frame: Baseline, Weeks 2, 4, 8, 12, & 16
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Duac | Median Change in Total Propionibacterium Acne (P.Acne) Counts | Change from Baseline to Week 12 | -1.82 P. acne counts | Inter-Quartile Range 1.6 |
| Duac | Median Change in Total Propionibacterium Acne (P.Acne) Counts | Change from Baseline to Week 2 | -1.26 P. acne counts | Inter-Quartile Range 1.44 |
| Duac | Median Change in Total Propionibacterium Acne (P.Acne) Counts | Change from Baseline to Week 16 | -2.48 P. acne counts | Inter-Quartile Range 1.77 |
| Duac | Median Change in Total Propionibacterium Acne (P.Acne) Counts | Change from Baseline to Week 4 | -1.58 P. acne counts | Inter-Quartile Range 1.49 |
| Duac | Median Change in Total Propionibacterium Acne (P.Acne) Counts | Change from Baseline to Week 8 | -1.65 P. acne counts | Inter-Quartile Range 1.5 |
| Ziana | Median Change in Total Propionibacterium Acne (P.Acne) Counts | Change from Baseline to Week 4 | -0.67 P. acne counts | Inter-Quartile Range 1.18 |
| Ziana | Median Change in Total Propionibacterium Acne (P.Acne) Counts | Change from Baseline to Week 8 | -0.32 P. acne counts | Inter-Quartile Range 1.04 |
| Ziana | Median Change in Total Propionibacterium Acne (P.Acne) Counts | Change from Baseline to Week 12 | -0.59 P. acne counts | Inter-Quartile Range 0.99 |
| Ziana | Median Change in Total Propionibacterium Acne (P.Acne) Counts | Change from Baseline to Week 16 | -0.57 P. acne counts | Inter-Quartile Range 0.83 |
| Ziana | Median Change in Total Propionibacterium Acne (P.Acne) Counts | Change from Baseline to Week 2 | -0.08 P. acne counts | Inter-Quartile Range 0.82 |
Secondary
Median Change in Clindamycin Resistant P. Acne.
Median change in total colony forming units of clindamycin resistant p. acne.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16
Population: ITT
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Duac | Median Change in Clindamycin Resistant P. Acne. | Change from Baseline to Week 2 | -0.30 Clindamycin- resistant P. acne counts |
| Duac | Median Change in Clindamycin Resistant P. Acne. | Change from Baseline to Week 4 | 0 Clindamycin- resistant P. acne counts |
| Duac | Median Change in Clindamycin Resistant P. Acne. | Change from Baseline to Week 8 | -0.86 Clindamycin- resistant P. acne counts |
| Duac | Median Change in Clindamycin Resistant P. Acne. | Change from Baseline to Week 12 | -0.83 Clindamycin- resistant P. acne counts |
| Duac | Median Change in Clindamycin Resistant P. Acne. | Change from Baseline to Week 16 | -0.30 Clindamycin- resistant P. acne counts |
| Ziana | Median Change in Clindamycin Resistant P. Acne. | Change from Baseline to Week 16 | 0 Clindamycin- resistant P. acne counts |
| Ziana | Median Change in Clindamycin Resistant P. Acne. | Change from Baseline to Week 2 | 0 Clindamycin- resistant P. acne counts |
| Ziana | Median Change in Clindamycin Resistant P. Acne. | Change from Baseline to Week 4 | 0 Clindamycin- resistant P. acne counts |
| Ziana | Median Change in Clindamycin Resistant P. Acne. | Change from Baseline to Week 12 | 0.39 Clindamycin- resistant P. acne counts |
| Ziana | Median Change in Clindamycin Resistant P. Acne. | Change from Baseline to Week 8 | 0 Clindamycin- resistant P. acne counts |
Secondary
Median Change in Erythromycin-resistant P. Acne Counts
Total colony forming units of erythromycin-resistant p. acnes.
Time frame: Baseline, Weeks 2, 4, 8, 12, and 16
Population: ITT
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Duac | Median Change in Erythromycin-resistant P. Acne Counts | Change from Baseline to Week 4 | -0.18 Erythromycin-resistant P. acne counts |
| Duac | Median Change in Erythromycin-resistant P. Acne Counts | Change from Baseline to Week 12 | -.91 Erythromycin-resistant P. acne counts |
| Duac | Median Change in Erythromycin-resistant P. Acne Counts | Change from Baseline to Week 8 | -0.83 Erythromycin-resistant P. acne counts |
| Duac | Median Change in Erythromycin-resistant P. Acne Counts | Change from Baseline to Week 16 | 0 Erythromycin-resistant P. acne counts |
| Duac | Median Change in Erythromycin-resistant P. Acne Counts | Change from Baseline to Week 2 | -0.36 Erythromycin-resistant P. acne counts |
| Ziana | Median Change in Erythromycin-resistant P. Acne Counts | Change from Baseline to Week 16 | 0.04 Erythromycin-resistant P. acne counts |
| Ziana | Median Change in Erythromycin-resistant P. Acne Counts | Change from Baseline to Week 2 | 0 Erythromycin-resistant P. acne counts |
| Ziana | Median Change in Erythromycin-resistant P. Acne Counts | Change from Baseline to Week 4 | 0 Erythromycin-resistant P. acne counts |
| Ziana | Median Change in Erythromycin-resistant P. Acne Counts | Change from Baseline to Week 8 | 0 Erythromycin-resistant P. acne counts |
| Ziana | Median Change in Erythromycin-resistant P. Acne Counts | Change from Baseline to Week 12 | 0.15 Erythromycin-resistant P. acne counts |
Secondary
Median Change in Inflammatory Acne Lesion Counts
Median Change in Inflammatory Acne Lesion Counts
Time frame: Baseline, Weeks 2, 4, 8, 12, and 16
Population: ITT
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Duac | Median Change in Inflammatory Acne Lesion Counts | Change from Baseline to Week 16 | -14 Lesion Counts |
| Duac | Median Change in Inflammatory Acne Lesion Counts | Change from Baseline to Week 2 | -7 Lesion Counts |
| Duac | Median Change in Inflammatory Acne Lesion Counts | Change from Baseline to Week 4 | -12 Lesion Counts |
| Duac | Median Change in Inflammatory Acne Lesion Counts | Change from Baseline to Week 8 | -11 Lesion Counts |
| Duac | Median Change in Inflammatory Acne Lesion Counts | Change from Baseline to Week 12 | -12.5 Lesion Counts |
| Ziana | Median Change in Inflammatory Acne Lesion Counts | Change from Baseline to Week 12 | -10.5 Lesion Counts |
| Ziana | Median Change in Inflammatory Acne Lesion Counts | Change from Baseline to Week 8 | -7 Lesion Counts |
| Ziana | Median Change in Inflammatory Acne Lesion Counts | Change from Baseline to Week 2 | -7 Lesion Counts |
| Ziana | Median Change in Inflammatory Acne Lesion Counts | Change from Baseline to Week 16 | -14 Lesion Counts |
| Ziana | Median Change in Inflammatory Acne Lesion Counts | Change from Baseline to Week 4 | -7 Lesion Counts |
Secondary
Median Change in Noninflammaotry Acne Counts
Median Change in Noninflammaotry Acne Counts
Time frame: Baseline, Weeks 2, 4, 8, 12, and 16
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Duac | Median Change in Noninflammaotry Acne Counts | Change from Baseline to Week 4 | -10 Noninflammatory lesion counts |
| Duac | Median Change in Noninflammaotry Acne Counts | Change from Baseline to Week 12 | -9 Noninflammatory lesion counts |
| Duac | Median Change in Noninflammaotry Acne Counts | Change from Baseline to Week 8 | -13 Noninflammatory lesion counts |
| Duac | Median Change in Noninflammaotry Acne Counts | Change from Baseline to Week 16 | -11 Noninflammatory lesion counts |
| Duac | Median Change in Noninflammaotry Acne Counts | Change from Baseline to Week 2 | -6 Noninflammatory lesion counts |
| Ziana | Median Change in Noninflammaotry Acne Counts | Change from Baseline to Week 16 | -16.5 Noninflammatory lesion counts |
| Ziana | Median Change in Noninflammaotry Acne Counts | Change from Baseline to Week 2 | -6 Noninflammatory lesion counts |
| Ziana | Median Change in Noninflammaotry Acne Counts | Change from Baseline to Week 4 | -8 Noninflammatory lesion counts |
| Ziana | Median Change in Noninflammaotry Acne Counts | Change from Baseline to Week 8 | -12 Noninflammatory lesion counts |
| Ziana | Median Change in Noninflammaotry Acne Counts | Change from Baseline to Week 12 | -13.5 Noninflammatory lesion counts |
Secondary
Median Change in Total Acne Lesions
Median Change in Total Acne Lesions
Time frame: Baseline, Weeks 2, 4, 8, 12, and 16
Population: ITT
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Duac | Median Change in Total Acne Lesions | Change from Baseline to Week 8 | -27 Total Acne Lesion Counts |
| Duac | Median Change in Total Acne Lesions | Change from Baseline to Week 16 | -33 Total Acne Lesion Counts |
| Duac | Median Change in Total Acne Lesions | Change from Baseline to Week 12 | -26.5 Total Acne Lesion Counts |
| Duac | Median Change in Total Acne Lesions | Change from Baseline to Week 2 | -14 Total Acne Lesion Counts |
| Duac | Median Change in Total Acne Lesions | Change from Baseline to Week 4 | -22 Total Acne Lesion Counts |
| Ziana | Median Change in Total Acne Lesions | Change from Baseline to Week 2 | -13 Total Acne Lesion Counts |
| Ziana | Median Change in Total Acne Lesions | Change from Baseline to Week 4 | -14 Total Acne Lesion Counts |
| Ziana | Median Change in Total Acne Lesions | Change from Baseline to Week 8 | -19 Total Acne Lesion Counts |
| Ziana | Median Change in Total Acne Lesions | Change from Baseline to Week 12 | -23.5 Total Acne Lesion Counts |
| Ziana | Median Change in Total Acne Lesions | Change from Baseline to Week 16 | -30 Total Acne Lesion Counts |