A Phase 4 interventional study of Duac and Ziana gel in Acne, sponsored by Stiefel, a GSK Company. Completed at 2 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2017-05-25.
Sponsored by Stiefel, a GSK Company · Phase 4, Interventional, and Treatment
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.
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.
730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.
This study's enrollment of 54 is below the median of 69 across 628 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Stiefel, a GSK Company is the lead sponsor of 55 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Clindamycin and benzoyl peroxide gel
Drug: Duac
Clindamycin and tretinoin gel
Drug: Ziana gel
Clindamycon and benzoyl peroxide topical gel once a day for 12 weeks
Clindamycin and tretinoin gel once a day for 12 weeks.
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
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
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
Median Change in Total Acne Lesions
Median Change in Total Acne Lesions
Time frame: Baseline, Weeks 2, 4, 8, 12, and 16
Median Change in Inflammatory Acne Lesion Counts
Median Change in Inflammatory Acne Lesion Counts
Time frame: Baseline, Weeks 2, 4, 8, 12, and 16
Median Change in Noninflammaotry Acne Counts
Median Change in Noninflammaotry Acne Counts
Time frame: Baseline, Weeks 2, 4, 8, 12, and 16
Clinical research center
| Milestone | Duac | Ziana |
|---|---|---|
| Started | 27 | 27 |
| Completed | 25 | 24 |
| Not completed | 2 | 3 |
| Withdrew: Lack of efficacy | 0 | 1 |
| Withdrew: Lost to follow-up | 2 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
Median change in total colony forming units of propionibacterium acne (P.acne) will be counted.
| P. acne counts | Duac | Ziana |
|---|---|---|
| Change from Baseline to Week 2 | -1.26 ± 1.44 | -0.08 ± 0.82 |
| Change from Baseline to Week 4 | -1.58 ± 1.49 | -0.67 ± 1.18 |
| Change from Baseline to Week 8 | -1.65 ± 1.50 | -0.32 ± 1.04 |
| Change from Baseline to Week 12 | -1.82 ± 1.60 | -0.59 ± 0.99 |
| Change from Baseline to Week 16 | -2.48 ± 1.77 | -0.57 ± 0.83 |
Median change in total colony forming units of clindamycin resistant p. acne.
| Clindamycin- resistant P. acne counts | Duac | Ziana |
|---|---|---|
| Change from Baseline to Week 2 | -0.30 (-1.74 to 0) | 0 (0 to 0.4) |
| Change from Baseline to Week 4 | 0 (-1.43 to 0) | 0 (-0.51 to 0.12) |
| Change from Baseline to Week 8 | -0.86 (-1.95 to 0) | 0 (-0.10 to 0.60) |
| Change from Baseline to Week 12 | -0.83 (-1.53 to 0) | 0.39 (0 to 0.88) |
| Change from Baseline to Week 16 | -0.30 (-1.84 to 0) | 0 (-0.03 to 0.25) |
Total colony forming units of erythromycin-resistant p. acnes.
| Erythromycin-resistant P. acne counts | Duac | Ziana |
|---|---|---|
| Change from Baseline to Week 2 | -0.36 (-1.67 to 0) | 0 (0 to 0.56) |
| Change from Baseline to Week 4 | -0.18 (-1.51 to 0) | 0 (0 to 0.68) |
| Change from Baseline to Week 8 | -0.83 (-2.26 to 0) | 0 (0 to 0.40) |
| Change from Baseline to Week 12 | -.91 (-1.68 to 0) | 0.15 (0 to 0.88) |
| Change from Baseline to Week 16 | 0 (-1.81 to 0) | 0.04 (0 to 0.48) |
Median Change in Total Acne Lesions
| Total Acne Lesion Counts | Duac | Ziana |
|---|---|---|
| Change from Baseline to Week 2 | -14 (-22 to -4) | -13 (-23 to 2) |
| Change from Baseline to Week 4 | -22 (-30 to -16) | -14 (-24 to -2) |
| Change from Baseline to Week 8 | -27 (-38 to -9) | -19 (-36 to -5) |
| Change from Baseline to Week 12 | -26.5 (-36 to -15) | -23.5 (-34 to -11) |
| Change from Baseline to Week 16 | -33 (-35 to -22) | -30 (-41.5 to -17) |
Median Change in Inflammatory Acne Lesion Counts
| Lesion Counts | Duac | Ziana |
|---|---|---|
| Change from Baseline to Week 2 | -7 (-13 to -1) | -7 (-15 to -4) |
| Change from Baseline to Week 4 | -12 (-18 to -3) | -7 (-15 to -1) |
| Change from Baseline to Week 8 | -11 (-22 to -6) | -7 (-16 to -2) |
| Change from Baseline to Week 12 | -12.5 (-19 to -7) | -10.5 (-17 to -5) |
| Change from Baseline to Week 16 | -14 (-20 to -6) | -14 (-19 to -8) |
Median Change in Noninflammaotry Acne Counts
| Noninflammatory lesion counts | Duac | Ziana |
|---|---|---|
| Change from Baseline to Week 2 | -6 (-10 to 1) | -6 (-9 to 2) |
| Change from Baseline to Week 4 | -10 (-23 to -3) | -8 (-18 to 1) |
| Change from Baseline to Week 8 | -13 (-17 to -5) | -12 (-22 to 2) |
| Change from Baseline to Week 12 | -9 (-25 to -4) | -13.5 (-18 to -2) |
| Change from Baseline to Week 16 | -11 (-20 to -3) | -16.5 (-23 to -7.5) |
Collected over 16 weeks. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Duac | — | 0/27 (0%) | 5/27 (18.5%) |
| Ziana | — | 0/27 (0%) | 5/27 (18.5%) |
| Event | Duac | Ziana |
|---|---|---|
| Head ColdInfections and infestations | 2/27 | 1/27 |
| Skin surgerySkin and subcutaneous tissue disorders | 0/27 | 2/27 |
| Attention Deficit DisorderNervous system disorders | 1/27 | 0/27 |
| Sinus InfectionInfections and infestations | 1/27 | 1/27 |
| GonorrheaInfections and infestations | 1/27 | 0/27 |
| Oral ThrushInfections and infestations | 1/27 | 0/27 |
| Oily skin on faceSkin and subcutaneous tissue disorders | 0/27 | 1/27 |
| Age, Continuous(years) | Duac | Ziana | Total |
|---|---|---|---|
| Mean | 17.6 ± 6.9 | 16.2 ± 4.9 | 16.9 ± 6.0 |
| Sex: Female, Male(Participants) | Duac | Ziana | Total |
|---|---|---|---|
| Female | 14 | 15 | 29 |
| Male | 13 | 12 | 25 |
| Race/Ethnicity, Customized(Participants) | Duac | Ziana | Total |
|---|---|---|---|
| Caucasian | 21 | 22 | 43 |
| Black | 4 | 4 | 8 |
| Hispanic | 0 | 1 | 1 |
| Other | 2 | 0 | 2 |
| Region of Enrollment(participants) | Duac | Ziana | Total |
|---|---|---|---|
| United States | 27 | 27 | 54 |
| Acne Lesion Counts(Acne Lesion Counts) | Duac | Ziana | Total |
|---|---|---|---|
| Inflammatory Lesion Counts | 24.74 ± 10.61 | 22.78 ± 7.07 | 23.76 ± 8.98 |
| Noninflammatory Lesion Counts | 34.30 ± 20.38 | 35.11 ± 15.40 | 34.70 ± 17.90 |
| Total Lesion Counts | 59.04 ± 23.68 | 57.89 ± 19.99 | 58.46 ± 21.72 |
| Clinidamycin-resistant propionibacterium acne (P.acne) counts(Clinidamycin-resistant p. acne counts) | Duac | Ziana | Total |
|---|---|---|---|
| Mean | 2.29 ± 1.34 | 2.02 ± 1.21 | 2.16 ± 1.27 |
| Erythromycin-resistant lesion count(Erythromycin-resistant lesion count) | Duac | Ziana | Total |
|---|---|---|---|
| Mean | 2.29 ± 1.37 | 1.92 ± 1.11 | 2.10 ± 1.25 |
| Propionibacterium acne counts(P. acne counts) | Duac | Ziana | Total |
|---|---|---|---|
| Mean | 4.63 ± 1.12 | 4.74 ± 0.58 | 4.69 ± 0.88 |
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Stiefel, a GSK Company