Acne Vulgaris
Conditions
Keywords
Mild to moderate acne vulgaris
Brief summary
The purpose of this research study is to evaluate the effectiveness of two different types of topical acne medication. This study will help to determine if one combined medication results in better acne improvement than two separate medications for acne.
Interventions
DRUGclindamycin phosphate 1.2% and tretinoin 0.025%
applied once daily for 12 weeks
Topical clindamycin applied each morning for 12 weeks
Tretinoin 0.025% cream each evening for 12 weeks
Sponsors
Medicis Pharmaceutical Corporation
Wake Forest University
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
* Males or Females 12 years of age or older with a diagnosis of mild to moderate acne vulgaris. * Subjects must sign written informed consent and agree to come for all study visits.
Exclusion criteria
* Use of experimental drugs within 1 month prior to initiation of study therapy. * Pregnant and nursing females will not be allowed in the study, and females of childbearing potential will have a pregnancy test at baseline. Females of childbearing potential must agree to use approved birth control methods for the duration of the study. * Use of systemic retinoids within 2 months of enrollment, use of any topical retinoids, systemic antibiotics, nicotinamide, systemic steroids or any other medication that may confound the results of the study within 1 month prior to start of the study * Use of any other topical medications for acne, including cosmetics containing retinol, within 2 weeks prior to study entry. * Any skin condition or disease that may require concurrent therapy or may confound the evaluation; * History of hypersensitivity to any of the formulation components; * Facial skin cancer or facial actinic keratosis; * Use of any photosensitizing agents. * Use of isotretinoin within the last 6 months. * Chemical peels, microdermabrasion or laser resurfacing within 3 months of study entry. * Crohns disease, ulcerative colitis, or have developed colitis with past antibiotic use.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measured Adherence to ZIANA Gel or Generic Topical Clindamycin 1% Gel Each Morning Plus Generic Topical Tretinoin 0.025% Cream Each Evening in Subjects With Mild to Moderate Acne | 12 weeks | Percentage of prescribed doses taken as measured by a Medication Event Monitoring System (MEMS) cap |
Secondary
| Measure | Time frame |
|---|---|
| The Change (Dynamic Assessment) From Baseline to Week 12 (or End of Treatment) in Total Acne Lesion Count | Baseline to 12 weeks |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from IRB approved advertising and the Wake Forest University Health Sciences Dermatology Clinic
Participants by arm
| Arm | Count |
|---|---|
| Ziana Gel Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks | 13 |
| Clindamycin Plus Tretinoin Applied Separately Generic clindamycin 1% gel plus tretinoin 0.025% cream | 13 |
| Total | 26 |
Baseline characteristics
| Characteristic | Clindamycin Plus Tretinoin Applied Separately | Ziana Gel | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 7 Participants | 9 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 6 Participants | 17 Participants |
| Age, Continuous | 26.2 years | 20.1 years | 23.1 years |
| Region of Enrollment United States | 13 participants | 13 participants | 26 participants |
| Sex: Female, Male Female | 6 Participants | 9 Participants | 15 Participants |
| Sex: Female, Male Male | 7 Participants | 4 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 13 | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 |
Outcome results
Primary
Measured Adherence to ZIANA Gel or Generic Topical Clindamycin 1% Gel Each Morning Plus Generic Topical Tretinoin 0.025% Cream Each Evening in Subjects With Mild to Moderate Acne
Percentage of prescribed doses taken as measured by a Medication Event Monitoring System (MEMS) cap
Time frame: 12 weeks
Population: All patients were analyzed up to end of treatment or last visit.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ziana Gel | Measured Adherence to ZIANA Gel or Generic Topical Clindamycin 1% Gel Each Morning Plus Generic Topical Tretinoin 0.025% Cream Each Evening in Subjects With Mild to Moderate Acne | 88 Percent of doses |
| Clindamycin Plus Tretinoin Applied Separately | Measured Adherence to ZIANA Gel or Generic Topical Clindamycin 1% Gel Each Morning Plus Generic Topical Tretinoin 0.025% Cream Each Evening in Subjects With Mild to Moderate Acne | 61 Percent of doses |
Secondary
The Change (Dynamic Assessment) From Baseline to Week 12 (or End of Treatment) in Total Acne Lesion Count
Time frame: Baseline to 12 weeks
Population: All patients were analyzed up to end of treatment or last visit.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ziana Gel | The Change (Dynamic Assessment) From Baseline to Week 12 (or End of Treatment) in Total Acne Lesion Count | -51 percentage of lesions |
| Clindamycin Plus Tretinoin Applied Separately | The Change (Dynamic Assessment) From Baseline to Week 12 (or End of Treatment) in Total Acne Lesion Count | -32 percentage of lesions |
p-value: 0.05Kruskal-Wallis