Acne Vulgaris
Conditions
Brief summary
This study is to determine the efficacy and safety of 12 week treatment with Differin® Gel 0.3% applied in the evening, in combination with Duac® (Clindamycin/Benzoyl Peroxide Gel) applied in the morning, in Subjects with Acne vulgaris.
Detailed description
Same as above.
Interventions
Applied once daily at bedtime
Applied once daily in the morning
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects with a minimum of 20 inflammatory lesions on the face; 2. Subjects with a minimum of 15 and a maximum of 100 non-inflammatory lesions (open and closed comedones) on the face, excluding the nose; 3. Subject has a Global Severity Assessment
Exclusion criteria
1\. Subjects with more than three nodulo-cystic lesions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change From Baseline in Total Lesion Counts | 6 and 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global Assessment of Improvement From Baseline | 12 weeks | — |
| Worst Post Baseline Tolerability Assessment - Erythema | 12 weeks | Please Note: Tolerability Assessments were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF. |
| Global Severity Assessment Success | 6 and 12 weeks | Global Severity was assessed on a 6 point scale (Clear, Almost Clear, Mild, Moderate, Severe). The scale was dichotomized to success or failure where success = Clear or Almost Clear |
| Worst Post Baseline Tolerability Assessment - Dryness | 12 weeks | Please Note: Tolerability Assessments were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF. |
| Worst Post Baseline Tolerability Assessment - Burning/Stinging | 12 weeks | Please Note: Tolerability Assessments were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF. |
| Worst Post Baseline Tolerability Assessment - Scaling | 12 weeks | Please Note: Tolerability Assessments were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Combination Therapy Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening. | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Combination Therapy |
|---|---|
| Age, Continuous | 18.2 years STANDARD_DEVIATION 5.4 |
| Duration of Acne | 4.0 years STANDARD_DEVIATION 3.91 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 93 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Fitzpatrick Skin Type I | 1 participants |
| Fitzpatrick Skin Type II | 27 participants |
| Fitzpatrick Skin Type III | 38 participants |
| Fitzpatrick Skin Type IV | 22 participants |
| Fitzpatrick Skin Type V | 4 participants |
| Fitzpatrick Skin Type VI | 8 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 77 Participants |
| Sex: Female, Male Female | 56 Participants |
| Sex: Female, Male Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 32 / 99 |
| serious Total, serious adverse events | 0 / 99 |
Outcome results
Primary
Percent Change From Baseline in Total Lesion Counts
Time frame: 6 and 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Combination Therapy | Percent Change From Baseline in Total Lesion Counts | Week 6 | -47 Percent Change | Standard Deviation 24.43 |
| Combination Therapy | Percent Change From Baseline in Total Lesion Counts | Week 12 | -64 Percent Change | Standard Deviation 24.07 |
Secondary
Global Assessment of Improvement From Baseline
Time frame: 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Combination Therapy | Global Assessment of Improvement From Baseline | Almost Clear | 40 participants |
| Combination Therapy | Global Assessment of Improvement From Baseline | Clear | 3 participants |
| Combination Therapy | Global Assessment of Improvement From Baseline | Marked Improvement | 27 participants |
| Combination Therapy | Global Assessment of Improvement From Baseline | Moderate Improvement | 16 participants |
| Combination Therapy | Global Assessment of Improvement From Baseline | Minimal Improvement | 5 participants |
| Combination Therapy | Global Assessment of Improvement From Baseline | No Change | 8 participants |
| Combination Therapy | Global Assessment of Improvement From Baseline | Worse | 1 participants |
Secondary
Global Severity Assessment Success
Global Severity was assessed on a 6 point scale (Clear, Almost Clear, Mild, Moderate, Severe). The scale was dichotomized to success or failure where success = Clear or Almost Clear
Time frame: 6 and 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Combination Therapy | Global Severity Assessment Success | Week 6 | 8 participants |
| Combination Therapy | Global Severity Assessment Success | Week 12 | 42 participants |
Secondary
Worst Post Baseline Tolerability Assessment - Burning/Stinging
Please Note: Tolerability Assessments were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
Time frame: 12 weeks
Population: Safety Population (n=99)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Combination Therapy | Worst Post Baseline Tolerability Assessment - Burning/Stinging | None | 67 participants |
| Combination Therapy | Worst Post Baseline Tolerability Assessment - Burning/Stinging | Mild | 18 participants |
| Combination Therapy | Worst Post Baseline Tolerability Assessment - Burning/Stinging | Moderate | 9 participants |
| Combination Therapy | Worst Post Baseline Tolerability Assessment - Burning/Stinging | Severe | 5 participants |
Secondary
Worst Post Baseline Tolerability Assessment - Dryness
Please Note: Tolerability Assessments were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
Time frame: 12 weeks
Population: Safety Population (n=99)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Combination Therapy | Worst Post Baseline Tolerability Assessment - Dryness | None | 49 participants |
| Combination Therapy | Worst Post Baseline Tolerability Assessment - Dryness | Mild | 27 participants |
| Combination Therapy | Worst Post Baseline Tolerability Assessment - Dryness | Moderate | 20 participants |
| Combination Therapy | Worst Post Baseline Tolerability Assessment - Dryness | Severe | 3 participants |
Secondary
Worst Post Baseline Tolerability Assessment - Erythema
Please Note: Tolerability Assessments were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
Time frame: 12 weeks
Population: Safety Population (n=99)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Combination Therapy | Worst Post Baseline Tolerability Assessment - Erythema | None | 29 participants |
| Combination Therapy | Worst Post Baseline Tolerability Assessment - Erythema | Mild | 37 participants |
| Combination Therapy | Worst Post Baseline Tolerability Assessment - Erythema | Moderate | 33 participants |
| Combination Therapy | Worst Post Baseline Tolerability Assessment - Erythema | Severe | 0 participants |
Secondary
Worst Post Baseline Tolerability Assessment - Scaling
Please Note: Tolerability Assessments were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
Time frame: 12 weeks
Population: Safety Population (n=99)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Combination Therapy | Worst Post Baseline Tolerability Assessment - Scaling | None | 53 participants |
| Combination Therapy | Worst Post Baseline Tolerability Assessment - Scaling | Mild | 27 participants |
| Combination Therapy | Worst Post Baseline Tolerability Assessment - Scaling | Moderate | 16 participants |
| Combination Therapy | Worst Post Baseline Tolerability Assessment - Scaling | Severe | 3 participants |