Acne Vulgaris
Conditions
Brief summary
Safety and efficacy study in patients with acne vulgaris
Detailed description
randomized, double-blind, placebo controlled, parallel-group, multiple-center study to evaluate the efficacy and safety of ADPS in the treatment of acne vulgaris.
Interventions
DRUGADPS topical product
topical product
DRUGPlacebo Control
topical product
Sponsors
Sun Pharmaceutical Industries, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
9 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy male or non pregnant female aged ≥ 9 years with a clinical diagnosis of acne vulgaris
Exclusion criteria
* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline to Week 12 in the Inflammatory (Papules and Pustules) Lesion Counts on the Face | Baseline to week 12 (study day 84) | — |
| Percent Change From Baseline to Week 12 in the Non-inflammatory (Open and Closed Comedones) Lesion Counts on the Face | Baseline to week 12 (study day 84) | — |
| The Percentage of Subjects With a Clinical Response (IGA) of Success at Week 12 on the Face. | Baseline to Week 12 (study day 84) | Success was defined as an IGA score that was at least two grades less than the baseline assessment. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ADPS Topical Product A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks
ADPS topical product: topical product | 147 |
| Placebo Control A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks
Placebo Control: topical product | 147 |
| Total | 294 |
Baseline characteristics
| Characteristic | ADPS Topical Product | Placebo Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 57 Participants | 58 Participants | 115 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 89 Participants | 83 Participants | 172 Participants |
| Age, Continuous | 22.1 years STANDARD_DEVIATION 8.29 | 22.4 years STANDARD_DEVIATION 8.7 | 22.2 years STANDARD_DEVIATION 8.48 |
| Body Mass Index (BMI) | 25.210 kg/m^2 STANDARD_DEVIATION 6.6911 | 26.157 kg/m^2 STANDARD_DEVIATION 6.8472 | 25.676 kg/m^2 STANDARD_DEVIATION 6.773 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 75 Participants | 69 Participants | 144 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 71 Participants | 72 Participants | 143 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 40 Participants | 41 Participants | 81 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 5 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 101 Participants | 93 Participants | 194 Participants |
| Region of Enrollment United States | 147 participants | 147 participants | 294 participants |
| Sex: Female, Male Female | 83 Participants | 98 Participants | 181 Participants |
| Sex: Female, Male Male | 63 Participants | 43 Participants | 106 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 146 | 0 / 141 |
| other Total, other adverse events | 2 / 146 | 3 / 141 |
| serious Total, serious adverse events | 0 / 146 | 1 / 141 |
Outcome results
Primary
Percent Change From Baseline to Week 12 in the Inflammatory (Papules and Pustules) Lesion Counts on the Face
Time frame: Baseline to week 12 (study day 84)
Population: The analysis population for efficacy excluded some subjects in baseline/randomized population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| ADPS Topical Product | Percent Change From Baseline to Week 12 in the Inflammatory (Papules and Pustules) Lesion Counts on the Face | -60.84 percentage change in lesion counts |
| Placebo Control | Percent Change From Baseline to Week 12 in the Inflammatory (Papules and Pustules) Lesion Counts on the Face | -62.17 percentage change in lesion counts |
p-value: 0.5947ANOVA
Primary
Percent Change From Baseline to Week 12 in the Non-inflammatory (Open and Closed Comedones) Lesion Counts on the Face
Time frame: Baseline to week 12 (study day 84)
Population: The analysis population for efficacy excluded some subjects in baseline/randomized population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| ADPS Topical Product | Percent Change From Baseline to Week 12 in the Non-inflammatory (Open and Closed Comedones) Lesion Counts on the Face | -49.91 percentage change in lesion counts |
| Placebo Control | Percent Change From Baseline to Week 12 in the Non-inflammatory (Open and Closed Comedones) Lesion Counts on the Face | -52.67 percentage change in lesion counts |
p-value: 0.2912ANOVA
Primary
The Percentage of Subjects With a Clinical Response (IGA) of Success at Week 12 on the Face.
Success was defined as an IGA score that was at least two grades less than the baseline assessment.
Time frame: Baseline to Week 12 (study day 84)
Population: The analysis population for efficacy excluded some subjects in baseline/randomized population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ADPS Topical Product | The Percentage of Subjects With a Clinical Response (IGA) of Success at Week 12 on the Face. | 13.0 Percentage of subjects |
| Placebo Control | The Percentage of Subjects With a Clinical Response (IGA) of Success at Week 12 on the Face. | 10.6 Percentage of subjects |
p-value: 0.692Cochran-Mantel-Haenszel