Acne Vulgaris
Conditions
Keywords
zits, pimples, blackheads
Brief summary
The objective of the study is to evaluate the safety, tolerability, and therapeutic equivalence of GDC 268 to Clindamycin Phosphate Topical Lotion, 1% and to compare the efficacy of these two products to the GDC vehicle lotion (i.e., placebo) in the treatment of acne vulgaris.
Interventions
DRUGGDC 268 Lotion
GDC 268 is a topical lotion
DRUGClindamycin Phosphate Lotion 1%
Clindamycin Phosphate Lotion is an FDA-approved drug product
DRUGGDC Vehicle Lotion
GDC Vehicle Lotion contains 0.0% of active drug and is matched to the other two active test drugs
Sponsors
Balmoral Medical company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Male or non-pregnant, non-lactating female, ≥12 and ≤40 years of age with a clinical diagnosis of acne vulgaris. * Must have ≥ 25 but ≤ 100 non-inflammatory lesions (open and closed comedones) AND ≥ 20 but ≤ 70 inflammatory lesions (papules and pustules) AND ≤ 2 nodulocystic lesions (nodules and cysts) on the face (e.g., forehead, nose, cheeks, chin, upper lip) at Baseline. * Must be willing and able to refrain from use of all other topical products in the treatment area, all acne medications other than test article, and all antibiotics (other than test article) during the 12-week treatment period. * Women must be surgically sterile, or use an effective method of birth control with a negative urine pregnancy test (UPT) at the Baseline Visit (Day 1). * In good general health and free of any other clinically significant disease state or physical condition. * Subject has provided written informed consent / assent.
Exclusion criteria
* Subject is pregnant, breastfeeding, or is planning to become pregnant or breastfeed during the study. * Subject has more than 2 facial nodular lesions; any nodules present will be documented but not included in the inflammatory lesion count for analysis. * Subject has excessive facial hair (e.g., beards, sideburns, moustaches), facial tattoos, or other facial attributes that would interfere with diagnosis or assessment of acne vulgaris in the opinion of the investigator. * Subject is planning surgery during the study. * Subject has a history of hypersensitivity or allergy to clindamycin or lincomycin and/or any of the ingredients in the test articles. Other Eligibility Criteria not listed above will be reviewed for each prospective subject by the study staff.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Change in the Number of Inflamed Lesions | 12 weeks | Percent Change from Baseline to Week 12 in inflammatory lesion counts (Papules/Pustules). |
| Mean Percent Change in the Non-inflammatory Lesion Counts | 12 weeks | Percent Change (i.e., reduction) from Baseline to Week 12 in non-inflammatory (open and closed comedones) lesion counts. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Subjects With a Clinical Response (IGA) of Success at Week 12 | 12 weeks | Investigator's Global Assessment, IGA. Overall severity of acne was assessed using a five-point scale from 0=Clear to 4=Severe. Subjects must have had an IGA score of 2 (mild), 3 (moderate), or 4 (severe) at Baseline. Success is defined as an IGA score at week 12 that is at least 2 grades less than the baseline assessment. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events | Day 1 through Day 85 | Adverse Events (AEs) will be assessed by the investigator and the incidence (severity and causality) of any local and systemic AEs will be reported by number and percentage. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Product GDC 268 Lotion applied topically as directed.
GDC 268 Lotion: GDC 268 is a topical lotion | 496 |
| Reference Product Clindamycin Phosphate Lotion, 1% applied topically as directed.
Clindamycin Phosphate Lotion 1%: Clindamycin Phosphate Lotion is an FDA-approved drug product | 491 |
| Placebo GDC Vehicle lotion applied topically as directed.
GDC Vehicle Lotion: GDC Vehicle Lotion contains 0.0% of active drug and is matched to the other two active test drugs | 249 |
| Total | 1,236 |
Baseline characteristics
| Characteristic | Total | Placebo | Reference Product | Test Product |
|---|---|---|---|---|
| Age, Customized | 19.3 years STANDARD_DEVIATION 6 | 19.0 years STANDARD_DEVIATION 5.1 | 19.3 years STANDARD_DEVIATION 6 | 19.5 years STANDARD_DEVIATION 6.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 528 Participants | 108 Participants | 204 Participants | 216 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 708 Participants | 141 Participants | 287 Participants | 280 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Inflammatory Lesions | 28.2 Lesions STANDARD_DEVIATION 9.05 | 27.7 Lesions STANDARD_DEVIATION 8.64 | 28.4 Lesions STANDARD_DEVIATION 9.55 | 28.3 Lesions STANDARD_DEVIATION 8.74 |
| Investigator's Global Assessment 2-Mild | 321 Participants | 66 Participants | 129 Participants | 126 Participants |
| Investigator's Global Assessment 3-Moderate | 823 Participants | 172 Participants | 319 Participants | 332 Participants |
| Investigator's Global Assessment 4-Severe | 92 Participants | 11 Participants | 43 Participants | 38 Participants |
| Non-Inflammatory Lesions | 45.0 Lesions STANDARD_DEVIATION 19.77 | 45.5 Lesions STANDARD_DEVIATION 19.42 | 44.9 Lesions STANDARD_DEVIATION 19.31 | 44.9 Lesions STANDARD_DEVIATION 20.41 |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 4 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Asian | 46 Participants | 9 Participants | 17 Participants | 20 Participants |
| Race/Ethnicity, Customized Race Black or African American | 287 Participants | 54 Participants | 114 Participants | 119 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Other (multiple) | 20 Participants | 4 Participants | 8 Participants | 8 Participants |
| Race/Ethnicity, Customized Race White | 877 Participants | 181 Participants | 350 Participants | 346 Participants |
| Sex: Female, Male Female | 725 Participants | 151 Participants | 287 Participants | 287 Participants |
| Sex: Female, Male Male | 511 Participants | 98 Participants | 204 Participants | 209 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 496 | 0 / 491 | 0 / 249 |
| other Total, other adverse events | 0 / 496 | 0 / 491 | 0 / 249 |
| serious Total, serious adverse events | 0 / 496 | 0 / 491 | 0 / 249 |
Outcome results
Primary
Mean Percent Change in the Non-inflammatory Lesion Counts
Percent Change (i.e., reduction) from Baseline to Week 12 in non-inflammatory (open and closed comedones) lesion counts.
Time frame: 12 weeks
Population: Data based on the per-protocol population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Product | Mean Percent Change in the Non-inflammatory Lesion Counts | -52.7 percent change | Standard Deviation 33.98 |
| Reference Product | Mean Percent Change in the Non-inflammatory Lesion Counts | -54.3 percent change | Standard Deviation 34.44 |
| Placebo | Mean Percent Change in the Non-inflammatory Lesion Counts | -43.0 percent change | Standard Deviation 39.13 |
Primary
Mean Percent Change in the Number of Inflamed Lesions
Percent Change from Baseline to Week 12 in inflammatory lesion counts (Papules/Pustules).
Time frame: 12 weeks
Population: Analysis population is the per-protocol population defined as all subjects in the modified Intent-to-treat (mITT) population who met the following criteria: 1) Met all I/E criteria; 2) No evidence of material dosing noncompliance, 3) Completed the primary endpoint evaluation at Week 12 within the designated visit window (Day 85 ± 6 days), 4) Had no protocol violations that would affect the treatment evaluation, and 5) Did not use any prohibited medications.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Product | Mean Percent Change in the Number of Inflamed Lesions | -39.4 percent change | Standard Deviation 36.1 |
| Reference Product | Mean Percent Change in the Number of Inflamed Lesions | -40.0 percent change | Standard Deviation 36.83 |
| Placebo | Mean Percent Change in the Number of Inflamed Lesions | -35.1 percent change | Standard Deviation 35.54 |
Secondary
The Percentage of Subjects With a Clinical Response (IGA) of Success at Week 12
Investigator's Global Assessment, IGA. Overall severity of acne was assessed using a five-point scale from 0=Clear to 4=Severe. Subjects must have had an IGA score of 2 (mild), 3 (moderate), or 4 (severe) at Baseline. Success is defined as an IGA score at week 12 that is at least 2 grades less than the baseline assessment.
Time frame: 12 weeks
Population: Based on the per-protocol population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test Product | The Percentage of Subjects With a Clinical Response (IGA) of Success at Week 12 | 78 Participants |
| Reference Product | The Percentage of Subjects With a Clinical Response (IGA) of Success at Week 12 | 64 Participants |
| Placebo | The Percentage of Subjects With a Clinical Response (IGA) of Success at Week 12 | 18 Participants |
Other Pre-specified
Incidence of Adverse Events
Adverse Events (AEs) will be assessed by the investigator and the incidence (severity and causality) of any local and systemic AEs will be reported by number and percentage.
Time frame: Day 1 through Day 85
Population: Based on the Safety population defined as all subjects randomized and applied at least one dose.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test Product | Incidence of Adverse Events | 53 Participants |
| Reference Product | Incidence of Adverse Events | 41 Participants |
| Placebo | Incidence of Adverse Events | 29 Participants |