Trial Outcomes & Findings for Bioequivalence Study of Clindamycin Phosphate Topical Lotion, 1% in Subjects With Acne Vulgaris (NCT NCT03717506)
NCT ID: NCT03717506
Last Updated: 2021-05-04
Results Overview
Percent Change from Baseline to Week 12 in inflammatory lesion counts (Papules/Pustules).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1236 participants
Primary outcome timeframe
12 weeks
Results posted on
2021-05-04
Participant Flow
Participant milestones
| Measure |
Test Product
GDC 268 Lotion applied topically as directed.
GDC 268 Lotion: GDC 268 is a topical lotion
|
Reference Product
Clindamycin Phosphate Lotion, 1% applied topically as directed.
Clindamycin Phosphate Lotion 1%: Clindamycin Phosphate Lotion is an FDA-approved drug product
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
496
|
491
|
249
|
|
Overall Study
COMPLETED
|
447
|
441
|
222
|
|
Overall Study
NOT COMPLETED
|
49
|
50
|
27
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bioequivalence Study of Clindamycin Phosphate Topical Lotion, 1% in Subjects With Acne Vulgaris
Baseline characteristics by cohort
| Measure |
Test Product
n=496 Participants
GDC 268 Lotion applied topically as directed.
GDC 268 Lotion: GDC 268 is a topical lotion
|
Reference Product
n=491 Participants
Clindamycin Phosphate Lotion, 1% applied topically as directed.
Clindamycin Phosphate Lotion 1%: Clindamycin Phosphate Lotion is an FDA-approved drug product
|
Placebo
n=249 Participants
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
|
Total
n=1236 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
|
19.5 years
STANDARD_DEVIATION 6.4 • n=99 Participants
|
19.3 years
STANDARD_DEVIATION 6.0 • n=107 Participants
|
19.0 years
STANDARD_DEVIATION 5.1 • n=206 Participants
|
19.3 years
STANDARD_DEVIATION 6.0 • n=7 Participants
|
|
Sex: Female, Male
Female
|
287 Participants
n=99 Participants
|
287 Participants
n=107 Participants
|
151 Participants
n=206 Participants
|
725 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
209 Participants
n=99 Participants
|
204 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
511 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
216 Participants
n=99 Participants
|
204 Participants
n=107 Participants
|
108 Participants
n=206 Participants
|
528 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
280 Participants
n=99 Participants
|
287 Participants
n=107 Participants
|
141 Participants
n=206 Participants
|
708 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
20 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
46 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
119 Participants
n=99 Participants
|
114 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
287 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
346 Participants
n=99 Participants
|
350 Participants
n=107 Participants
|
181 Participants
n=206 Participants
|
877 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race · Other (multiple)
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
|
Investigator's Global Assessment
2-Mild
|
126 Participants
n=99 Participants
|
129 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
321 Participants
n=7 Participants
|
|
Investigator's Global Assessment
3-Moderate
|
332 Participants
n=99 Participants
|
319 Participants
n=107 Participants
|
172 Participants
n=206 Participants
|
823 Participants
n=7 Participants
|
|
Investigator's Global Assessment
4-Severe
|
38 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
92 Participants
n=7 Participants
|
|
Non-Inflammatory Lesions
|
44.9 Lesions
STANDARD_DEVIATION 20.41 • n=99 Participants
|
44.9 Lesions
STANDARD_DEVIATION 19.31 • n=107 Participants
|
45.5 Lesions
STANDARD_DEVIATION 19.42 • n=206 Participants
|
45.0 Lesions
STANDARD_DEVIATION 19.77 • n=7 Participants
|
|
Inflammatory Lesions
|
28.3 Lesions
STANDARD_DEVIATION 8.74 • n=99 Participants
|
28.4 Lesions
STANDARD_DEVIATION 9.55 • n=107 Participants
|
27.7 Lesions
STANDARD_DEVIATION 8.64 • n=206 Participants
|
28.2 Lesions
STANDARD_DEVIATION 9.05 • n=7 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: 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.
Percent Change from Baseline to Week 12 in inflammatory lesion counts (Papules/Pustules).
Outcome measures
| Measure |
Test Product
n=382 Participants
GDC 268 Lotion applied topically as directed.
GDC 268 Lotion: GDC 268 is a topical lotion
|
Reference Product
n=389 Participants
Clindamycin Phosphate Lotion, 1% applied topically as directed.
Clindamycin Phosphate Lotion 1%: Clindamycin Phosphate Lotion is an FDA-approved drug product
|
Placebo
n=193 Participants
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
|
|---|---|---|---|
|
Mean Percent Change in the Number of Inflamed Lesions
|
-39.4 percent change
Standard Deviation 36.10
|
-40.0 percent change
Standard Deviation 36.83
|
-35.1 percent change
Standard Deviation 35.54
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Data based on the per-protocol population.
Percent Change (i.e., reduction) from Baseline to Week 12 in non-inflammatory (open and closed comedones) lesion counts.
Outcome measures
| Measure |
Test Product
n=382 Participants
GDC 268 Lotion applied topically as directed.
GDC 268 Lotion: GDC 268 is a topical lotion
|
Reference Product
n=389 Participants
Clindamycin Phosphate Lotion, 1% applied topically as directed.
Clindamycin Phosphate Lotion 1%: Clindamycin Phosphate Lotion is an FDA-approved drug product
|
Placebo
n=193 Participants
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
|
|---|---|---|---|
|
Mean Percent Change in the Non-inflammatory Lesion Counts
|
-52.7 percent change
Standard Deviation 33.98
|
-54.3 percent change
Standard Deviation 34.44
|
-43.0 percent change
Standard Deviation 39.13
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Based on the per-protocol population.
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.
Outcome measures
| Measure |
Test Product
n=382 Participants
GDC 268 Lotion applied topically as directed.
GDC 268 Lotion: GDC 268 is a topical lotion
|
Reference Product
n=389 Participants
Clindamycin Phosphate Lotion, 1% applied topically as directed.
Clindamycin Phosphate Lotion 1%: Clindamycin Phosphate Lotion is an FDA-approved drug product
|
Placebo
n=193 Participants
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
|
|---|---|---|---|
|
The Percentage of Subjects With a Clinical Response (IGA) of "Success" at Week 12
|
78 Participants
|
64 Participants
|
18 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 through Day 85Population: Based on the Safety population defined as all subjects randomized and applied at least one dose.
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.
Outcome measures
| Measure |
Test Product
n=496 Participants
GDC 268 Lotion applied topically as directed.
GDC 268 Lotion: GDC 268 is a topical lotion
|
Reference Product
n=491 Participants
Clindamycin Phosphate Lotion, 1% applied topically as directed.
Clindamycin Phosphate Lotion 1%: Clindamycin Phosphate Lotion is an FDA-approved drug product
|
Placebo
n=249 Participants
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
|
|---|---|---|---|
|
Incidence of Adverse Events
|
53 Participants
|
41 Participants
|
29 Participants
|
Adverse Events
Test Product
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Reference Product
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Gage Development Clinical Trials
Gage Development Company
Phone: 1-847-999-0600
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor has first right to publish pooled study data. In the event that such manuscript has not been submitted for publication within 18 months from study completion/termination at all participating sites, the PI shall have the right to single center publications provided they submit any data for presentation, oral or written, to the Sponsor for review 60 days prior to public disclosure. The PI may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER