Bioequivalence Study of Clindamycin Phosphate Topical Lotion, 1% in Subjects With Acne Vulgaris

• Sponsor: Gage Development Company, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03717506
• Collaborator: (none)
• Enrollment: 1,236
• Locations: 34
• Arms: 3
• Actual Duration (Months): 18.2
• Patients Per Site: 36.4
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: GDC 268 Lotion; Drug: Clindamycin Phosphate Lotion 1%; Drug: GDC Vehicle Lotion	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 1236 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study to Determine the Therapeutic Equivalence of GDC 268 and Clindamycin Phosphate Topical Lotion, 1% in Subjects With Acne Vulgaris
• Actual Study Start Date: Oct 10, 2018
• Actual Primary Completion Date: Feb 17, 2020
• Actual Study Completion Date: Apr 16, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test product GDC 268 Lotion applied topically as directed.	Drug: GDC 268 Lotion; GDC 268 is a topical lotion
Active Comparator: Reference Product Clindamycin Phosphate Lotion, 1% applied topically as directed.	Drug: Clindamycin Phosphate Lotion 1%; Clindamycin Phosphate Lotion is an FDA-approved drug product
Placebo Comparator: Placebo GDC Vehicle lotion applied topically as directed.	Drug: GDC Vehicle Lotion; GDC Vehicle Lotion contains 0.0% of active drug and is matched to the other two active test drugs

Outcome Measures

Primary Outcome Measures

1. Mean Percent Change in the Number of Inflamed Lesions [12 weeks]

   Percent Change from Baseline to Week 12 in inflammatory lesion counts (Papules/Pustules).

2. 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 Outcome Measures

1. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site 07	Fort Smith	Arkansas	United States	72916
2	Site 22	Rogers	Arkansas	United States	72758
3	Site 25	Fountain Valley	California	United States	92708
4	Site 33	Northridge	California	United States	91324
5	Site 30	San Diego	California	United States	92103
6	Site 44	Aventura	Florida	United States	33180
7	Site 36	Brandon	Florida	United States	33511
8	Site 45	DeLand	Florida	United States	32720
9	Site 41	Largo	Florida	United States	33770
10	Site 35	Miami Lakes	Florida	United States	33014
11	Site 38	Miami	Florida	United States	33145
12	Site 37	North Miami Beach	Florida	United States	33162
13	Site 26	Saint Petersburg	Florida	United States	33709
14	Site 42	Tampa	Florida	United States	33609
15	Site 01	West Palm Beach	Florida	United States	33406
16	Site 10	Newnan	Georgia	United States	30263
17	Site 09	Boise	Idaho	United States	83704
18	Site 05	Rolling Meadows	Illinois	United States	60008
19	Site 02	Plainfield	Indiana	United States	46168
20	Site 27	Overland Park	Kansas	United States	66215
21	Site 28	Clarkston	Michigan	United States	48346
22	Site 24	Fridley	Minnesota	United States	55432
23	Site 49	Omaha	Nebraska	United States	68134
24	Site 06	High Point	North Carolina	United States	27262
25	Site 32	Raleigh	North Carolina	United States	27612
26	Site 19	Dublin	Ohio	United States	43016
27	Site 17	Gresham	Oregon	United States	97030
28	Site 34	Philadelphia	Pennsylvania	United States	19103
29	Site 20	Warwick	Rhode Island	United States	02886
30	Site 08	Anderson	South Carolina	United States	29621
31	Site 29	Chattanooga	Tennessee	United States	37421
32	Site 03	Murfreesboro	Tennessee	United States	37130
33	Site 04	Nashville	Tennessee	United States	37215
34	Site 43	Sugar Land	Texas	United States	77479

Sponsors and Collaborators

• Gage Development Company, LLC

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 6, 2019

More Information

Publications

None provided.

• Responsible Party: Gage Development Company, LLC
• ClinicalTrials.gov Identifier: NCT03717506
• Other Study ID Numbers: GDC-268-001
• First Posted: Oct 24, 2018
• Last Update Posted: May 4, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Gage Development Company, LLC: zits; pimples; blackheads
• Additional relevant MeSH terms: Acne Vulgaris; Clindamycin; Clindamycin palmitate; Clindamycin phosphate

Study Results

Participant Flow

Arm/Group Title	Test Product	Reference Product	Placebo
Arm/Group Description	GDC 268 Lotion applied topically as directed. GDC 268 Lotion: GDC 268 is a topical lotion	Clindamycin Phosphate Lotion, 1% applied topically as directed. Clindamycin Phosphate Lotion 1%: Clindamycin Phosphate Lotion is an FDA-approved drug product	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
Period Title: Overall Study
STARTED	496	491	249
COMPLETED	447	441	222
NOT COMPLETED	49	50	27

Baseline Characteristics

Arm/Group Title	Test Product	Reference Product	Placebo	Total
Arm/Group Description	GDC 268 Lotion applied topically as directed. GDC 268 Lotion: GDC 268 is a topical lotion	Clindamycin Phosphate Lotion, 1% applied topically as directed. Clindamycin Phosphate Lotion 1%: Clindamycin Phosphate Lotion is an FDA-approved drug product	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 of all reporting groups
Overall Participants	496	491	249	1236
Age, Customized (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	19.5 (6.4)	19.3 (6.0)	19.0 (5.1)	19.3 (6.0)
Sex: Female, Male (Count of Participants)
Female	287 57.9%	287 58.5%	151 60.6%	725 58.7%
Male	209 42.1%	204 41.5%	98 39.4%	511 41.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	216 43.5%	204 41.5%	108 43.4%	528 42.7%
Not Hispanic or Latino	280 56.5%	287 58.5%	141 56.6%	708 57.3%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaska Native	2 0.4%	2 0.4%	0 0%	4 0.3%
Asian	20 4%	17 3.5%	9 3.6%	46 3.7%
Black or African American	119 24%	114 23.2%	54 21.7%	287 23.2%
Native Hawaiian or Other Pacific Islander	1 0.2%	0 0%	1 0.4%	2 0.2%
White	346 69.8%	350 71.3%	181 72.7%	877 71%
Other (multiple)	8 1.6%	8 1.6%	4 1.6%	20 1.6%
Investigator's Global Assessment (Count of Participants)
2-Mild	126 25.4%	129 26.3%	66 26.5%	321 26%
3-Moderate	332 66.9%	319 65%	172 69.1%	823 66.6%
4-Severe	38 7.7%	43 8.8%	11 4.4%	92 7.4%
Non-Inflammatory Lesions (Lesions) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Lesions]	44.9 (20.41)	44.9 (19.31)	45.5 (19.42)	45.0 (19.77)
Inflammatory Lesions (Lesions) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Lesions]	28.3 (8.74)	28.4 (9.55)	27.7 (8.64)	28.2 (9.05)

Outcome Measures

1. Primary Outcome

Title	Mean Percent Change in the Number of Inflamed Lesions
Description	Percent Change from Baseline to Week 12 in inflammatory lesion counts (Papules/Pustules).
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

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/Group Title	Test Product	Reference Product	Placebo
Arm/Group Description	GDC 268 Lotion applied topically as directed. GDC 268 Lotion: GDC 268 is a topical lotion	Clindamycin Phosphate Lotion, 1% applied topically as directed. Clindamycin Phosphate Lotion 1%: Clindamycin Phosphate Lotion is an FDA-approved drug product	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
Measure Participants	382	389	193
Mean (Standard Deviation) [percent change]	-39.4 (36.10)	-40.0 (36.83)	-35.1 (35.54)

2. Primary Outcome

Title	Mean Percent Change in the Non-inflammatory Lesion Counts
Description	Percent Change (i.e., reduction) from Baseline to Week 12 in non-inflammatory (open and closed comedones) lesion counts.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Data based on the per-protocol population.

Arm/Group Title	Test Product	Reference Product	Placebo
Arm/Group Description	GDC 268 Lotion applied topically as directed. GDC 268 Lotion: GDC 268 is a topical lotion	Clindamycin Phosphate Lotion, 1% applied topically as directed. Clindamycin Phosphate Lotion 1%: Clindamycin Phosphate Lotion is an FDA-approved drug product	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
Measure Participants	382	389	193
Mean (Standard Deviation) [percent change]	-52.7 (33.98)	-54.3 (34.44)	-43.0 (39.13)

3. Secondary Outcome

Title	The Percentage of Subjects With a Clinical Response (IGA) of "Success" at Week 12
Description	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

Outcome Measure Data

Analysis Population Description

Based on the per-protocol population.

Arm/Group Title	Test Product	Reference Product	Placebo
Arm/Group Description	GDC 268 Lotion applied topically as directed. GDC 268 Lotion: GDC 268 is a topical lotion	Clindamycin Phosphate Lotion, 1% applied topically as directed. Clindamycin Phosphate Lotion 1%: Clindamycin Phosphate Lotion is an FDA-approved drug product	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
Measure Participants	382	389	193
Count of Participants [Participants]	78 15.7%	64 13%	18 7.2%

4. Other Pre-specified Outcome

Title	Incidence of Adverse Events
Description	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

Outcome Measure Data

Analysis Population Description

Based on the Safety population defined as all subjects randomized and applied at least one dose.

Arm/Group Title	Test Product	Reference Product	Placebo
Arm/Group Description	GDC 268 Lotion applied topically as directed. GDC 268 Lotion: GDC 268 is a topical lotion	Clindamycin Phosphate Lotion, 1% applied topically as directed. Clindamycin Phosphate Lotion 1%: Clindamycin Phosphate Lotion is an FDA-approved drug product	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
Measure Participants	496	491	249
Count of Participants [Participants]	53 10.7%	41 8.4%	29 11.6%

Adverse Events

Time Frame	12 Weeks
Arm/Group Title	Test Product		Reference Product		Placebo
Arm/Group Description	GDC 268 Lotion applied topically as directed. GDC 268 Lotion: GDC 268 is a topical lotion		Clindamycin Phosphate Lotion, 1% applied topically as directed. Clindamycin Phosphate Lotion 1%: Clindamycin Phosphate Lotion is an FDA-approved drug		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
All Cause Mortality
	Test Product		Reference Product		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/496 (0%)		0/491 (0%)		0/249 (0%)
Serious Adverse Events
	Test Product		Reference Product		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/496 (0%)		0/491 (0%)		0/249 (0%)
Other (Not Including Serious) Adverse Events
	Test Product		Reference Product		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/496 (0%)		0/491 (0%)		0/249 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.