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

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
GDC 268 Lotion
Clindamycin Phosphate Lotion 1%
GDC Vehicle Lotion
Sponsored by
Gage Development Company, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring zits, pimples, blackheads

Eligibility Criteria

12 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Site 07
  • Site 22
  • Site 25
  • Site 33
  • Site 30
  • Site 44
  • Site 36
  • Site 45
  • Site 41
  • Site 35
  • Site 38
  • Site 37
  • Site 26
  • Site 42
  • Site 01
  • Site 10
  • Site 09
  • Site 05
  • Site 02
  • Site 27
  • Site 28
  • Site 24
  • Site 49
  • Site 06
  • Site 32
  • Site 19
  • Site 17
  • Site 34
  • Site 20
  • Site 08
  • Site 29
  • Site 03
  • Site 04
  • Site 43

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Test product

Reference Product

Placebo

Arm Description

GDC 268 Lotion applied topically as directed.

Clindamycin Phosphate Lotion, 1% applied topically as directed.

GDC Vehicle lotion applied topically as directed.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
October 22, 2018
Last Updated
April 9, 2021
Sponsor
Gage Development Company, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03717506
Brief Title
Bioequivalence Study of Clindamycin Phosphate Topical Lotion, 1% in Subjects With Acne Vulgaris
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
February 17, 2020 (Actual)
Study Completion Date
April 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gage Development Company, LLC

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
zits, pimples, blackheads

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1236 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test product
Arm Type
Experimental
Arm Description
GDC 268 Lotion applied topically as directed.
Arm Title
Reference Product
Arm Type
Active Comparator
Arm Description
Clindamycin Phosphate Lotion, 1% applied topically as directed.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
GDC Vehicle lotion applied topically as directed.
Intervention Type
Drug
Intervention Name(s)
GDC 268 Lotion
Intervention Description
GDC 268 is a topical lotion
Intervention Type
Drug
Intervention Name(s)
Clindamycin Phosphate Lotion 1%
Intervention Description
Clindamycin Phosphate Lotion is an FDA-approved drug product
Intervention Type
Drug
Intervention Name(s)
GDC Vehicle Lotion
Intervention Description
GDC Vehicle Lotion contains 0.0% of active drug and is matched to the other two active test drugs
Primary Outcome Measure Information:
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
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
Secondary Outcome Measure Information:
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
Other Pre-specified Outcome Measures:
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Site 07
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72916
Country
United States
Facility Name
Site 22
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Site 25
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Site 33
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Site 30
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Site 44
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Site 36
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Site 45
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Site 41
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
Site 35
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Site 38
City
Miami
State/Province
Florida
ZIP/Postal Code
33145
Country
United States
Facility Name
Site 37
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Site 26
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Site 42
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Site 01
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33406
Country
United States
Facility Name
Site 10
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
Site 09
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Site 05
City
Rolling Meadows
State/Province
Illinois
ZIP/Postal Code
60008
Country
United States
Facility Name
Site 02
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Site 27
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
Site 28
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Facility Name
Site 24
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Site 49
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Site 06
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Site 32
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Site 19
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43016
Country
United States
Facility Name
Site 17
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
Site 34
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Site 20
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Site 08
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Site 29
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Site 03
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130
Country
United States
Facility Name
Site 04
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Site 43
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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