Clinical trial NCT03717506: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Keywords: zits
pimples
blackheads
Lead sponsor: Balmoral Medical company
Sponsor class: INDUSTRY
First posted: 2018-10-24
Enrollment: 1236
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Mean Percent Change in the Number of Inflamed Lesions
timeFrame: 12 weeks
measure: Mean Percent Change in the Non-inflammatory Lesion Counts
timeFrame: 12 weeks
Secondary outcomes:
measure: The Percentage of Subjects With a Clinical Response (IGA) of "Success" at Week 12
timeFrame: 12 weeks
Other outcomes:
measure: Incidence of Adverse Events
timeFrame: Day 1 through Day 85
Locations:
city: Fort Smith
country: United States
facility: Site 07
state: Arkansas
city: Rogers
country: United States
facility: Site 22
state: Arkansas
city: Fountain Valley
country: United States
facility: Site 25
state: California
city: Northridge
country: United States
facility: Site 33
state: California
city: San Diego
country: United States
facility: Site 30
state: California
city: Aventura
country: United States
facility: Site 44
state: Florida
city: Brandon
country: United States
facility: Site 36
state: Florida
city: DeLand
country: United States
facility: Site 45
state: Florida
city: Largo
country: United States
facility: Site 41
state: Florida
city: Miami Lakes
country: United States
facility: Site 35
state: Florida
city: Miami
country: United States
facility: Site 38
state: Florida
city: North Miami Beach
country: United States
facility: Site 37
state: Florida
city: Saint Petersburg
country: United States
facility: Site 26
state: Florida
city: Tampa
country: United States
facility: Site 42
state: Florida
city: West Palm Beach
country: United States
facility: Site 01
state: Florida
city: Newnan
country: United States
facility: Site 10
state: Georgia
city: Boise
country: United States
facility: Site 09
state: Idaho
city: Rolling Meadows
country: United States
facility: Site 05
state: Illinois
city: Plainfield
country: United States
facility: Site 02
state: Indiana
city: Overland Park
country: United States
facility: Site 27
state: Kansas
city: Clarkston
country: United States
facility: Site 28
state: Michigan
city: Fridley
country: United States
facility: Site 24
state: Minnesota
city: Omaha
country: United States
facility: Site 49
state: Nebraska
city: High Point
country: United States
facility: Site 06
state: North Carolina
city: Raleigh
country: United States
facility: Site 32
state: North Carolina
city: Dublin
country: United States
facility: Site 19
state: Ohio
city: Gresham
country: United States
facility: Site 17
state: Oregon
city: Philadelphia
country: United States
facility: Site 34
state: Pennsylvania
city: Warwick
country: United States
facility: Site 20
state: Rhode Island
city: Anderson
country: United States
facility: Site 08
state: South Carolina
city: Chattanooga
country: United States
facility: Site 29
state: Tennessee
city: Murfreesboro
country: United States
facility: Site 03
state: Tennessee
city: Nashville
country: United States
facility: Site 04
state: Tennessee
city: Sugar Land
country: United States
facility: Site 43
state: Texas
Study officials:
References: