Clinical trial NCT02465632: To Study Generic Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Glenmark Generics, Ltd) in the Treatment of Acne Vulgaris.
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Glenmark Generics, Ltd) to the Marketed Product BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5% (Valeant Pharmaceuticals, US) in the Treatment of Acne Vulgaris.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Lead sponsor: Glenmark Pharmaceuticals Ltd. India
Sponsor class: INDUSTRY
First posted: 2015-06-08
Enrollment: 1100
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: This is a randomized, double-blind, multiple-site, placebo-controlled, parallel-group study, designed to compare the efficacy and safety of generic Clindamycin 1%/ Benzoyl peroxide 5% topical gel (Glenmark Generics, Ltd), and the marketed product BenzaClin® Topical Gel, Clindamycin 1%/ Benzoyl peroxide 5% (Valeant Pharmaceuticals, US) in the treatment of acne vulgaris.


Eligibility criteria: Inclusion Criteria:

1. Male or non-pregnant, non-lactating female, ≥12 and ≤40 years of age with a clinical diagnosis of acne vulgaris.
2. Have facial acne with: ≥20 facial inflammatory lesions (papules and pustules) and ≥25 non-inflammatory lesions (open and closed comedones), and ≤2 nodulocystic lesions (nodules and cysts) and have an IGA score of 2, 3 or 4.

Exclusion Criteria:

1. Subject has more than 2 facial nodular lesions; any nodules present will be documented but not included in the inflammatory lesion count for analysis.
2. Subject has active cystic acne.
3. Subject has acne conglobata.
4. Subjects with excessive facial hair such as beards, sideburns, moustaches, etc. that would interfere with the diagnosis or assessment of acne.

Primary outcomes:
measure: Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules)
timeFrame: Baseline and 10 Weeks
measure: Mean Percent Change in the Number of Non-inflamed Lesions (Open and Closed Comedones)
timeFrame: Baseline and 10 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Glenmark Investigational Site 13
state: California
city: Long Beach
country: United States
facility: Glenmark Investigational Site 6
state: California
city: Los Angeles
country: United States
facility: Glenmark Investigational Site 15
state: California
city: West Covina
country: United States
facility: Glenmark Investigational Site12
state: California
city: Brandon
country: United States
facility: Glenmark Investigational Site 4
state: Florida
city: Miami
country: United States
facility: Glenmark Investigational Site 1
state: Florida
city: Miami
country: United States
facility: Glenmark Investigational Site 8
state: Florida
city: Miramar
country: United States
facility: Glenmark Investigational Site 9
state: Florida
city: Saint Petersburg
country: United States
facility: Glenmark Investigational Site 2
state: Florida
city: Louisville
country: United States
facility: Glenmark Investigational Site 5
state: Kentucky
city: Upper Saint Clair
country: United States
facility: Glenmark Investigational Site7
state: Pennsylvania
city: Greenville
country: United States
facility: Glenmark Investigational Site 14
state: South Carolina
city: Nashville
country: United States
facility: Glenmark Investigational Site 3
state: Tennessee
city: Belize City
country: Belize
facility: Glenmark Investigational Site 10
city: Belize City
country: Belize
facility: Glenmark Investigational Site 11
Study officials:
affiliation: Glenmark Pharmaceuticals Ltd
name: Mahesh V Deshpande
role: STUDY_DIRECTOR
References: