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Bioequivalence Study of Clindamycin Gel 1% in Treatment of Acne Vulgaris

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Clindamycin 1% Gel
Placebo
Sponsored by
Akorn, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

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

IInclusion Criteria:

  • Male or non-pregnant, non-lactating female, ≥12 and ≤40 years of age with a clinical diagnosis of acne vulgaris.
  • 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:

  • 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 active cystic acne.
  • Subject has acne conglobata.
  • Subjects with excessive facial hair such as beards, sideburns, moustaches, etc. that would interfere with the diagnosis or assessment of acne.

Sites / Locations

  • Site 11
  • Site 10
  • Site 1
  • Site 4
  • Site 5
  • Site 2
  • Site 3
  • Site 12
  • Site 8
  • Site 9
  • Site 6
  • Site 7

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Clindamycin 1% gel (Akorn Pharmaceuticals)

Clindamycin 1% gel (Greenstone LLC)

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Percent Change in the Number of Inflamed Lesions (Papules/Pustules)- Time Frame: Baseline to 12 Weeks
Percent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Counts - Change in Baseline to 12 Week

Secondary Outcome Measures

Full Information

First Posted
April 23, 2018
Last Updated
September 11, 2020
Sponsor
Akorn, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03522441
Brief Title
Bioequivalence Study of Clindamycin Gel 1% in Treatment of Acne Vulgaris
Official Title
A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Clindamycin 1% Gel To Clindamycin 1% Gel (Greenstone LLC) and Both Active Treatments to Vehicle Control in the Treatment of Acne Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
April 27, 2018 (Actual)
Primary Completion Date
April 22, 2019 (Actual)
Study Completion Date
April 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akorn, Inc.

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
This is a randomized, double-blind, multiple-site, placebo-controlled, parallel-group study, designed to compare the efficacy and safety of generic Clindamycin 1% gel (Akorn), and the marketed product Clindamycin 1% gel (Greenstone LLC) 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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clindamycin 1% gel (Akorn Pharmaceuticals)
Arm Type
Experimental
Arm Title
Clindamycin 1% gel (Greenstone LLC)
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Clindamycin 1% Gel
Intervention Description
Topical gel
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Topical Placebo gel
Primary Outcome Measure Information:
Title
Percent Change in the Number of Inflamed Lesions (Papules/Pustules)- Time Frame: Baseline to 12 Weeks
Time Frame
Percent change from baseline to 12 weeks
Title
Percent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Counts - Change in Baseline to 12 Week
Time Frame
Percent change in baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
IInclusion Criteria: Male or non-pregnant, non-lactating female, ≥12 and ≤40 years of age with a clinical diagnosis of acne vulgaris. 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: 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 active cystic acne. Subject has acne conglobata. Subjects with excessive facial hair such as beards, sideburns, moustaches, etc. that would interfere with the diagnosis or assessment of acne.
Facility Information:
Facility Name
Site 11
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Site 10
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Site 1
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Site 4
City
Miramar
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
Site 5
City
Miramar
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
Site 2
City
Tampa
State/Province
Florida
ZIP/Postal Code
33069
Country
United States
Facility Name
Site 3
City
Tampa
State/Province
Florida
ZIP/Postal Code
33618
Country
United States
Facility Name
Site 12
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Site 8
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Site 9
City
El Paso
State/Province
Texas
ZIP/Postal Code
79925
Country
United States
Facility Name
Site 6
City
Belize City
Country
Belize
Facility Name
Site 7
City
Belize City
Country
Belize

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Bioequivalence Study of Clindamycin Gel 1% in Treatment of Acne Vulgaris

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