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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03522441
Recruitment Status : Completed
First Posted : May 11, 2018
Results First Posted : October 5, 2020
Last Update Posted : October 5, 2020
Information provided by (Responsible Party):
Akorn, Inc.

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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Clindamycin 1% Gel Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : April 27, 2018
Actual Primary Completion Date : April 22, 2019
Actual Study Completion Date : April 22, 2019

Arm Intervention/treatment
Experimental: Clindamycin 1% gel (Akorn Pharmaceuticals) Drug: Clindamycin 1% Gel
Topical gel

Active Comparator: Clindamycin 1% gel (Greenstone LLC) Drug: Clindamycin 1% Gel
Topical gel

Placebo Comparator: Placebo Drug: Placebo
Topical Placebo gel

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522441

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United States, California
Site 11
Encino, California, United States, 91436
Site 10
Sherman Oaks, California, United States, 91403
United States, Florida
Site 1
Brandon, Florida, United States, 33511
Site 4
Miramar, Florida, United States, 33027
Site 5
Miramar, Florida, United States, 33027
Site 2
Tampa, Florida, United States, 33069
Site 3
Tampa, Florida, United States, 33618
United States, North Carolina
Site 12
High Point, North Carolina, United States, 27262
United States, Texas
Site 8
El Paso, Texas, United States, 79902
Site 9
El Paso, Texas, United States, 79925
Site 6
Belize City, Belize
Site 7
Belize City, Belize
Sponsors and Collaborators
Akorn, Inc.
  Study Documents (Full-Text)

Documents provided by Akorn, Inc.:
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Responsible Party: Akorn, Inc.
ClinicalTrials.gov Identifier: NCT03522441    
Other Study ID Numbers: CLMG 1711
First Posted: May 11, 2018    Key Record Dates
Results First Posted: October 5, 2020
Last Update Posted: October 5, 2020
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Clindamycin palmitate
Clindamycin phosphate
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action