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

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

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Clindamycin 1% Gel; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1125
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belize
  • Belize City, Belize
    • Site 6
  • Belize City, Belize
    • Site 7
• United States
  • California
    • Encino, California, United States, 91436
      • Site 11
    • Sherman Oaks, California, United States, 91403
      • Site 10
  • Florida
    • Brandon, Florida, United States, 33511
      • Site 1
    • Miramar, Florida, United States, 33027
      • Site 4
    • Miramar, Florida, United States, 33027
      • Site 5
    • Tampa, Florida, United States, 33069
      • Site 2
    • Tampa, Florida, United States, 33618
      • Site 3
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Site 12
  • Texas
    • El Paso, Texas, United States, 79902
      • Site 8
    • El Paso, Texas, United States, 79925
      • Site 9

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Topical Placebo gel
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Akorn, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2018
• Primary Completion (Actual): April 22, 2019
• Study Completion (Actual): April 22, 2019

Study Registration Dates

• First Submitted: April 23, 2018
• First Submitted That Met QC Criteria: May 10, 2018
• First Posted (Actual): May 11, 2018

Study Record Updates

• Last Update Posted (Actual): October 5, 2020
• Last Update Submitted That Met QC Criteria: September 11, 2020
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Clindamycin; Clindamycin palmitate; Clindamycin phosphate
• Other Study ID Numbers: CLMG 1711

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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