NCT03522441

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,125

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2018

Shorter than P25 for phase_3

Geographic Reach
2 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

April 27, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2019

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

October 5, 2020

Completed
Last Updated

October 5, 2020

Status Verified

May 1, 2018

Enrollment Period

12 months

First QC Date

April 23, 2018

Results QC Date

August 12, 2020

Last Update Submit

September 11, 2020

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

Clindamycin 1% gel (Akorn Pharmaceuticals)

EXPERIMENTAL
Drug: Clindamycin 1% Gel

Clindamycin 1% gel (Greenstone LLC)

ACTIVE COMPARATOR
Drug: Clindamycin 1% Gel

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Clindamycin 1% GelDRUG

Topical gel

Clindamycin 1% gel (Akorn Pharmaceuticals)Clindamycin 1% gel (Greenstone LLC)
PlaceboDRUG

Topical Placebo gel

Placebo

Eligibility Criteria

Age12 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Site 11

Encino, California, 91436, United States

Location

Site 10

Sherman Oaks, California, 91403, United States

Location

Site 1

Brandon, Florida, 33511, United States

Location

Site 4

Miramar, Florida, 33027, United States

Location

Site 5

Miramar, Florida, 33027, United States

Location

Site 2

Tampa, Florida, 33069, United States

Location

Site 3

Tampa, Florida, 33618, United States

Location

Site 12

High Point, North Carolina, 27262, United States

Location

Site 8

El Paso, Texas, 79902, United States

Location

Site 9

El Paso, Texas, 79925, United States

Location

Site 6

Belize City, Belize

Location

Site 7

Belize City, Belize

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

ClindamycinGels

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

LincomycinLincosamidesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsGlycosidesCarbohydratesColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Results Point of Contact

Title
Zaidoon A. Al-Zubaidy
Organization
Catawba
Zaidoon@catawbaresearch.com
1-980-242-3977

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2018

First Posted

May 11, 2018

Study Start

April 27, 2018

Primary Completion

April 22, 2019

Study Completion

April 22, 2019

Last Updated

October 5, 2020

Results First Posted

October 5, 2020

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

US(10)BE(2)