NCT00664248

Brief Summary

The purpose of this study is to assess the effectiveness of IDP-110 in treating patients with acne vulgaris.

Trial Health

85
On Track

Trial Health Score

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

Enrollment
1,414

participants targeted

Target at P75+ for phase_3

Geographic Reach
3 countries

35 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

Study Start

First participant enrolled

October 1, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 22, 2008

Completed
Last Updated

April 22, 2008

Status Verified

April 1, 2008

Enrollment Period

10 months

First QC Date

April 15, 2008

Last Update Submit

April 18, 2008

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in number of lesions

    12 weeks

Secondary Outcomes (1)

  • Change from baseline in global severity

    12 weeks

Study Arms (4)

1

EXPERIMENTAL
Drug: IDP-110

2

ACTIVE COMPARATOR
Drug: Clindamycin

3

ACTIVE COMPARATOR
Drug: Benzoyl peroxide

4

PLACEBO COMPARATOR
Drug: Vehicle

Interventions

Topical application for 12 weeks

1

Topical application for 12 weeks

2

Topical application for 12 weeks

3

Topical application for 12 weeks

4

Eligibility Criteria

Age12 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Presence of inflammatory and non-inflammatory lesions

You may not qualify if:

  • Dermatological conditions of the face other than acne that could interfere with clinical evaluations
  • Female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (35)

Total Skin and Beauty Dermatology Center

Birmingham, Alabama, 35205, United States

Location

University of Alabama, Birmingham

Birmingham, Alabama, 35233, United States

Location

Medical Affiliated Research Center, Inc.

Huntsville, Alabama, 35801, United States

Location

Dermatology Research of Arkansas

Little Rock, Arkansas, 72205, United States

Location

Affiliated Research Institute - Dermatology

San Diego, California, 92108, United States

Location

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

University of California, San Diego, Pediatric and Adolescent Dermatology

San Diego, California, 92123, United States

Location

Solano Clinical Research

Vallejo, California, 94589, United States

Location

Dermatology Specialists, Inc.

Vista, California, 92083, United States

Location

Clinical Research Specialists

West Santa Monica, California, 90404-2115, United States

Location

Cherry Creek Dermatology Research Inc.

Denver, Colorado, 80246, United States

Location

Longmont Medical Research Network

Longmont, Colorado, 80501, United States

Location

International Dermatology Research, Inc.

Miami, Florida, 33144, United States

Location

FXM Research

Miami, Florida, 33175, United States

Location

Office of Scott Glazer, MD

Buffalo Grove, Illinois, 60089, United States

Location

Henry Ford Medical Center

Detroit, Michigan, 48202, United States

Location

The Nevada Center for Dermatology

Reno, Nevada, 89511, United States

Location

Academic Dermatology

Albuquerque, New Mexico, 87106, United States

Location

Triangle Medical Research Associates

Cary, North Carolina, 27511, United States

Location

Unifour Medical Research Associates

Hickory, North Carolina, 28601, United States

Location

Wake Research Associates, LLC

Raleigh, North Carolina, 27612, United States

Location

New Haven Medical Research

Wilmington, North Carolina, 28401, United States

Location

Northwest Cutaneous Research Specialists

Portland, Oregon, 97210, United States

Location

Oregon Medical Center, PC

Portland, Oregon, 97223, United States

Location

Rivergate Dermatology

Goodlettsville, Tennessee, 37072, United States

Location

Dermatology Associates

Knoxville, Tennessee, 37922, United States

Location

Dermatology Research Associates

Nashville, Tennessee, 37203, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

The Center for Skin Research

Houston, Texas, 77056, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78229, United States

Location

Dermatology Resarch Center

Salt Lake City, Utah, 84124, United States

Location

Advanced Clinical Research - Jordan Valley

West Jordan, Utah, 84088, United States

Location

Advanced Healthcare

Milwaukee, Wisconsin, 53209, United States

Location

Dermatology and Skin Surgery Centre

Belize City, Belize

Location

Mediprobe Research

New London, Ontario, N5X 2P1, Canada

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

ClindamycinBenzoyl Peroxide

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

LincomycinLincosamidesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsGlycosidesCarbohydratesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Design

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

Study Record Dates

First Submitted

April 15, 2008

First Posted

April 22, 2008

Study Start

October 1, 2006

Primary Completion

August 1, 2007

Last Updated

April 22, 2008

Record last verified: 2008-04

Locations