NCT00663286

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

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

Enrollment
1,399

participants targeted

Target at P75+ for phase_3

Geographic Reach
1 country

33 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 (33)

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913, United States

Location

The Savin Center, PC

New Haven, Connecticut, 06511, United States

Location

Webster Dermatology, PA

Hockessin, Delaware, 19707, United States

Location

Skin Care Research, Inc.

Boca Raton, Florida, 33486, United States

Location

Advanced Dermatology and Cosmetic Surgery

Clermont, Florida, 34711, United States

Location

North Florida Dermatology Associates, PA

Jacksonville, Florida, 32204, United States

Location

Advanced Dermatology and Cosmetic Surgery

Ormond Beach, Florida, 32174, United States

Location

Dermatology Research

Pinellas Park, Florida, 33781, United States

Location

Florida Dermatology Institute

West Palm Beach, Florida, 33401, United States

Location

Derm Center of Augusta

Augusta, Georgia, 30904, United States

Location

MedaPhase Inc.

Newnan, Georgia, 30263, United States

Location

Gwinnett Clinical Research Center, Inc.

Snellville, Georgia, 30078, United States

Location

DuPage Medical Group

Naperville, Illinois, 60563, United States

Location

Hudson Dermatology

Evansville, Indiana, 47714, United States

Location

South Bend Clinic

South Bend, Indiana, 46617, United States

Location

Dermatology Specialists Research

Louisville, Kentucky, 40202, United States

Location

Michigan Center for Research Corp.

Clinton Township, Michigan, 48038, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Atlantic Dermatologic Associates, LLP

Brooklyn, New York, 11234, United States

Location

Office of Fran E. Cook-Bolden, MD

New York, New York, 10021, United States

Location

Helendale Dermatology and Medical Spa

Rochester, New York, 14609, United States

Location

Dermatology Associates of Rochester

Rochester, New York, 14623, United States

Location

DermResearch Center of New York

Stony Brook, New York, 11790, United States

Location

Central Sooner Research

Norman, Oklahoma, 73069, United States

Location

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

DermResearch, Inc.

Austin, Texas, 78759, United States

Location

J & S Studies, Inc.

Bryan, Texas, 77802, United States

Location

Thomas J. Stephens & Associates

Carrollton, Texas, 75006, United States

Location

Dallas Associated Dermatologists

Dallas, Texas, 75246, United States

Location

Education & Research Foundation

Lynchburg, Virginia, 24501, United States

Location

Virginia Clinical Research, Inc

Norfolk, Virginia, 23507, United States

Location

Madison Skin & Research, Inc.

Madison, Wisconsin, 53719, United States

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