A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne Vulgaris

NCT ID: NCT01194375

Last Updated: 2012-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the safety and efficacy of IDP-107 versus placebo in treating patients with acne vulgaris.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acne Vulgaris

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Low Strength IDP-107

Group Type EXPERIMENTAL

Low Strength IDP-107

Intervention Type DRUG

Once a day for 16 weeks

High Strength IDP-107

Group Type EXPERIMENTAL

High Strength IDP-107

Intervention Type DRUG

Once a day for 16 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Once a day for 16 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Low Strength IDP-107

Once a day for 16 weeks

Intervention Type DRUG

High Strength IDP-107

Once a day for 16 weeks

Intervention Type DRUG

Placebo

Once a day for 16 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Presence of acne vulgaris on the face and neck/trunk
* Presence of inflammatory and non-inflammatory lesions on the face

Exclusion Criteria

* Presence of any skin condition on the face that could interfere with clinical evaluations
* Use of any systemic antibiotics or corticosteroids within 4 weeks prior to the Baseline visit
* Use of any systemic retinoids, such as isotretinoin, within 3 months prior to the Baseline visit
* Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dow Pharmaceutical Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dermatology Specialists, Inc.

Oceanside, California, United States

Site Status

Horizons Clinical Research Center, LLC

Denver, Colorado, United States

Site Status

North Florida Dermatology Associates, PA

Jacksonville, Florida, United States

Site Status

FXM Research Corp.

Miami, Florida, United States

Site Status

Ameriderm Research

Ormond Beach, Florida, United States

Site Status

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

Site Status

The Indiana Clinical Trials Center, PC

Plainfield, Indiana, United States

Site Status

Pedia Research LLC

Owensboro, Kentucky, United States

Site Status

ActivMed Practices and Research, Inc.

Haverhill, Massachusetts, United States

Site Status

Hamzavi Dermatology

Fort Gratiot, Michigan, United States

Site Status

Minnesota Clinical Study Center

Fridley, Minnesota, United States

Site Status

Comprehensive Clinical Research

Berlin, New Jersey, United States

Site Status

Oregon Dermatology and Research Center

Portland, Oregon, United States

Site Status

DermResearch, Inc.

Austin, Texas, United States

Site Status

Dermatology Research Center, Inc.

Salt Lake City, Utah, United States

Site Status

South Valley Dermatology

West Jordan, Utah, United States

Site Status

Premier Clinical Research

Spokane, Washington, United States

Site Status

Ultranova Skincare

Barrie, Ontario, Canada

Site Status

The Centre for Dermatology and Cosmetic Surgery

Richmond Hill, Ontario, Canada

Site Status

K. Papp Clinical Research

Waterloo, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DPSI-IDP-107-P2-02

Identifier Type: -

Identifier Source: org_study_id