A Study of a New Drug Treatment for Acne

Completed · Phase 2

Conditions studied: Acne Vulgaris

In brief

A study to determine if three different doses of a new acne treatment are safe and better at reducing facial acne than a treatment without active ingredient.

Key facts

Study ID

NCT01326780

Run by

Bausch Health Americas, Inc.

People needed

431

Starts

2011-03-31

Expected to finish

2012-03-31

Last updated by the study team

2019-10-16

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 12 years of age or older, with moderate facial acne vulgaris as defined in the protocol
• If female of childbearing potential, must take a pregnancy test and have a negative result
• Females of childbearing potential must also agree to use an adequate method of birth control, which would include:
• systemic birth control (Subjects must have been taking the same type of birth control for at least 3 months prior to entering the study and must not change type of birth control during the study)
• Condom with spermicide
• IUD. Females who have had a hysterectomy, bilateral oophorectomy or bilateral tubal ligation are not required to use additional birth control methods

You may not qualify if…

• Known sensitivity to any of the ingredients in the study medication
• More than 3 nodulocystic acne lesions
• Use of acne treatments, therapies or medications within protocol-specified timeframes
• Presence of other skin conditions, diseases, or medical conditions that (per protocol or in the opinion of the investigator) may require concurrent therapy, interfere with the evaluation of the study medication, or compromise subject safety
• Excessive facial hair that may interfere with application of the medication and/or evaluations

Where it is running

• University of California, San Diego — San Diego, California, United States
• University Clinical Trials, Inc. — San Diego, California, United States
• Thomas J. Stephens & Associates, Inc. — Colorado Springs, Colorado, United States
• Horizons Clinical Research Ctr., LLC — Denver, Colorado, United States
• North Florida Dermatology — Jacksonville, Florida, United States
• Hilltop Research — St. Petersburg, Florida, United States
• Gwinnett Clinical Research — Snellville, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Dermatology Specialists Research, Inc — Louisville, Kentucky, United States
• Minnesota Clinical Study Center — Fridley, Minnesota, United States
• TKL Research — Rochelle Park, New Jersey, United States
• Academic Dermatology Associates — Albuquerque, New Mexico, United States
• Wake Research Associates — Raleigh, North Carolina, United States
• Hilltop Research — Miamiville, Ohio, United States
• Penn State Medical Center — Hershey, Pennsylvania, United States
• Yardley Dermatology Associates — Yardley, Pennsylvania, United States
• Research Across America — Dallas, Texas, United States
• Reliance Clinical Testing Services — Irving, Texas, United States

Full record on ClinicalTrials.gov

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