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| Sponsor: | Galderma Laboratories, L.P. |
|---|---|
| Information provided by (Responsible Party): | Galderma Laboratories, L.P. |
| ClinicalTrials.gov Identifier: | NCT01308619 |
Purpose
The objective of this study is to determine the clinical effects of doxycycline 40 mg (30 mg immediate release and 10 mg delayed release beads) capsules (Oracea®) as compared to placebo in the skin of adults with papulopustular rosacea and to identify a correlation, if any, with rosacea-related inflammatory markers.
| Condition | Intervention | Phase |
|---|---|---|
|
Rosacea |
Drug: Doxycycline Other: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Double-blind, Placebo-controlled Evaluation of Rosacea-related Inflammatory Biochemical Markers in the Skin of Adults With Papulopustular Rosacea Treated With Daily Doxycycline 40 mg (30 mg Immediate Release / 10 mg Delayed Release Beads) Capsules |
| Estimated Enrollment: | 170 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | April 2012 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Oracea®
Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules
|
Drug: Doxycycline
doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules, oral, one capsule daily in the morning
Other Name: Oracea®
|
|
Active Comparator: placebo
placebo
|
Other: Placebo
Placebo, oral, one capsule daily in the morning
Other Name: Placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Joseph Scarborough | 845-656-5682 | jscarborough@acmeresearch.net |
| United States, Arkansas | |
| Burke Pharmaceutical Research | Recruiting |
| Hot Springs, Arkansas, United States, 71913 | |
| Contact: Tim Dugan 501-620-4449 tdugan@burkepharmaceutical.com | |
| Principal Investigator: Dowling B Stough, MD | |
| United States, California | |
| Vitiligo & Pigmentation Institute | Withdrawn |
| Los Angeles, California, United States, 90004 | |
| Therapeutics Clinical Research | Recruiting |
| San Diego, California, United States, 92123 | |
| Contact: Angie Owens 858-571-6800 aowens@therapeuticsinc.com | |
| Contact: Ligia Iova 858-571-6800 liova@therapeuticsresearch.com | |
| Principal Investigator: Eugene Huang, MD | |
| United States, Indiana | |
| Hudson Dermatology | Recruiting |
| Evansville, Indiana, United States, 47714 | |
| Contact: Kim Morrison, BA 812-477-2760 kmorrison22@att.net | |
| Principal Investigator: Charles P Hudson, MD | |
| The Indiana Clinical Trials Center | Recruiting |
| Plainfield, Indiana, United States, 46168 | |
| Contact: Kimmie Eads 317-837-6082 ictcsc1@indy.rr.com | |
| Principal Investigator: Scott T Guenthner, MD | |
| United States, Michigan | |
| Michigan Center for Research Corp | Recruiting |
| Clinton Township, Michigan, United States, 48038 | |
| Contact: Patrice Robertson 586-286-7325 probertson@skincareresearch.com | |
| Principal Investigator: Daniel Stewart, DO | |
| United States, New Mexico | |
| Academic Dermatology Associates | Withdrawn |
| Albuquerque, New Mexico, United States, 87106 | |
| United States, New York | |
| Skin Search of Rochester, Inc | Recruiting |
| Rochester, New York, United States, 14623 | |
| Contact: Jennifer Goodrich, RN 585-697-1818 jgoodrich@skinsearch.org | |
| Principal Investigator: John Tu, MD | |
| United States, Oregon | |
| Oregon Medical Research Center, PC | Recruiting |
| Portland, Oregon, United States, 97223 | |
| Contact: Jennifer Logan 503-245-1525 jlogan.omrc@comcast.net | |
| Principal Investigator: Robert Matheson, MD | |
| United States, Texas | |
| Derm Research | Recruiting |
| Austin, Texas, United States, 78759 | |
| Contact: Martha Withers 512-349-9889 mwithers@dermresearch.net | |
| Principal Investigator: Michael Jarratt, MD | |
| J & S Studies, Inc. | Recruiting |
| College Station, Texas, United States, 77845 | |
| Contact: Jeremy Scott, CCRC 979-774-5933 jscott@js-studies.com | |
| Principal Investigator: Terry Jones, MD | |
| Suzanne Bruce and Associates, PA | Recruiting |
| Houston, Texas, United States, 77056 | |
| Contact: Merdedez Freeman 713-850-0240 ext 156 mfreeman@sba-skincare.com | |
| Contact: Jasmine Leung 713-850-0240 ext 104 jleung@sba-skincare.com | |
| Principal Investigator: Suzanne Bruce, MD | |
| Study Director: | Ronald W Gottschalk, MD | Galderma Laboratories, L.P. |
More Information
| Responsible Party: | Galderma Laboratories, L.P. |
| ClinicalTrials.gov Identifier: | NCT01308619 History of Changes |
| Other Study ID Numbers: | US10150 |
| Study First Received: | March 2, 2011 |
| Last Updated: | February 6, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
Rosacea Skin Diseases Doxycycline Doxycycline hyclate Anti-Bacterial Agents Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Antimalarials Antiprotozoal Agents Antiparasitic Agents |