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Determine the Effect of Administering Periostat(R) Twice Daily on Patients with Acne Rosacea Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Determine the Effect of Administering Periostat(R) Twice Daily on Patients with Acne Rosacea conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Determine the Effect of Administering Periostat(R) Twice Daily on Patients with Acne Rosacea Clinical research trials and Determine the Effect of Administering Periostat(R) Twice Daily on Patients with Acne Rosacea healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Determine the Effect of Administering Periostat(R) Twice Daily on Patients with Acne Rosacea. Determine the Effect of Administering Periostat(R) Twice Daily on Patients with Acne Rosacea Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Determine the Effect of Administering Periostat(R) Twice Daily on Patients with Acne Rosacea clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Determine the Effect of Administering Periostat(R) Twice Daily on Patients with Acne Rosacea condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Determine the Effect of Administering Periostat(R) Twice Daily on Patients with Acne Rosacea  Determine the Effect of Administering Periostat(R) Twice Daily on Patients with Acne Rosacea
Determine the Effect of Administering Periostat(R) Twice Daily on Patients with Acne Rosacea
For Condition: Acne Rosacea
Status: Completed
Sponsor(s): CollaGenex Pharmaceuticals ,
Synopsis: The purpose of this study is to determine whether Periostat(R), Doxycycline Hyclate 20 mg Tablets, taken twice daily is effective in reducing the red and white heads and overall redness associated with rosacea.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Healthy, post-pubescent male and females > age 18, with rosacea, 10 to 30, [papules and pustules] and < 2 nodules. - Presence of moderate to severe erythema. - Presence of telangiectasia. - Female patients must utilize one of the following methods of birth control throughout the study: IUD, diaphragm, a condom plus the use of a spermicidal gel or foam, oral contraceptives (provided patient has been utilizing this method for at least 4 months prior to baseline and has not changed the brand within this period). Patients may also participate if they are surgically sterilized, in a monogamous relationship with a sterile partner, or sign an agreement that they will abstain from sexual intercourse during the course of a study. - Patients must sign an informed consent form. - Negative pregnancy test and non-lactating. Exclusion Criteria - The initiation of a hormonal method of contraception within 4 months of baseline; or discontinuation during the course of study; or change in the actual product within 4 months of baseline or during the study. - The use of topical acne treatments within 2 weeks of baseline. - The use of systemic antibiotics within 4 weeks of baseline. - The use of an investigational drug with 90 days of baseline. - Pregnant women or women of child-bearing potential who are not using an adequate form of birth control as described in Item 4 of the Inclusion Criteria. - Nursing women. - Patients with a known hypersensitivity to tetracyclines. - Patients on clinically significant, concomitant drug therapy (See section below). - The use of any acne treatment during the course of the study. - The use of topical steroids 6 weeks prior to baseline and during the study. - The use of systemic corticosteroids 6 weeks prior to baseline and during the study. - The use of vasodilators 6 weeks prior to baseline or during the study. - The use of α-adrenergic receptor-blocking agents 6 weeks prior to baseline and during the study. Prohibited Medications: - Chronic use (> 14 days) of sulfa drugs, erythromycin, cephalosporins, and quinolones. - The use of tetracycline antibiotics is prohibited. - Use of any acne treatment during the course of the study, including spironolactone. - Chronic use (> 14 days) of NSAIDs. Chronic use of aspirin at sub-analgesic doses (< 325 mg q.d.) may be used by those patient requiring platelet aggregation inhibitor. - Penicillin antibiotics should NOT be used during the course of this trial since the bacteriostatic action of doxycycline may interfere with the bactericidal action of penicillins. - Antacids and vitamins containing aluminum, calcium, or magnesium may impair drug absorption and should be taken at least 1.5 hours before or 3.0 hours after taking study medication.
Total Enrollment: 150
Location and Contact Information:
University of Miami Medical Center
Miami, Florida, 33136
United States
University of Louisville
Louisville, Kentucky, 40202
United States
David Pariser, MD
Norfolk, Virginia, 23507
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
United States
University of Florida
Gainesville, Florida, 32610
United States
Beer and Houck/Florida Dermatology Institute
West Palm Beach, Florida, 33104
United States
Additional Information:
Study ID Numbers: DERM-303;
Study Start Date: June 2002
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00041977
Other Acne Rosacea Studies:
1. Determine the Effect of Administering Periostat(R) Twice Daily on Patients with Acne Rosacea
Related Studies:
Other Acne Rosacea Clinical Trials
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Determine the Effect of Administering Periostat(R) Twice Daily on Patients with Acne Rosacea
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