Determine the Effect of Administering Periostat(R) Twice Daily on Patients With Acne Rosacea
Information source: CollaGenex Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acne Rosacea
Intervention: doxycycline hyclate 20 mg twice daily (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: CollaGenex Pharmaceuticals
Summary
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.
Clinical Details
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Determine the Effects of Doxycycline Hyclate 20 Mg Tablets [Periostat(R)] Administered Twice Daily for the Treatment of Acne Rosacea
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
University of Florida, Gainesville, Florida 32610, United States
University of Miami Medical Center, Miami, Florida 33136, United States
Beer and Houck/Florida Dermatology Institute, West Palm Beach, Florida 33104, United States
University of Louisville, Louisville, Kentucky 40202, United States
University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States
Milton S. Hershey Medical Center, Hershey, Pennsylvania 17033, United States
David Pariser, MD, Norfolk, Virginia 23507, United States
Additional Information
Starting date: June 2002
Last updated: June 23, 2005
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