Determine the Effect of Administering Periostat(R) Twice Daily on Patients With Acne Rosacea

NCT ID: NCT00041977

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-06-30

Brief 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.

Conditions

Acne Rosacea

Keywords

Rosacea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

doxycycline hyclate 20 mg twice daily

Intervention Type: DRUG

Eligibility 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.

• 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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CollaGenex Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Locations

University of Florida

Gainesville, Florida, United States

University of Miami Medical Center

Miami, Florida, United States

Beer and Houck/Florida Dermatology Institute

West Palm Beach, Florida, United States

University of Louisville

Louisville, Kentucky, United States

Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

David Pariser, MD

Norfolk, Virginia, United States

Countries

United States

Other Identifiers

DERM-303

Identifier Type: -

Identifier Source: org_study_id