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

• ClinicalTrials.gov Identifier: NCT00041977
• Recruitment Status: Completed
• First Posted: July 23, 2002
• Last Update Posted: June 24, 2005
• Sponsor: CollaGenex Pharmaceuticals
• Information provided by: CollaGenex Pharmaceuticals

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acne Rosacea	Drug: doxycycline hyclate 20 mg twice daily	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double
• Primary Purpose: Treatment
• 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 Start Date: June 2002

Arms and Interventions

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, Florida

University of Florida

Gainesville, Florida, United States, 32610

University of Miami Medical Center

Miami, Florida, United States, 33136

Beer and Houck/Florida Dermatology Institute

West Palm Beach, Florida, United States, 33104

United States, Kentucky

University of Louisville

Louisville, Kentucky, United States, 40202

United States, Pennsylvania

Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States, 17033

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

United States, Virginia

David Pariser, MD

Norfolk, Virginia, United States, 23507

Sponsors and Collaborators

CollaGenex Pharmaceuticals

More Information

• ClinicalTrials.gov Identifier: NCT00041977
• Other Study ID Numbers: DERM-303
• First Posted: July 23, 2002
• Last Update Posted: June 24, 2005
• Last Verified: November 2003

Keywords provided by CollaGenex Pharmaceuticals:

Rosacea

Additional relevant MeSH terms:

Rosacea; Skin Diseases; Doxycycline; Anti-Bacterial Agents; Anti-Infective Agents; Antimalarials; Antiprotozoal Agents; Antiparasitic Agents