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

Acne Rosacea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00041977
• Other study ID #: DERM-303
• Status: Completed
• Phase: Phase 3
• First received: July 19, 2002
• Last updated: June 23, 2005
• Start date: June 2002

Study information

• Verified date: November 2003
• Source: CollaGenex Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 a-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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Rosacea
• Rosacea

Intervention

Drug:
• doxycycline hyclate 20 mg twice daily

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida
United States	Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	University of Louisville	Louisville	Kentucky
United States	University of Miami Medical Center	Miami	Florida
United States	David Pariser, MD	Norfolk	Virginia
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Beer and Houck/Florida Dermatology Institute	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
CollaGenex Pharmaceuticals

Country where clinical trial is conducted

United States,