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	Treatment or Intervention	Phase
Acne Rosacea	Drug: doxycycline hyclate 20 mg twice daily	Phase III

Further Study Details: 

Expected Total Enrollment:  150

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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.

Florida
      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
Kentucky
      University of Louisville, Louisville,  Kentucky,  40202,  United States
Pennsylvania
      University of Pennsylvania, Philadelphia,  Pennsylvania,  19104,  United States
      Milton S. Hershey Medical Center, Hershey,  Pennsylvania,  17033,  United States
Virginia
      David Pariser, MD, Norfolk,  Virginia,  23507,  United States

Study ID Numbers:  DERM-303
Record last reviewed:  November 2003
Last Updated:  October 13, 2004
Record first received:  July 19, 2002
ClinicalTrials.gov Identifier:  NCT00041977
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08