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

This study has been completed.
Sponsor:
Information provided by:
CollaGenex Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00041977
First received: July 19, 2002
Last updated: June 23, 2005
Last verified: November 2003
  Purpose

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 Intervention Phase
Acne Rosacea
Drug: doxycycline hyclate 20 mg twice daily
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by CollaGenex Pharmaceuticals:

Estimated Enrollment: 150
Study Start Date: June 2002
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00041977

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

No publications provided

ClinicalTrials.gov Identifier: NCT00041977     History of Changes
Other Study ID Numbers: DERM-303
Study First Received: July 19, 2002
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by CollaGenex Pharmaceuticals:
Rosacea

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on October 19, 2014