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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00041977
Recruitment Status : Completed
First Posted : July 23, 2002
Last Update Posted : June 24, 2005
Information provided by:
CollaGenex Pharmaceuticals

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Rosacea
MedlinePlus related topics: Acne Rosacea

Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00041977

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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
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ClinicalTrials.gov Identifier: NCT00041977    
Other Study ID Numbers: DERM-303
First Posted: July 23, 2002    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: November 2003
Keywords provided by CollaGenex Pharmaceuticals:
Additional relevant MeSH terms:
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Skin Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents