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

Sponsor
CollaGenex Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00041977
Collaborator
(none)
150
Enrollment
7
Locations
21.4
Patients Per Site

Study Details

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
  • Drug: doxycycline hyclate 20 mg twice daily
 Phase 3

Study Design

Study Type:
Interventional
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 :
Jun 1, 2002

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Florida Gainesville Florida United States 32610
    2 University of Miami Medical Center Miami Florida United States 33136
    3 Beer and Houck/Florida Dermatology Institute West Palm Beach Florida United States 33104
    4 University of Louisville Louisville Kentucky United States 40202
    5 Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033
    6 University of Pennsylvania Philadelphia Pennsylvania United States 19104
    7 David Pariser, MD Norfolk Virginia United States 23507

    Sponsors and Collaborators

    • CollaGenex Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00041977
    Other Study ID Numbers:
    • DERM-303
    First Posted:
    Jul 23, 2002
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Nov 1, 2003
    Keywords provided by , ,
    Rosacea
    Additional relevant MeSH terms:
    Rosacea
    Doxycycline

    Study Results

    No Results Posted as of Jun 24, 2005