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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
Sponsor:
Information provided by:
CollaGenex Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE July 19, 2002
First Posted Date  ICMJE July 23, 2002
Last Update Posted Date June 24, 2005
Study Start Date  ICMJE June 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Determine the Effect of Administering Periostat(R) Twice Daily on Patients With Acne Rosacea
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Acne Rosacea
Intervention  ICMJE Drug: doxycycline hyclate 20 mg twice daily
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
150
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00041977
Other Study ID Numbers  ICMJE DERM-303
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE CollaGenex Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account CollaGenex Pharmaceuticals
Verification Date November 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP