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

Primary Purpose

Acne Rosacea

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
doxycycline hyclate 20 mg twice daily
Sponsored by
CollaGenex Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Rosacea focused on measuring Rosacea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Florida
  • University of Miami Medical Center
  • Beer and Houck/Florida Dermatology Institute
  • University of Louisville
  • Milton S. Hershey Medical Center
  • University of Pennsylvania
  • David Pariser, MD

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 19, 2002
Last Updated
June 23, 2005
Sponsor
CollaGenex Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00041977
Brief Title
Determine the Effect of Administering Periostat(R) Twice Daily on Patients With Acne Rosacea
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 Type
Interventional

2. Study Status

Record Verification Date
November 2003
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
CollaGenex Pharmaceuticals

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Rosacea
Keywords
Rosacea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
150 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
doxycycline hyclate 20 mg twice daily

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
University of Miami Medical Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Beer and Houck/Florida Dermatology Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33104
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
David Pariser, MD
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

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

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