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

NCT00041977 | Completed Phase 3

• 1 other identifier: DERM-303
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 7

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.

Conditions

Acne Rosacea

Keywords

Rosacea

Interventions

doxycycline hyclate 20 mg twice daily DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• CollaGenex Pharmaceuticals: lead

Study Sites (7)

University of Florida

Gainesville, Florida, 32610, United States

Location

University of Miami Medical Center

Miami, Florida, 33136, United States

Location

Beer and Houck/Florida Dermatology Institute

West Palm Beach, Florida, 33104, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

David Pariser, MD

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Rosacea

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 19, 2002
• First Posted: July 23, 2002
• Study Start: June 1, 2002
• Last Updated: June 24, 2005

Record last verified: 2003-11

Locations

US (7)