Clinical trial NCT01513863: A Therapeutic Equivalence Study of Two Metronidazole 1%Topical Gel Treatments for Patients With Rosacea
Official title: A Randomized, Double-Blind, Placebo Controlled, Parallel Design, Multi-Site Clinical Study to Compare the Bioequivalence of Two Metronidazole 1% Topical Gel Formulations in Patients With Moderate to Severe Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rosacea
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2012-01-20
Enrollment: 602
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to demonstrate that metronidazole 1% topical gel is effective for the treatment of patients with moderate to severe rosacea.


Eligibility criteria: Inclusion Criteria:

1. Male or non-pregnant, non-lactating female, 18 years of age or older.
2. Signed informed consent form, which meets all criteria of current FDA regulations.
3. If female and of child bearing potential, prepare to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom, IUD, oral, transdermal, injected or implanted hormonal contraceptives).
4. Have moderate to severe facial rosacea.
5. Have a Baseline Investigator Global Evaluation Score of 3 or 4.

Exclusion Criteria:

1. Mild facial rosacea (less than 8 inflammatory lesions on the face) or very severe rosacea (more than 50 inflammatory lesions)
2. Patients with excessive facial hair (beards, sideburns, moustaches, etc.) that would interfere with the diagnosis or assessment of rosacea.
3. History of hypersensitivity or allergy to Metronidazole, or other ingredients of the formulation.
4. Use of oral retinoids (e.g. Accutane ®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed) within the 6 months prior to the baseline visit.
5. Use of the following within 1 month prior to the baseline visit:

   * Topical Retinoids to the face
   * Systemic antibiotics known to have an impact on the severity of facial Rosacea
   * Systemic Steroids
6. The use of anticoagulant therapy within 14 days prior to baseline.
7. The use of any antipruritics, including antihistamines within 24 hours of any study visits.
8. History of blood dyscrasia.
9. Ocular rosacea (e.g., conjunctivitis, blepharitis, keratitis) of sufficient severity to require topical or systemic antibiotics.
10. Any dermatological condition other than rosacea that in the Investigator's opinion may interfere with the evaluation of the Patient's rosacea (e.g., acne, psoriasis, dermatitis).
11. Females who are pregnant, lactating or likely to become pregnant during the study.
12. Significant history or current evidence of chronic infectious disease, system disorder, organ disorder or other medical condition that in the Investigator's opinion would place the study Patient at undue risk by participation.
13. Any Patient (male or female) who has started, or changed hormonal therapy within 3 months of the Baseline visit (this includes hormonal contraceptives).
14. Use of high strength (20% or above) alpha-hydroxy acid for facial peel or any type of chemical facial skin peel or other significant cosmetic procedures within 2 months of the study start.
15. Receipt of any drug as part of a research study within 30 days prior to dosing.
16. Employees of the research center or Investigator.
17. Previous participation in this study.

Primary outcomes:
measure: Clinical Success
timeFrame: Day 70
measure: Treatment Success
timeFrame: Day 70
Secondary outcomes:
measure: Change in Investigational Global Evaluation (IGE)
timeFrame: Day 70
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Investigator Site
state: Arizona
city: Long Beach
country: United States
facility: Investigator Site
state: California
city: Newport Beach
country: United States
facility: Investigator Site
state: California
city: Denver
country: United States
facility: Investigator Site
state: Colorado
city: Jacksonville
country: United States
facility: Investigator Site
state: Florida
city: Miami
country: United States
facility: Investigator Site
state: Florida
city: Miramar
country: United States
facility: Investigator Site
state: Florida
city: Arlington Heights
country: United States
facility: Investigator Site
state: Illinois
city: Plainfield
country: United States
facility: Investigator Site
state: Indiana
city: Henderson
country: United States
facility: Investigator Site
state: Nevada
city: Hickory
country: United States
facility: Investigator Site
state: North Carolina
city: High Point
country: United States
facility: Investigator Site
state: North Carolina
city: Wilmington
country: United States
facility: Investigator Site
state: North Carolina
city: South Euclid
country: United States
facility: Investigator Site
state: Ohio
city: Hazelton
country: United States
facility: Investigator Site
state: Pennsylvania
city: Simpsonville
country: United States
facility: Investigator Site
state: South Carolina
city: Kingsport
country: United States
facility: Investigator Site
state: Tennessee
city: Knoxville
country: United States
facility: Investigator Site
state: Tennessee
city: Nashville
country: United States
facility: Investigator Site
state: Tennessee
city: San Antonio
country: United States
facility: Investigator Site
state: Texas
city: Webster
country: United States
facility: Investigator Site
state: Texas
city: West Jordan
country: United States
facility: Investigator Site
state: Utah
Study officials:
References: