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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Rosacea

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Clinical Success

Outcome Description:

A patient is considered a clinical success if the IGE is 0 (Clear)or 1 (Almost Clear)

Outcome Time Frame:

Day 70

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

MTZG 1101

NCT ID:

NCT01513863

Start Date:

August 2011

Completion Date:

August 2012

Related Keywords:

  • Rosacea
  • Rosacea

Name

Location

Center For Clinical StudiesHouston, Texas  77030
Dermatology Associates of Kingsport, PCKingsport, Tennessee  37660
Dermatology Associates Of KnoxvilleKnoxville, Tennessee  37917
Altman Dermatology AssociatesArlington Heights, Illinois  60004
North Florida Dermatology AssociatesJacksonville, Florida  
FXM Research Corp.Miami, Florida  
International Dermatology Research, Inc.Miami, Florida  
Dermatology Consulting ServicesHigh Point, North Carolina  
Las Vegas Skin & Cancer ClinicLas Vegas, Nevada  89129
The Indiana Clinical Trials Center, PCPlainfield, Indiana  46168
FXM Research MiramarMiramar, Florida  33027
Elite Clinical Studies, LLCPhoenix, Arizona  85018
Alliance Research CenterLong Beach, California  90813
Silverberg Surgical and Medical GroupNewport Beach, California  92660
Horizon Clinical Research CenterDenver, Colorado  80220
PMG Research of Hickory, LLCHickory, North Carolina  28602
New Hanover Medical Research PMGWilmington, North Carolina  28401
Haber Dermatology and Cosmetic Surgery, Inc.South Euclid, Ohio  44118
Dermatology Centers of NE PAHazelton, Pennsylvania  18201
Marshall Shuler, MDSimpsonville, South Carolina  29681
Tennessee Clinical ResearchNashville, Tennessee  37215
Dermatology San AntonioSan Antonio, Texas  78229
South Valley DermatologyWest Jordan, Utah  84088