NCT01513863CompletedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Taro Pharmaceuticals USA
- Enrollment
- 602
- Locations
- 1
- Primary Endpoint
- Clinical Success
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or non-pregnant, non-lactating female, 18 years of age or older.
- •Signed informed consent form, which meets all criteria of current FDA regulations.
- •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).
- •Have moderate to severe facial rosacea.
- •Have a Baseline Investigator Global Evaluation Score of 3 or 4.
Exclusion Criteria
- •Mild facial rosacea (less than 8 inflammatory lesions on the face) or very severe rosacea (more than 50 inflammatory lesions)
- •Patients with excessive facial hair (beards, sideburns, moustaches, etc.) that would interfere with the diagnosis or assessment of rosacea.
- •History of hypersensitivity or allergy to Metronidazole, or other ingredients of the formulation.
- •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.
- •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
- •The use of anticoagulant therapy within 14 days prior to baseline.
- •The use of any antipruritics, including antihistamines within 24 hours of any study visits.
- •History of blood dyscrasia.
- •Ocular rosacea (e.g., conjunctivitis, blepharitis, keratitis) of sufficient severity to require topical or systemic antibiotics.
- •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).
- •Females who are pregnant, lactating or likely to become pregnant during the study.
- •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.
- •Any Patient (male or female) who has started, or changed hormonal therapy within 3 months of the Baseline visit (this includes hormonal contraceptives).
- •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.
- •Receipt of any drug as part of a research study within 30 days prior to dosing.
- •Employees of the research center or Investigator.
- •Previous participation in this study.
Arms & Interventions
Metronidazole Topical Gel 1% (Metrogel )
Active Comparator
Intervention: Metronidazole Topical Gel 1% (Metrogel) (Drug)
Metronidazole Topical Gel 1%
Experimental
Intervention: Metronidazole Topical Gel 1% (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Clinical Success
Time Frame: Day 70
A patient is considered a clinical success if the IGE is 0 (Clear)or 1 (Almost Clear)
Treatment Success
Time Frame: Day 70
A patient is considered a treatment success if the mean percent change from baseline at week 10 (Day 70) in the inflammatory (papules and pastales) lesion count of Rosacea
Secondary Outcomes
- Change in Investigational Global Evaluation (IGE)(Day 70)
Investigators
Study Sites (1)
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