- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00211523
Safety and Efficacy of MBI 226 2.5% and 5.0% Topical Acne Solutions in the Treatment of Acne
September 13, 2005 updated by: BioWest Therapeutics Inc
Phase II, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of MBI 226 2.5% and 5.0% Acne Solutions Applied Topically for 6 Weeks to Subjects With Acne Vulgaris
This study investigates the safety and efficacy of MBI 226 2.5% and 5.0% Acne Solutions, applied topically for six weeks, in the treatment of acne.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
75
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males and females, ages 13 and up, exhibiting high levels of facial P. acnes
- Presence of inflammatory and non-inflammatory lesions
Exclusion Criteria:
- Acne conglobata, acne fulminans, or secondary acne (chlorine, drug-induced acne, etc.)
- Active facial cysts
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
- percent change in inflammatory, non-inflammatory, and total acne lesion counts over entire study and dichotomized Global Severity Assessment
|
Secondary Outcome Measures
Outcome Measure |
---|
- percent change in lesion counts after ~2 and ~4 weeks
|
- Global Severity Assessment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jim Pankovich, BioWest Therapeutics Inc
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2000
Study Completion
September 1, 2001
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 21, 2005
Study Record Updates
Last Update Posted (Estimate)
September 21, 2005
Last Update Submitted That Met QC Criteria
September 13, 2005
Last Verified
September 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A99004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acne Vulgaris
-
Galderma R&DCompletedSevere Acne VulgarisUnited States, Canada, Puerto Rico
-
Sebacia, Inc.CompletedInflammatory Acne VulgarisUnited States
-
Nexgen Dermatologics, Inc.Unknown
-
Rejuva Medical AestheticsHealMD, LLCNot yet recruitingAcne Vulgaris (Disorder)United States
-
InMode MD Ltd.Active, not recruitingInflammatory Acne VulgarisUnited States
-
PollogenLumenis Be Ltd.RecruitingModerate to Severe Acne VulgarisUnited States
-
Boston PharmaceuticalsCompletedModerate to Severe Acne VulgarisUnited States, Canada
-
Bispebjerg HospitalCompleted
-
Actavis Mid-Atlantic LLCCompletedMILD TO SEVERE ACNE VULGARISIndia
-
Assiut UniversityCompleted
Clinical Trials on MBI 226 Acne Solutions
-
BioWest Therapeutics IncCompletedAcne Vulgaris | Acne | Propionibacterium Acnes
-
BioWest Therapeutics IncCompletedSepsis | Fungemia | BacteremiaUnited States
-
Biocruces Bizkaia Health Research InstituteSociedad Espanola de Angiologia y Cirugia VascularRecruitingAnemia | Peripheral Arterial Occlusive DiseaseSpain
-
Sanofi Pasteur, a Sanofi CompanyRecruiting
-
Chang Gung Memorial HospitalRecruiting
-
Northwestern UniversityCompleted
-
Jinnah Postgraduate Medical CentreCompleted
-
The Skin Center Dermatology GroupRecruitingWarts | Tinea | Actinic Keratosis | Bowen's Disease | Molluscum Contagiosum | Acne/Rosacea | Verruca PlanaUnited States
-
Aalborg UniversityRecruitingSleep Deprivation | Histamine | CowhageDenmark
-
Seoul National University HospitalCompleted