Safety and Efficacy of MBI 226 1.25% and 2.5% Topical Acn... | NCT00211497

Studies
Safety and Efficacy of MBI 226 1.25% and 2.5% Topical Acne Solutions in the Treatment of Acne

NCT00211497

Sponsor

BioWest Therapeutics Inc

Status

Completed

Last Update Posted

Sep 21, 2005Estimated

Enrollment

255

Phase

Phase 2

Conditions

Acne Vulgaris
Acne
Propionibacterium Acnes

Interventions

MBI 226 Acne Solutions

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jan 2003

Primary Completion Date

Not provided

Completion Date

Sep 2003

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2005

Last Update Posted Date

Sep 21, 2005Estimated

Description Module

Brief Summary

This is a Phase II, randomized, vehicle-controlled, double-blind, multi center study to evaluate the efficacy and safety of topically applied MBI 226 1.25% and 2.5% Acne Solutions as anti-acne preparations in human subjects with facial acne vulgaris.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

255

Name	Type	Description	Arm Group Labels	Other Names
MBI 226 Acne Solutions	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
- percent change from Baseline to Week 12 in inflammatory acne lesion counts

Secondary Outcomes

Measure	Description	Time Frame
Single continuous endpoints:
• Percent change from Baseline to Week 6 and Week 12 in non inflammatory acne lesion counts
• The percent change from Baseline to Week 6 and Week 12 in total acne lesion counts

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and females 12 years and older
Presence of inflammatory and non-inflammatory lesions

Exclusion Criteria:

Acne conglobata, acne fulminans, or secondary acne (chloracne, drug-induced acne, etc.)
Active facial cysts or any nodulocystic lesions

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Jim Pankovich	BioWest Therapeutics Inc	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D000152	Acne Vulgaris

Ancestor Terms

ID	Term
D017486	Acneiform Eruptions
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012625	Sebaceous Gland Diseases

Browse Leaves

Not provided

Browse Branches

Not provided