Safety and Efficacy of MBI 226 2.5% and 5.0% Topical Acne Solutions in the Treatment of Acne

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00211523

Enrollment

Registered

2005-09-21

Start date

2000-10-31

Completion date

2001-09-30

Last updated

2005-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne, Acne Vulgaris, Propionibacterium Acnes

Keywords

acne, acne vulgaris, MBI 226, Propionibacterium acnes, lesion counts, lesions, inflammatory, non-inflammatory, topical

Brief summary

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.

Interventions

DRUGMBI 226 Acne Solutions

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

13 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
- percent change in inflammatory, non-inflammatory, and total acne lesion counts over entire study and dichotomized Global Severity Assessment	—

Secondary

Measure	Time frame
- percent change in lesion counts after ~2 and ~4 weeks	—
- Global Severity Assessment	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026