A Study to Evaluate the Safety and Efficacy of Omiganan (CLS001) Topical Gel Versus Vehicle in Female Subjects With Moderate to Severe Acne Vulgaris



Status:Recruiting
Conditions:Acne, Acne, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:12 - Any
Updated:4/21/2016
Start Date:October 2015
End Date:November 2016
Contact:Laura Epelbaum
Email:l.epelbaum@prosoftclinical.com

Use our guide to learn which trials are right for you!

A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Multicenter Study to Evaluate the Safety and Efficacy of CLS001 Topical Gel Versus Vehicle Applied Once Daily for 12 Weeks to Female Subjects With Moderate to Severe Acne Vulgaris

The primary objective of this study is to evaluate the safety and efficacy of Omiganan
(CLS001) topical gel compared to vehicle topical gel applied once daily for 12 weeks in
female subjects with moderate to severe inflammatory acne vulgaris.


Inclusion Criteria:

- Non-pregnant female subjects ≥ 12 years of age with facial acne vulgaris

- Subjects with an Investigator's Global Assessment (IGA) of Inflammatory Lesions of
Acne Vulgaris of Moderate (3) or Severe (4) at Baseline.

- Subjects with ≥ 30 facial inflammatory lesions

Exclusion Criteria:

- Subjects with < 10 or > 75 facial non-inflammatory lesions

- Subjects with > 3 facial nodular or cystic lesions at Baseline

- Standard exclusion criteria
We found this trial at
29
sites
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
?
mi
from
Arlington, TX
Click here to add this to my saved trials
?
mi
from
Austin, TX
Click here to add this to my saved trials
?
mi
from
Beverly, MA
Click here to add this to my saved trials
?
mi
from
Boca Raton, FL
Click here to add this to my saved trials
?
mi
from
Boynton Beach, FL
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
?
mi
from
Fort Gratiot, MI
Click here to add this to my saved trials
?
mi
from
High Point, NC
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Mobile, AL
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Newington, NH
Click here to add this to my saved trials
?
mi
from
Pflugerville, TX
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
mi
from
Pinellas Park, FL
Click here to add this to my saved trials
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
?
mi
from
Sanford, FL
Click here to add this to my saved trials
?
mi
from
Santa Ana, CA
Click here to add this to my saved trials
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
?
mi
from
Spokane, WA
Click here to add this to my saved trials
?
mi
from
St. Louis, MO
Click here to add this to my saved trials
?
mi
from
Stony Brook, NY
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Webster, TX
Click here to add this to my saved trials