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

Sponsor

Maruho Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT02571998

Collaborator

(none)

320

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: Omiganan (CLS001) Topical Gel Drug: Vehicle Topical Gel	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

320 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2015

Actual Primary Completion Date :

Aug 1, 2016

Actual Study Completion Date :

Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Omiganan (CLS001) Topical Gel applied once daily	Drug: Omiganan (CLS001) Topical Gel
Placebo Comparator: Vehicle Gel Vehicle Topical Gel applied once daily	Drug: Vehicle Topical Gel

Arm

Intervention/Treatment

Experimental: Treatment

Omiganan (CLS001) Topical Gel applied once daily

Drug: Omiganan (CLS001) Topical Gel

Placebo Comparator: Vehicle Gel

Vehicle Topical Gel applied once daily

Drug: Vehicle Topical Gel

Outcome Measures

Primary Outcome Measures

Absolute change from baseline in inflammatory lesion counts at week 12 [12 weeks]

Secondary Outcome Measures

Absolute change from Baseline at each visit in inflammatory lesions, non-inflammatory lesions, and total lesions [12 weeks]
Percentage of subjects with at least a two grade reduction in the IGA of Inflammatory Lesions of Acne Vulgaris at each visit [12 weeks]
Percentage of subjects with an IGA of Inflammatory Lesions of Acne Vulgaris of clear or almost clear (0 or 1) at each visit [12 weeks]
Percentage of subjects with an IGA of Inflammatory Lesions of Acne Vulgaris of clear or almost clear (0 or 1) and at least a two grade reduction in the IGA of Inflammatory Lesions of Acne Vulgaris at each visit. [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	State	Country
1	Mobile	Alabama	United States
2	Phoenix	Arizona	United States
3	Santa Ana	California	United States
4	Santa Monica	California	United States
5	Denver	Colorado	United States
6	Boca Raton	Florida	United States
7	Boynton Beach	Florida	United States
8	Miami	Florida	United States
9	Pinellas Park	Florida	United States
10	Sanford	Florida	United States
11	Tampa	Florida	United States
12	Beverly	Massachusetts	United States
13	Fort Gratiot	Michigan	United States
14	St. Louis	Missouri	United States
15	Las Vegas	Nevada	United States
16	Newington	New Hampshire	United States
17	Albuquerque	New Mexico	United States
18	New York	New York	United States
19	Stony Brook	New York	United States
20	High Point	North Carolina	United States
21	Raleigh	North Carolina	United States
22	Knoxville	Tennessee	United States
23	Arlington	Texas	United States
24	Austin	Texas	United States
25	Pflugerville	Texas	United States
26	San Antonio	Texas	United States
27	Webster	Texas	United States
28	Salt Lake City	Utah	United States
29	Spokane	Washington	United States

Sponsors and Collaborators

Maruho Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maruho Co., Ltd.

ClinicalTrials.gov Identifier:

NCT02571998

Other Study ID Numbers:

CLS001-CO-PR-009

First Posted:

Oct 8, 2015

Last Update Posted:

Mar 27, 2017

Last Verified:

Mar 1, 2017

Additional relevant MeSH terms:

Acne Vulgaris

Study Results

No Results Posted as of Mar 27, 2017