NCT02571998

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

29 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 2, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 8, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2017

Enrollment Period

10 months

First QC Date

October 2, 2015

Last Update Submit

March 24, 2017

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

  • Absolute change from baseline in inflammatory lesion counts at week 12

    12 weeks

Secondary Outcomes (4)

  • 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

Study Arms (2)

Treatment

EXPERIMENTAL

Omiganan (CLS001) Topical Gel applied once daily

Drug: Omiganan (CLS001) Topical Gel

Vehicle Gel

PLACEBO COMPARATOR

Vehicle Topical Gel applied once daily

Drug: Vehicle Topical Gel

Interventions

Omiganan (CLS001) Topical GelDRUG
Treatment
Vehicle Topical GelDRUG
Vehicle Gel

Eligibility Criteria

Age12 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Subjects with \< 10 or \> 75 facial non-inflammatory lesions
  • Subjects with \> 3 facial nodular or cystic lesions at Baseline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

Unknown Facility

Mobile, Alabama, United States

Location

Unknown Facility

Phoenix, Arizona, United States

Location

Unknown Facility

Santa Ana, California, United States

Location

Unknown Facility

Santa Monica, California, United States

Location

Unknown Facility

Denver, Colorado, United States

Location

Unknown Facility

Boca Raton, Florida, United States

Location

Unknown Facility

Boynton Beach, Florida, United States

Location

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

Pinellas Park, Florida, United States

Location

Unknown Facility

Sanford, Florida, United States

Location

Unknown Facility

Tampa, Florida, United States

Location

Unknown Facility

Beverly, Massachusetts, United States

Location

Unknown Facility

Fort Gratiot, Michigan, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

Las Vegas, Nevada, United States

Location

Unknown Facility

Newington, New Hampshire, United States

Location

Unknown Facility

Albuquerque, New Mexico, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Stony Brook, New York, United States

Location

Unknown Facility

High Point, North Carolina, United States

Location

Unknown Facility

Raleigh, North Carolina, United States

Location

Unknown Facility

Knoxville, Tennessee, United States

Location

Unknown Facility

Arlington, Texas, United States

Location

Unknown Facility

Austin, Texas, United States

Location

Unknown Facility

Pflugerville, Texas, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Unknown Facility

Webster, Texas, United States

Location

Unknown Facility

Salt Lake City, Utah, United States

Location

Unknown Facility

Spokane, Washington, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

OmigananGels

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

ColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2015

First Posted

October 8, 2015

Study Start

October 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

March 27, 2017

Record last verified: 2017-03

Locations

US(29)