Study to Evaluate the Long-term Safety of a Once-Daily Omiganan Topical Gel

• Sponsor: Maruho Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02576847
• Collaborator: (none)
• Enrollment: 307
• Locations: 28
• Arm: 1
• Actual Duration (Months): 28.3
• Patients Per Site: 11
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

This study evaluates the long-term safety of once-daily application of Omiganan topical gel in subjects with severe papulopustular rosacea.

Condition or Disease	Intervention/Treatment	Phase
Rosacea	Drug: Omiganan	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 307 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 3 Open-Label Extension Study to Evaluate the Long-Term Safety of Omiganan Topical Gel in Subjects With Rosacea
• Actual Study Start Date: Oct 1, 2015
• Actual Primary Completion Date: Jul 14, 2017
• Actual Study Completion Date: Feb 8, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Omiganan gel applied once daily	Drug: Omiganan; Topical gel

Outcome Measures

Primary Outcome Measures

1. Number of Subjects With 1 or More Treatment-related Treatment-Emergent Adverse Events [Up to 12 months]

   Number of subjects with 1 or more treatment-related Treatment-Emergent Adverse Events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Healthy, male and nonpregnant female subjects, 18 years of age or older.

2. A diagnosis of severe papulopustular rosacea using the Investigator Global Assessment grading scale at baseline

3. Subjects with the presence of telangiectasia at Baseline

4. Subjects with the presence of facial erythema associated with their rosacea at Baseline

Exclusion Criteria:

1. Subjects with steroid rosacea or subtype 3 (phymatous rosacea).

2. Subjects with nodular rosacea

3. Standard exclusion criteria.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Fremont	California	United States
2		Miami	Florida	United States
3		Miramar	Florida	United States
4		Tampa	Florida	United States
5		Arlington Heights	Illinois	United States
6		Carmel	Indiana	United States
7		Indianapolis	Indiana	United States
8		Plainfield	Indiana	United States
9		Watertown	Massachusetts	United States
10		Albuquerque	New Mexico	United States
11		New York	New York	United States
12		Nashville	Tennessee	United States
13		Dallas	Texas	United States
14		Pflugerville	Texas	United States
15		Webster	Texas	United States
16		Sydney	New South Wales	Australia
17		Woolloongabba	Queensland	Australia
18		Vancouver	British Columbia	Canada
19		Winnipeg	Manitoba	Canada
20		Drummondville	Quebec	Canada
21		Cannes		France
22		Nice		France
23		Bergen Op Zoom		Netherlands
24		Hamilton		New Zealand
25		Wellington		New Zealand
26		Gothenburg		Sweden
27		Lanarkshire		United Kingdom
28		Manchester		United Kingdom

Sponsors and Collaborators

• Maruho Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Mar 7, 2017
• Statistical Analysis Plan - Aug 25, 2015

More Information

Publications

None provided.

• Responsible Party: Maruho Co., Ltd.
• ClinicalTrials.gov Identifier: NCT02576847
• Other Study ID Numbers: CLS001-CO-PR-006
• First Posted: Oct 15, 2015
• Last Update Posted: Jul 19, 2022
• Last Verified: Jul 1, 2022

• Additional relevant MeSH terms: Rosacea

Study Results

Participant Flow

Recruitment Details	The study was conducted at 28 sites in the USA, Canada, Australia/New Zealand, and Europe from October 2015 to July 2017.

Arm/Group Title	Treatment
Arm/Group Description	Omiganan gel applied once daily Omiganan: Topical gel
Period Title: Overall Study
STARTED	307
COMPLETED	170
NOT COMPLETED	137

Baseline Characteristics

Arm/Group Title	Treatment
Arm/Group Description	Omiganan gel applied once daily Omiganan: Topical gel
Overall Participants	307
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	243 79.2%
>=65 years	64 20.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.5 (13.57)
Sex: Female, Male (Count of Participants)
Female	205 66.8%
Male	102 33.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	80 26.1%
Not Hispanic or Latino	227 73.9%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 0.7%
Asian	5 1.6%
Native Hawaiian or Other Pacific Islander	1 0.3%
Black or African American	1 0.3%
White	286 93.2%
More than one race	0 0%
Unknown or Not Reported	12 3.9%
Region of Enrollment (participants) [Number]
New Zealand	34 11.1%
Canada	24 7.8%
Netherlands	1 0.3%
United States	187 60.9%
United Kingdom	6 2%
Australia	37 12.1%
France	18 5.9%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects With 1 or More Treatment-related Treatment-Emergent Adverse Events
Description	Number of subjects with 1 or more treatment-related Treatment-Emergent Adverse Events
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment
Arm/Group Description	Omiganan gel applied once daily Omiganan: Topical gel
Measure Participants	307
Number [participants]	48 15.6%

Adverse Events

Time Frame	378 Days
Arm/Group Title	Treatment
Arm/Group Description	Omiganan gel applied once daily Omiganan: Topical gel
All Cause Mortality
	Treatment
	Affected / at Risk (%)	# Events
Total	0/307 (0%)
Serious Adverse Events
	Treatment
	Affected / at Risk (%)	# Events
Total	7/307 (2.3%)
Gastrointestinal disorders
Abdominal pain upper	1/307 (0.3%)	1
Injury, poisoning and procedural complications
Post concussion syndrome	1/307 (0.3%)	1
Metabolism and nutrition disorders
Diabetic ketoacidosis	1/307 (0.3%)	1
Dehydration	1/307 (0.3%)	1
Nervous system disorders
Dizziness	1/307 (0.3%)	1
Respiratory, thoracic and mediastinal disorders
Apnoeic attack	1/307 (0.3%)	1
Epistaxis	1/307 (0.3%)	1
Other (Not Including Serious) Adverse Events
	Treatment
	Affected / at Risk (%)	# Events
Total	83/307 (27%)
General disorders
Application site pain	10/307 (3.3%)	12
Application site erythema	8/307 (2.6%)	8
Application site dryness	7/307 (2.3%)	7
Infections and infestations
Viral upper respiratory tract infection	12/307 (3.9%)	13
Upper respiratory tract infection	9/307 (2.9%)	14
Nervous system disorders
Headache	16/307 (5.2%)	34
Skin and subcutaneous tissue disorders
Rosacea	21/307 (6.8%)	28

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.