Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle

• Sponsor: Maruho Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02547441
• Collaborator: (none)
• Enrollment: 463
• Locations: 41
• Arms: 2
• Actual Duration (Months): 28.4
• Patients Per Site: 11.3
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

This study evaluates the safety and efficacy of once-daily application of CLS001 topical gel compared to vehicle gel in subjects with severe papulopustular rosacea.

Condition or Disease	Intervention/Treatment	Phase
Rosacea	Drug: CLS001 (Omiganan); Drug: Vehicle	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 463 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Randomized, Vehicle-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle Administered for 12 Weeks to Subjects With Papulopustular Rosacea With an Open-Label Safety Extension
• Actual Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Jul 5, 2017
• Actual Study Completion Date: Apr 13, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in Inflammatory Lesion Count From Baseline to Week 12 [12 weeks]

   Change from Baseline to Week 12 in Inflammatory Lesion Count

2. Percentage of Participants Who Achieved 2 Grade IGA Reduction. [12 weeks]

   Percentage of participants who achieved 2 grade IGA reduction at Week 12. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).

Secondary Outcome Measures

1. Change in the Number of Inflammatory Lesions From Baseline at Week 9 [9 weeks]

   The absolute change in inflammatory lesions from baseline to Week 9

2. Change in the Number of Inflammatory Lesions From Baseline at Week 6 [6 weeks]

   The absolute change in inflammatory lesions from baseline to Week 6

3. Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 9. [9 Weeks]

   Percentage of participants who achieved 2 grade IGA reduction at Week 9. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).

4. Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 6. [6 Weeks]

   Percentage of participants who achieved 2 grade IGA reduction at Week 6. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).

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 non-pregnant female subjects, 18 years of age or older.

2. A diagnosis of papulopustular rosacea with ≥30 inflammatory facial lesions at Baseline. Subjects must have no more than 2 nodular lesions, at Baseline.

3. Subjects with the presence of telangiectasia at Baseline.

4. Subjects with an erythema score of at least 2 on the Investigator Assessment of Erythema scale at Baseline.

5. Subjects with severe rosacea on the Investigators Global Assessment scale 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		Fort Gratiot	Michigan	United States
8		Albuquerque	New Mexico	United States
9		New York	New York	United States
10		Stony Brook	New York	United States
11		Dallas	Texas	United States
12		San Antonio	Texas	United States
13		Charlottesville	Virginia	United States
14		Woolloongabba	Queensland	Australia
15		Carlton	Victoria	Australia
16		East Melbourne	Victoria	Australia
17		Hamilton	Ontario	Canada
18		Toronto	Ontario	Canada
19		Brest		France
20		Nancy		France
21		Nice		France
22		Rouen		France
23		Thionville		France
24		Augsburg		Germany
25		Berlin		Germany
26		Bochum		Germany
27		Darmstadt		Germany
28		Dresden		Germany
29		Dulmen		Germany
30		Frankfurt		Germany
31		Ibbenbueren		Germany
32		Lubeck		Germany
33		Mahlow		Germany
34		Munster		Germany
35		Rotterdam		Netherlands
36		Hamilton		New Zealand
37		Gothenburg		Sweden
38		Lanarkshire		United Kingdom
39		Leeds		United Kingdom
40		Manchester		United Kingdom
41		Surrey		United Kingdom

Sponsors and Collaborators

• Maruho Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Mar 31, 2017
• Statistical Analysis Plan - Jun 29, 2017

More Information

Publications

None provided.

• Responsible Party: Maruho Co., Ltd.
• ClinicalTrials.gov Identifier: NCT02547441
• Other Study ID Numbers: CLS001-CO-PR-004
• First Posted: Sep 11, 2015
• Last Update Posted: Aug 2, 2022
• Last Verified: Jul 1, 2022

• Additional relevant MeSH terms: Rosacea

Study Results

Participant Flow

Recruitment Details	The study was conducted at 42 sites in the USA, Canada, Australia/New Zealand, and Europe from December 2015 to July 2017.

Arm/Group Title	CLS001 (Omiganan) Gel	Vehicle Gel
Arm/Group Description	CLS001 (Omiganan) gel applied once daily CLS001 (Omiganan): Topical gel	Vehicle gel applied once daily Vehicle: Vehicle Gel
Period Title: Double-Blind Study Period
STARTED	235	228
COMPLETED	211	196
NOT COMPLETED	24	32
Period Title: Double-Blind Study Period
STARTED	188	175
COMPLETED	66	48
NOT COMPLETED	122	127

Baseline Characteristics

Arm/Group Title	Treatment	Vehicle Gel	Total
Arm/Group Description	CLS001 (Omiganan) gel applied once daily CLS001 (Omiganan): Topical gel	Vehicle gel applied once daily Vehicle: Vehicle Gel	Total of all reporting groups
Overall Participants	235	228	463
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	203 86.4%	193 84.6%	396 85.5%
>=65 years	32 13.6%	35 15.4%	67 14.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.4 (13.06)	51.6 (12.16)	51 (12.63)
Sex: Female, Male (Count of Participants)
Female	159 67.7%	137 60.1%	296 63.9%
Male	76 32.3%	91 39.9%	167 36.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	43 18.3%	37 16.2%	80 17.3%
Not Hispanic or Latino	192 81.7%	191 83.8%	383 82.7%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.4%	2 0.9%	3 0.6%
Asian	8 3.4%	2 0.9%	10 2.2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	222 94.5%	221 96.9%	443 95.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	4 1.7%	3 1.3%	7 1.5%
Region of Enrollment (participants) [Number]
New Zealand	6 2.6%	7 3.1%	13 2.8%
Canada	25 10.6%	26 11.4%	51 11%
Netherlands	3 1.3%	4 1.8%	7 1.5%
Sweden	10 4.3%	9 3.9%	19 4.1%
United States	81 34.5%	73 32%	154 33.3%
United Kingdom	8 3.4%	9 3.9%	17 3.7%
Australia	23 9.8%	21 9.2%	44 9.5%
France	13 5.5%	11 4.8%	24 5.2%
Germany	66 28.1%	68 29.8%	134 28.9%
Fitzpatrick Skin Type (Count of Participants)
I - Always burn, never tan	29 12.3%	31 13.6%	60 13%
II - Usually burn, tans less than average (with difficulty)	97 41.3%	106 46.5%	203 43.8%
III - Sometimes mild burn, tans less than average	79 33.6%	71 31.1%	150 32.4%
IV - Rarely burn, tan more than average (with ease)	28 11.9%	15 6.6%	43 9.3%
V - Rarely burns, tans profusely	2 0.9%	5 2.2%	7 1.5%
VI - Never burns, tans profusely	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Change in Inflammatory Lesion Count From Baseline to Week 12
Description	Change from Baseline to Week 12 in Inflammatory Lesion Count
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

The 'Intent-to-treat' (ITT) analysis population included all randomized subjects.

Arm/Group Title	Treatment	Vehicle Gel
Arm/Group Description	CLS001 (Omiganan) gel applied once daily CLS001 (Omiganan): Topical gel	Vehicle gel applied once daily Vehicle: Vehicle Gel
Measure Participants	235	228
Least Squares Mean (Standard Error) [Lesions]	-18.1 (1.77)	-13.5 (1.85)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Treatment, Vehicle Gel
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.043
	Comments
	Method	ANCOVA
	Comments

2. Primary Outcome

Title	Percentage of Participants Who Achieved 2 Grade IGA Reduction.
Description	Percentage of participants who achieved 2 grade IGA reduction at Week 12. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

The 'Intent-to-treat' (ITT) analysis population included all randomized subjects.

Arm/Group Title	Treatment	Vehicle Gel
Arm/Group Description	CLS001 (Omiganan) gel applied once daily CLS001 (Omiganan): Topical gel	Vehicle gel applied once daily Vehicle: Vehicle Gel
Measure Participants	235	228
Number [Percentage of Participants]	26.3 11.2%	16.9 7.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Treatment, Vehicle Gel
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.019
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

3. Secondary Outcome

Title	Change in the Number of Inflammatory Lesions From Baseline at Week 9
Description	The absolute change in inflammatory lesions from baseline to Week 9
Time Frame	9 weeks

Outcome Measure Data

Analysis Population Description

The 'Intent-to-treat' (ITT) analysis population included all randomized subjects.

Arm/Group Title	Treatment	Vehicle Gel
Arm/Group Description	CLS001 (Omiganan) gel applied once daily CLS001 (Omiganan): Topical gel	Vehicle gel applied once daily Vehicle: Vehicle Gel
Measure Participants	235	228
Least Squares Mean (Standard Error) [Lesions]	-17.4 (1.55)	-15.2 (1.60)

4. Secondary Outcome

Title	Change in the Number of Inflammatory Lesions From Baseline at Week 6
Description	The absolute change in inflammatory lesions from baseline to Week 6
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

The 'Intent-to-treat' (ITT) analysis population included all randomized subjects.

Arm/Group Title	Treatment	Vehicle Gel
Arm/Group Description	CLS001 (Omiganan) gel applied once daily CLS001 (Omiganan): Topical gel	Vehicle gel applied once daily Vehicle: Vehicle Gel
Measure Participants	235	228
Least Squares Mean (Standard Error) [Lesions]	-13.5 (1.44)	-11.8 (1.48)

5. Secondary Outcome

Title	Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 9.
Description	Percentage of participants who achieved 2 grade IGA reduction at Week 9. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).
Time Frame	9 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment	Vehicle Gel
Arm/Group Description	CLS001 (Omiganan) gel applied once daily CLS001 (Omiganan): Topical gel	Vehicle gel applied once daily Vehicle: Vehicle Gel
Measure Participants	235	228
Number [Percentage of Participants]	18.4 7.8%	14.4 6.3%

6. Secondary Outcome

Title	Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 6.
Description	Percentage of participants who achieved 2 grade IGA reduction at Week 6. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).
Time Frame	6 Weeks

Outcome Measure Data

Analysis Population Description

The 'Intent-to-treat' (ITT) analysis population included all randomized subjects.

Arm/Group Title	Treatment	Vehicle Gel
Arm/Group Description	CLS001 (Omiganan) gel applied once daily CLS001 (Omiganan): Topical gel	Vehicle gel applied once daily Vehicle: Vehicle Gel
Measure Participants	235	228
Number [Percentage of Participants]	13.8 5.9%	8.9 3.9%

Adverse Events

Time Frame	12-week in Double-Blind Period and maximum 1 year in Open-Label Period
Arm/Group Title	CLS001 (Omiganan) Gel (Double-Blind Period)		Vehicle Gel (Double-Blind Period)		CLS001 (Omiganan) Gel (Open-Label Period)
Arm/Group Description	CLS001 (Omiganan) topical gel applied once daily for 12-week		Vehicle topical gel applied once daily for 12-week		CLS001 (Omiganan) topical gel applied once daily for maximum 1-year
All Cause Mortality
	CLS001 (Omiganan) Gel (Double-Blind Period)		Vehicle Gel (Double-Blind Period)		CLS001 (Omiganan) Gel (Open-Label Period)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/235 (0%)		0/228 (0%)		0/363 (0%)
Serious Adverse Events
	CLS001 (Omiganan) Gel (Double-Blind Period)		Vehicle Gel (Double-Blind Period)		CLS001 (Omiganan) Gel (Open-Label Period)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/235 (1.7%)		4/228 (1.8%)		8/363 (2.2%)
Cardiac disorders
Coronary artery disease	1/235 (0.4%)	1	0/228 (0%)	0	0/363 (0%)	0
General disorders
Chest pain	1/235 (0.4%)	1	0/228 (0%)	0	0/363 (0%)	0
Hepatobiliary disorders
Cholecystitis acute	1/235 (0.4%)	2	0/228 (0%)	0	1/363 (0.3%)	1
Infections and infestations
Acute cellulitis	0/235 (0%)	0	0/228 (0%)	0	1/363 (0.3%)	1
Injury, poisoning and procedural complications
Achilles tendon rupture left	0/235 (0%)	0	0/228 (0%)	0	1/363 (0.3%)	1
Musculoskeletal and connective tissue disorders
Costochondritis	0/235 (0%)	0	1/228 (0.4%)	1	0/363 (0%)	0
Intervertebral disc protrusion	0/235 (0%)	0	1/228 (0.4%)	1	0/363 (0%)	0
Herniated vertebral disc (cervical spine)	0/235 (0%)	0	0/228 (0%)	0	1/363 (0.3%)	1
Primary gonarthrosis left	0/235 (0%)	0	0/228 (0%)	0	1/363 (0.3%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland neoplasm	0/235 (0%)	0	1/228 (0.4%)	1	0/363 (0%)	0
B-cell non hodgkin lymphoma	0/235 (0%)	0	0/228 (0%)	0	1/363 (0.3%)	1
Melanoma in situ of the lentigo maligna type, level 1	0/235 (0%)	0	0/228 (0%)	0	1/363 (0.3%)	1
Renal carcinoma	0/235 (0%)	0	0/228 (0%)	0	1/363 (0.3%)	1
Nervous system disorders
Seizures	1/235 (0.4%)	1	0/228 (0%)	0	0/363 (0%)	0
Presyncope	0/235 (0%)	0	1/228 (0.4%)	1	0/363 (0%)	0
Other (Not Including Serious) Adverse Events
	CLS001 (Omiganan) Gel (Double-Blind Period)		Vehicle Gel (Double-Blind Period)		CLS001 (Omiganan) Gel (Open-Label Period)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	83/235 (35.3%)		83/228 (36.4%)		116/363 (32%)
Gastrointestinal disorders
Nausea	5/235 (2.1%)	5	2/228 (0.9%)	2	1/363 (0.3%)	1
Diarrhoea	3/235 (1.3%)	5	5/228 (2.2%)	5	3/363 (0.8%)	3
General disorders
Application site dermatitis	5/235 (2.1%)	5	1/228 (0.4%)	1	5/363 (1.4%)	5
Application site pain	5/235 (2.1%)	7	8/228 (3.5%)	9	6/363 (1.7%)	6
Application site pruritus	5/235 (2.1%)	5	2/228 (0.9%)	2	2/363 (0.6%)	2
Application site erythema	4/235 (1.7%)	4	7/228 (3.1%)	8	5/363 (1.4%)	6
Application site dryness	2/235 (0.9%)	3	5/228 (2.2%)	5	5/363 (1.4%)	5
Infections and infestations
Viral upper respiratory tract infection	18/235 (7.7%)	18	22/228 (9.6%)	23	41/363 (11.3%)	57
Upper respiratory tract infection	14/235 (6%)	17	4/228 (1.8%)	4	13/363 (3.6%)	15
Musculoskeletal and connective tissue disorders
Back pain	2/235 (0.9%)	2	5/228 (2.2%)	5	2/363 (0.6%)	2
Nervous system disorders
Headache	18/235 (7.7%)	24	14/228 (6.1%)	24	19/363 (5.2%)	27
Skin and subcutaneous tissue disorders
Rosacea	2/235 (0.9%)	2	8/228 (3.5%)	8	14/363 (3.9%)	17

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.