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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02547441




Registration number
NCT02547441
Ethics application status
Date submitted
9/09/2015
Date registered
11/09/2015
Date last updated
2/08/2022

Titles & IDs
Public title
Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle
Scientific 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
Secondary ID [1] 0 0
CLS001-CO-PR-004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rosacea 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CLS001 (Omiganan)
Treatment: Drugs - Vehicle

Experimental: Treatment - CLS001 (Omiganan) gel applied once daily

Placebo Comparator: Vehicle Gel - Vehicle gel applied once daily


Treatment: Drugs: CLS001 (Omiganan)
Topical gel

Treatment: Drugs: Vehicle
Vehicle Gel
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Inflammatory Lesion Count From Baseline to Week 12
Timepoint [1] 0 0
12 weeks
Primary outcome [2] 0 0
Percentage of Participants Who Achieved 2 Grade IGA Reduction.
Timepoint [2] 0 0
12 weeks
Secondary outcome [1] 0 0
Change in the Number of Inflammatory Lesions From Baseline at Week 9
Timepoint [1] 0 0
9 weeks
Secondary outcome [2] 0 0
Change in the Number of Inflammatory Lesions From Baseline at Week 6
Timepoint [2] 0 0
6 weeks
Secondary outcome [3] 0 0
Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 9.
Timepoint [3] 0 0
9 Weeks
Secondary outcome [4] 0 0
Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 6.
Timepoint [4] 0 0
6 Weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Subjects with steroid rosacea or subtype 3 (phymatous rosacea).

2. Subjects with nodular rosacea.

3. Standard exclusion criteria.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/04/2018
Sample size
Target
Accrual to date
Final
463
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
- Woolloongabba
Recruitment hospital [2] 0 0
- Carlton
Recruitment hospital [3] 0 0
- East Melbourne
Recruitment postcode(s) [1] 0 0
- Woolloongabba
Recruitment postcode(s) [2] 0 0
- Carlton
Recruitment postcode(s) [3] 0 0
- East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
New Mexico
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
France
State/province [11] 0 0
Brest
Country [12] 0 0
France
State/province [12] 0 0
Nancy
Country [13] 0 0
France
State/province [13] 0 0
Nice
Country [14] 0 0
France
State/province [14] 0 0
Rouen
Country [15] 0 0
France
State/province [15] 0 0
Thionville
Country [16] 0 0
Germany
State/province [16] 0 0
Augsburg
Country [17] 0 0
Germany
State/province [17] 0 0
Berlin
Country [18] 0 0
Germany
State/province [18] 0 0
Bochum
Country [19] 0 0
Germany
State/province [19] 0 0
Darmstadt
Country [20] 0 0
Germany
State/province [20] 0 0
Dresden
Country [21] 0 0
Germany
State/province [21] 0 0
Dulmen
Country [22] 0 0
Germany
State/province [22] 0 0
Frankfurt
Country [23] 0 0
Germany
State/province [23] 0 0
Ibbenbueren
Country [24] 0 0
Germany
State/province [24] 0 0
Lubeck
Country [25] 0 0
Germany
State/province [25] 0 0
Mahlow
Country [26] 0 0
Germany
State/province [26] 0 0
Munster
Country [27] 0 0
Netherlands
State/province [27] 0 0
Rotterdam
Country [28] 0 0
New Zealand
State/province [28] 0 0
Hamilton
Country [29] 0 0
Sweden
State/province [29] 0 0
Gothenburg
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Lanarkshire
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Leeds
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Manchester
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Maruho Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02547441
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries