Please note that the ANZCTR website will be unavailable from 9am until 9.30am (AEST) on Monday 22nd July for website maintenance. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02576860




Registration number
NCT02576860
Ethics application status
Date submitted
13/10/2015
Date registered
15/10/2015
Date last updated
2/03/2018

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 Once-Daily CLS001 Topical Gel Versus Vehicle Administered for 12 Weeks to Subjects With Papulopustular Rosacea With a 4 Week Follow-up Period
Secondary ID [1] 0 0
CLS001-CO-PR-005
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 (Omignan) 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
Efficacy Absolute change in inflammatory lesion count - Absolute change in inflammatory lesion count
Timepoint [1] 0 0
12 weeks
Primary outcome [2] 0 0
Efficacy IGA: 2 grade reduction - IGA: 2 grade reduction; Clear or almost clear
Timepoint [2] 0 0
12 weeks
Primary outcome [3] 0 0
Safety Adverse events - Adverse events
Timepoint [3] 0 0
12 weeks
Secondary outcome [1] 0 0
Efficacy The absolute change in inflammatory lesions - The absolute change in inflammatory lesions
Timepoint [1] 0 0
9 weeks
Secondary outcome [2] 0 0
Efficacy The absolute change in inflammatory lesions - The absolute change in inflammatory lesions
Timepoint [2] 0 0
6 weeks
Secondary outcome [3] 0 0
Efficacy IGA: 2 point reduction - IGA: 2 point reduction; Clear or almost clear
Timepoint [3] 0 0
9 Weeks
Secondary outcome [4] 0 0
Efficacy IGA: 2 point reduction - IGA: 2 point reduction; Clear or almost clear
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW
Recruitment hospital [1] 0 0
- Phillip
Recruitment hospital [2] 0 0
- Kogarah
Recruitment hospital [3] 0 0
- Liverpool
Recruitment hospital [4] 0 0
- Victoria
Recruitment postcode(s) [1] 0 0
- Phillip
Recruitment postcode(s) [2] 0 0
- Kogarah
Recruitment postcode(s) [3] 0 0
- Liverpool
Recruitment postcode(s) [4] 0 0
- Victoria
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Nebraska
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
South Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
Canada
State/province [14] 0 0
British Columbia
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
France
State/province [16] 0 0
Grenoble
Country [17] 0 0
France
State/province [17] 0 0
Nantes
Country [18] 0 0
France
State/province [18] 0 0
Quimper
Country [19] 0 0
Germany
State/province [19] 0 0
Berlin
Country [20] 0 0
Germany
State/province [20] 0 0
Bochum
Country [21] 0 0
Germany
State/province [21] 0 0
Bonn
Country [22] 0 0
Germany
State/province [22] 0 0
Friedrichshafen
Country [23] 0 0
Germany
State/province [23] 0 0
Hamburg
Country [24] 0 0
Germany
State/province [24] 0 0
Koeln
Country [25] 0 0
Germany
State/province [25] 0 0
Lingen
Country [26] 0 0
Germany
State/province [26] 0 0
Monchengladbach
Country [27] 0 0
Germany
State/province [27] 0 0
Osnabruck
Country [28] 0 0
Germany
State/province [28] 0 0
Schweinfurt
Country [29] 0 0
Netherlands
State/province [29] 0 0
Nijmegen
Country [30] 0 0
New Zealand
State/province [30] 0 0
Auckland
Country [31] 0 0
Sweden
State/province [31] 0 0
Halmstad
Country [32] 0 0
United Kingdom
State/province [32] 0 0
England
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Birmingham
Country [34] 0 0
United Kingdom
State/province [34] 0 0
London

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/show/NCT02576860
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

Summary results
Other publications