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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02576847




Registration number
NCT02576847
Ethics application status
Date submitted
13/10/2015
Date registered
15/10/2015
Date last updated
19/07/2022

Titles & IDs
Public title
Study to Evaluate the Long-term Safety of a Once-Daily Omiganan Topical Gel
Scientific title
A Phase 3 Open-Label Extension Study to Evaluate the Long-Term Safety of Omiganan Topical Gel in Subjects With Rosacea
Secondary ID [1] 0 0
CLS001-CO-PR-006
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 - Omiganan

Experimental: Treatment - Omiganan gel applied once daily


Treatment: Drugs: Omiganan
Topical gel
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Subjects With 1 or More Treatment-related Treatment-Emergent Adverse Events
Timepoint [1] 0 0
Up to 12 months

Eligibility
Key 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
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
Not applicable
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
1/10/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/02/2018
Sample size
Target
Accrual to date
Final
307
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
- Sydney
Recruitment hospital [2] 0 0
- Woolloongabba
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Woolloongabba
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
Massachusetts
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
Tennessee
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
Canada
State/province [10] 0 0
British Columbia
Country [11] 0 0
Canada
State/province [11] 0 0
Manitoba
Country [12] 0 0
Canada
State/province [12] 0 0
Quebec
Country [13] 0 0
France
State/province [13] 0 0
Cannes
Country [14] 0 0
France
State/province [14] 0 0
Nice
Country [15] 0 0
Netherlands
State/province [15] 0 0
Bergen Op Zoom
Country [16] 0 0
New Zealand
State/province [16] 0 0
Hamilton
Country [17] 0 0
New Zealand
State/province [17] 0 0
Wellington
Country [18] 0 0
Sweden
State/province [18] 0 0
Gothenburg
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Lanarkshire
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Manchester

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 long-term safety of once-daily application of Omiganan topical gel in subjects with severe papulopustular rosacea.
Trial website
https://clinicaltrials.gov/study/NCT02576847
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02576847