Efficacy and Tolerability of Topical Rossoseq™ Compared to Vehicle in Rosacea Subtype 1 (Erythematotelangiectatic)
Primary Purpose
Rosacea Subtype 1 (Erythematotelangiectatic)
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Rossoseq™
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rosacea Subtype 1 (Erythematotelangiectatic)
Eligibility Criteria
Inclusion Criteria:
- Signed and dated informed consent prior to any study-mandated procedure
- Clinically diagnosed rosacea defined by a score of ≥6 and ≤15 out of a maximum score of 30 for the primary and secondary features of the RSGS
- Female subjects of childbearing potential must be using appropriate birth control
Main exclusion Criteria:
- Pregnancy or lactation
- Women with the following menopausal symptoms within the last two years prior to screening: excessive sweating, flushing, mood changes
- Ocular manifestations of rosacea
- Peripheral location(s) of rosacea
- Phymatous changes
- Severe facial skin dryness or xerosis
- Keratoconjunctivitis sicca
- Flushing due to conditions other than rosacea
- Any other abnormal facial skin conditions, e.g., eczema, perioral dermatitis, broken and bleeding skin on area of application
- Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma
Sites / Locations
- Study site 5
- Study site 2
- Study Site 1
- Study site 4
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Rossoseq™
Vehicle
Arm Description
Gel, topically applied twice daily
Gel, topically applied twice
Outcomes
Primary Outcome Measures
Symptom construct of the R-QOL
The symptom construct contains 7 symptom related items scored by the subject as ''never'', ''rarely'', ''sometimes'', ''often'' or ''all the time''. The responses are recorded on a 1 (never)-to-5 (all the time) scale. A subject's score is the average of his or her responses to the items in the construct (1-5).
Secondary Outcome Measures
Total R-QOL
The total R-QOL is the average of all responses
Function construct of the R-QOL
Emotion construct of the R-QOL
Total RSGS score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01666509
Brief Title
Efficacy and Tolerability of Topical Rossoseq™ Compared to Vehicle in Rosacea Subtype 1 (Erythematotelangiectatic)
Official Title
A Post Marketing Clinical Follow-up, Randomised, Double-blind Study Comparing the Efficacy and Tolerability of Topical Rossoseq™ With Vehicle in Rosacea Subtype 1 (Erythematotelangiectatic)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PBB Entrepreneur Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Rossoseq™ is registered for the treatment of inflammatory skin conditions. Rosacea is one such inflammatory skin disorder that has not been studied yet for the use of Rossoseq™. Whilst rosacea is showing features of an inflammatory skin disorder [1], particularly stage 1 is poorly understood and treatment options are limited and therefore this study - within the target indication - will contribute to the learning about rosacea.
Detailed Description
Male or female subjects ≥18 and < 85 years with a clinically diagnosed rosacea subtype 1 (erythematotelangiectatic) defined by a score of 6-15 for the primary and secondary features of the rosacea standard grading system (RSGS; Wilkin et al, 2004) will be enrolled.
The study will consist of a Screening visit, Baseline visit (Week 0), a telephone call at Week 1, visits at Week 2 and 4, and a follow-up telephone call at Week 5. Eligible subjects may or may not be using medication for their rosacea at the time of screening. Subjects with concomitant use of rosacea treatments will be taken off their current medication and will return for a Baseline Visit at the end of the wash-out period.
Eligible subjects will be stratified by gender at a ratio of 4:1 (Female: Male). Within the strata, subjects will be randomised at Baseline in a 2:1 ratio in favour of Rossoseq™ to receive either Rossoseq™ or vehicle.
Efficacy will be evaluated using subject rating of the rosacea specific quality of life instrument (R-QOL; Nicholson et al, 2007) during office visits and applied over the phone during the week 1 and follow-up telephone call at Week 5. An investigator rating will be performed using a "0=absent" to "3=severe" grading of the RSGS primary features flushing, nontransient erythema, papules and pustules, telangiectasia and the secondary features burning or stinging, plaques, dry appearance, edema, ocular manifestations and phymatous changes during the office visits. Ocular manifestations and phymatous changes need to be absent to be eligible for the study.
Photographs to document treatment effects will be taken at screening, baseline, week 2 and week 4.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea Subtype 1 (Erythematotelangiectatic)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rossoseq™
Arm Type
Experimental
Arm Description
Gel, topically applied twice daily
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Gel, topically applied twice
Intervention Type
Device
Intervention Name(s)
Rossoseq™
Intervention Type
Device
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Symptom construct of the R-QOL
Description
The symptom construct contains 7 symptom related items scored by the subject as ''never'', ''rarely'', ''sometimes'', ''often'' or ''all the time''. The responses are recorded on a 1 (never)-to-5 (all the time) scale. A subject's score is the average of his or her responses to the items in the construct (1-5).
Time Frame
Change from baseline to Week 4
Secondary Outcome Measure Information:
Title
Total R-QOL
Description
The total R-QOL is the average of all responses
Time Frame
Change from baseline to Week 4
Title
Function construct of the R-QOL
Time Frame
Change from baseline to Week 4
Title
Emotion construct of the R-QOL
Time Frame
Change from baseline to Week 4
Title
Total RSGS score
Time Frame
Change from baseline to Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed and dated informed consent prior to any study-mandated procedure
Clinically diagnosed rosacea defined by a score of ≥6 and ≤15 out of a maximum score of 30 for the primary and secondary features of the RSGS
Female subjects of childbearing potential must be using appropriate birth control
Main exclusion Criteria:
Pregnancy or lactation
Women with the following menopausal symptoms within the last two years prior to screening: excessive sweating, flushing, mood changes
Ocular manifestations of rosacea
Peripheral location(s) of rosacea
Phymatous changes
Severe facial skin dryness or xerosis
Keratoconjunctivitis sicca
Flushing due to conditions other than rosacea
Any other abnormal facial skin conditions, e.g., eczema, perioral dermatitis, broken and bleeding skin on area of application
Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma
Facility Information:
Facility Name
Study site 5
City
Bochum
Country
Germany
Facility Name
Study site 2
City
Duelmen
Country
Germany
Facility Name
Study Site 1
City
Münster
Country
Germany
Facility Name
Study site 4
City
Paderborn
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Tolerability of Topical Rossoseq™ Compared to Vehicle in Rosacea Subtype 1 (Erythematotelangiectatic)
We'll reach out to this number within 24 hrs