Efficacy and Tolerability of Topical Rossoseq™ Compared to Vehicle in Rosacea Subtype 1 (Erythematotelangiectatic)

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)

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.

Study Overview

• Status: Completed
• Conditions: Rosacea Subtype 1 (Erythematotelangiectatic)
• Intervention / Treatment: Device: Rossoseq™; Device: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bochum, Germany
    • Study site 5
  • Duelmen, Germany
    • Study Site 2
  • Münster, Germany
    • Study Site 1
  • Paderborn, Germany
    • Study Site 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rossoseq™; Gel, topically applied twice daily	Device: Rossoseq™
Placebo Comparator: Vehicle; Gel, topically applied twice	Device: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Change from baseline to Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total R-QOL	The total R-QOL is the average of all responses	Change from baseline to Week 4
Function construct of the R-QOL		Change from baseline to Week 4
Emotion construct of the R-QOL		Change from baseline to Week 4
Total RSGS score		Change from baseline to Week 4

Collaborators and Investigators

• Sponsor: PBB Entrepreneur Ltd.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: August 14, 2012
• First Submitted That Met QC Criteria: August 15, 2012
• First Posted (Estimate): August 16, 2012

Study Record Updates

• Last Update Posted (Estimate): January 7, 2013
• Last Update Submitted That Met QC Criteria: January 4, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Rosacea
• Other Study ID Numbers: CL-068-IV-01