Rosacea Subtype 1 (Erythematotelangiectatic) Clinical Trial
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)
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment