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

• ClinicalTrials.gov Identifier: NCT01666509
• Recruitment Status: Completed
• First Posted: August 16, 2012
• Last Update Posted: January 7, 2013
• Sponsor: PBB Entrepreneur Ltd.
• Information provided by (Responsible Party): PBB Entrepreneur Ltd.

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.

Condition or disease	Intervention/treatment	Phase
Rosacea Subtype 1 (Erythematotelangiectatic)	Device: Rossoseq™; Device: Placebo	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 61 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: July 2012
• Actual Primary Completion Date: December 2012
• Actual Study Completion Date: December 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Symptom construct of the R-QOL [ Time Frame: Change from baseline to Week 4 ]
   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 :

1. Total R-QOL [ Time Frame: Change from baseline to Week 4 ]
   The total R-QOL is the average of all responses
2. Function construct of the R-QOL [ Time Frame: Change from baseline to Week 4 ]
3. Emotion construct of the R-QOL [ Time Frame: Change from baseline to Week 4 ]
4. Total RSGS score [ Time Frame: Change from baseline to Week 4 ]

Eligibility Criteria

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

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

Contacts and Locations

Locations

Germany

Study site 5

Bochum, Germany

Study site 2

Duelmen, Germany

Study Site 1

Münster, Germany

Study site 4

Paderborn, Germany

Sponsors and Collaborators

PBB Entrepreneur Ltd.

More Information

• Responsible Party: PBB Entrepreneur Ltd.
• ClinicalTrials.gov Identifier: NCT01666509
• Other Study ID Numbers: CL-068-IV-01
• First Posted: August 16, 2012
• Last Update Posted: January 7, 2013
• Last Verified: January 2013

Additional relevant MeSH terms:

Rosacea; Skin Diseases