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

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01666509
• Other study ID #: CL-068-IV-01
• Status: Completed
• Phase: N/A
• First received: August 14, 2012
• Last updated: January 4, 2013
• Start date: July 2012
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: PBB Entrepreneur Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany:Ethikkommission der ÄK Westfalen
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rosacea
• Rosacea Subtype 1 (Erythematotelangiectatic)

Intervention

Device:
• Rossoseq™

• Placebo

Locations

Country	Name	City	State
Germany	Study site 5	Bochum
Germany	Study site 2	Duelmen
Germany	Study Site 1	Münster
Germany	Study site 4	Paderborn

Sponsors (1)

Lead Sponsor	Collaborator
PBB Entrepreneur Ltd.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Total R-QOL	The total R-QOL is the average of all responses	Change from baseline to Week 4	No
Secondary	Function construct of the R-QOL		Change from baseline to Week 4	No
Secondary	Emotion construct of the R-QOL		Change from baseline to Week 4	No
Secondary	Total RSGS score		Change from baseline to Week 4	No