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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01666509
Recruitment Status : Completed
First Posted : August 16, 2012
Last Update Posted : January 7, 2013
Information provided by (Responsible Party):
PBB Entrepreneur Ltd.

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Rosacea
MedlinePlus related topics: Rosacea

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

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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01666509

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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.
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Responsible Party: PBB Entrepreneur Ltd. Identifier: NCT01666509    
Other Study ID Numbers: CL-068-IV-01
First Posted: August 16, 2012    Key Record Dates
Last Update Posted: January 7, 2013
Last Verified: January 2013
Additional relevant MeSH terms:
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Skin Diseases