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

NCT01666509 | Completed

• 1 other identifier: CL-068-IV-01
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 4

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.

Conditions

Rosacea Subtype 1 (Erythematotelangiectatic)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Total R-QOL

  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

Study Arms (2)

Rossoseq™

EXPERIMENTAL

Gel, topically applied twice daily

Device: Rossoseq™

Vehicle

PLACEBO COMPARATOR

Gel, topically applied twice

Device: Placebo

Interventions

Rossoseq™ DEVICE

Rossoseq™

Placebo DEVICE

Vehicle

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PBB Entrepreneur Ltd.: lead

Study Sites (4)

Study site 5

Bochum, Germany

Location

Study site 2

Dülmen, Germany

Location

Study Site 1

Münster, Germany

Location

Study site 4

Paderborn, Germany

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2012
• First Posted: August 16, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 7, 2013

Record last verified: 2013-01

Locations

DE (4)