Rosacea Subtype 1 (Erythematotelangiectatic)NCT01666509
Efficacy and Tolerability of Topical Rossoseq™ Compared to Vehicle in Rosacea Subtype 1 (Erythematotelangiectatic)
A study testing Rossoseq™ in people with Rosacea Subtype 1 (Erythematotelangiectatic), run by PBB Entrepreneur Ltd. at 4 sites in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Rosacea Subtype 1 (Erythematotelangiectatic)
- What is being tested?
- Rossoseq™
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 4 sitesGermany
- Study dates
- Jul 2012to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Study site 5
Bochum
Study site 2
Dülmen
Study Site 1
Münster
Study site 4
Paderborn
About this study
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.
Read the 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.
- Being tested
- Rossoseq™, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rossoseq™Device
PlaceboDevice
| Study group | Role | What they receive |
|---|---|---|
| Rossoseq™ | Experimental | Gel, topically applied twice daily Receives: Device: Rossoseq™ |
| Vehicle | Placebo comparator | Gel, topically applied twice Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change from baseline to Week 4
Secondary outcomes (4)
Total R-QOL
The total R-QOL is the average of all responses
Measured: Change from baseline to Week 4
Function construct of the R-QOL
Measured: Change from baseline to Week 4
Emotion construct of the R-QOL
Measured: Change from baseline to Week 4
Total RSGS score
Measured: Change from baseline to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rosacea Subtype 1 (Erythematotelangiectatic)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- PBB Entrepreneur Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666509
- Sponsor's protocol ID
- CL-068-IV-01
- Status last verified
- Jan 2013
- First submitted
- 14 Aug 2012
- Last updated
- 7 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01666509
- Acronym / sponsor ID
- CL-068-IV-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- PBB Entrepreneur Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 16 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rossoseq™ | Experimental | Device: Rossoseq™Gel, topically applied twice daily |
| Vehicle | Placebo comparator | Device: PlaceboGel, topically applied twice |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
- Pregnancy or lactation
- Women with the following menopausal symptoms within the last two years prior to screening: excessive sweating, flushing, mood changes
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rossoseq™ | Device | Rossoseq™ |
| Placebo | Device | Vehicle |
Primary outcome
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).
4 secondary outcomes
Total R-QOL
Time frame: Change from baseline to Week 4
Function construct of the R-QOL
Time frame: Change from baseline to Week 4
Emotion construct of the R-QOL
Time frame: Change from baseline to Week 4
Total RSGS score
Time frame: Change from baseline to Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rossoseq™ in people with Rosacea Subtype 1 (Erythematotelangiectatic), run by PBB Entrepreneur Ltd. at 4 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom construct of the R-QOL (time frame: Change from baseline to Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2013.