RosaceaPhase 1NCT00279890
Topical Agent for Treatment of Red Skin
A Phase 1 study testing Topical SR-01 in people with Rosacea and Bilaterally Symmetric Red Skin on Cheeks, run by Mayo Clinic at 1 site in United States.
Trial summary
SR-01 may reduce facial redness. it is a topically applied product. The agent will be applied to local skin areas of subjects with red facial skin to assess affect, and then applied to the whole face to assess efficacy and safety Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rosacea, Bilaterally Symmetric Red Skin on Cheeks
- What is being tested?
- Topical SR-01
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Jan 2007
- Phase
- Phase 1
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Bilaterally symmetric red skin on cheeks Caucasian Age 18-60 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proof of Concept Trial:SR-01 for the Treatment of Rosacea
SR-01 may reduce facial redness. it is a topically applied product. The agent will be applied to local skin areas of subjects with red facial skin to assess affect, and then applied to the whole face to assess efficacy and safety
- Conditions
- Rosacea, Bilaterally Symmetric Red Skin on Cheeks
- Being tested
- Topical SR-01
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical SR-01Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of redness
Secondary outcomes (2)
Safety and tolerability
Cosmetic acceptability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2006 (estimated)
- Study startJul 2005
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RosaceaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Mark V. Dahl, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00279890
- Sponsor's protocol ID
- 44-05
- Other IDs
- MCS 385
- Status last verified
- May 2011
- First submitted
- 18 Jan 2006
- Last updated
- 23 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept Trial:SR-01 for the Treatment of Rosacea
- ClinicalTrials.gov ID
- NCT00279890
- Acronym / sponsor ID
- 44-05
- Conditions
- Rosacea, Bilaterally Symmetric Red Skin on Cheeks
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 20 Jan 2006 (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.
SR-01 may reduce facial redness. it is a topically applied product. The agent will be applied to local skin areas of subjects with red facial skin to assess affect, and then applied to the whole face to assess efficacy and safety
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| Topical SR-01 | Drug | – |
Primary outcome
Reduction of redness
2 secondary outcomes
Safety and tolerability
Cosmetic acceptability
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 23 May 2011.
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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.
Mark V. Dahl, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Topical SR-01 in people with Rosacea and Bilaterally Symmetric Red Skin on Cheeks, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 23 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Reduction of redness. 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 23 May 2011.