Erythematous (Type One) RosaceaPhase 2NCT01186068
Dose Response Study of Patients With Erythematous Rosacea
A Phase 2 study testing V-101 in people with Erythematous (Type One) Rosacea, run by Vicept Therapeutics, Inc. at 7 sites in United States.
Trial summary
The purpose of this study is to evaluate the dose-response relationship (effect) of four concentrations of V-101 Cream in patients with erythematous(redness) rosacea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Erythematous (Type One) Rosacea
- What is being tested?
- V-101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 175 participants
- Where
- 7 sitesUnited States
- Study dates
- Aug 2010to not given
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or females at least 18 years of age
- diagnosis of stable erythematous rosacea
- < 3 inflammatory lesions
- in good general health
- females must be non-pregnant and non-lactating
- must be willing to sign a consent form
Who cannot join
- have ocular, phymatous or other types of rosacea
- allergy to any ingredient in study drug
- participation in other investigational studies within 30 days of enrollment
- use of systemic steroids within 28 days of Baseline
- use of tetracycline antibiotics within 28 days of baseline
- use of products containing oxymetazoline within 14 days of baseline
Show all 11Show fewer
- use of topical steroids witin treatment area 14 days prior to baseline
- use of Rx or OTC products for treatment of acne or rosacea within 14 days of baseline
- use of any product for reducing redness within the treatment area witin 14 days prior to baseline
- use of monoamine oxidase (MAO) inhibitors
- use of niacin >/= 500mg/day
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
DermResearch, Inc.
Austin, Texas, 78759
DBA Michigan Center for Skin Care Research
Clinton Twp, Michigan, 48038
Dermatology Specialists Research
Louisville, Kentucky, 40202
Baumann Cosmetic & Research Institute
Miami Beach, Florida, 33140
Oregon Medical Research Center, PC
Portland, Oregon, 97223
Therapeutics Clinical Research
San Diego, California, 92123
About this study
Official title: A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study of the Dose-Response Profile of V-101 Cream in Subjects With Erythematous Rosacea
The purpose of this study is to evaluate the dose-response relationship (effect) of four concentrations of V-101 Cream in patients with erythematous(redness) rosacea.
Read the detailed description
Patients must have moderate to severe erythematous (facial redness) rosacea
- Male and female patients must be at least 18 years old and in good general health
- Female patients must not be pregnant or nursing
- Conditions
- Erythematous (Type One) Rosacea
- Being tested
- V-101, vehicle
- Keywords
- Rosacea, erythema
- Medical subject headings
- Rosacea, Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V-101Drug
Cream QD
vehicleOther
Cream QD
| Study group | Role | What they receive |
|---|---|---|
| V-101 Cream 0.01% Concentration | Experimental | Low dose Receives: Drug: V-101 |
| V-101 Cream 0.06% Concentration | Experimental | Mid-dose Receives: Drug: V-101 |
| V-101 Cream 0.1% Concentration | Experimental | Mid-dose Receives: Drug: V-101 |
| V-101 Cream 0.15% Concentration | Experimental | High dose Receives: Drug: V-101 |
| Vehicle | Placebo comparator | Cream without an active ingredient Receives: Other: vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician's Erythema Assessment
Physician visual evaluation
Measured: Day 28 visit
Secondary outcomes (1)
Subject's Self Assessment
Patient assesses their condition
Measured: 28 Day Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2010 (estimated)
- Study startAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erythematous (Type One) RosaceaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vicept Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Accenture
- Investigators
- Stacy R Smith, MD, Principal investigator, Therapeutics Clinical ResearchMichael T Jarratt, MD, Principal investigator, Derm Research, PLLCLeslie S Baumann, MD, Principal investigator, Baumann Cosmetic & Research InstituteJoseph F Fowler, MD, Principal investigator, Dermatology Specialists ResearchRobert T Matheson, MD, Principal investigator, Oregon Medical Research Center, PCDaniel M Stewart, DO, Principal investigator, DBA Michigan Center for Skin Care ResearchEduardo Tschen, MD, Principal investigator, Academic Dermatology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01186068
- Sponsor's protocol ID
- V-101-ROSE-202
- Status last verified
- Aug 2010
- First submitted
- 17 Aug 2010
- Last updated
- 24 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study of the Dose-Response Profile of V-101 Cream in Subjects With Erythematous Rosacea
- ClinicalTrials.gov ID
- NCT01186068
- Acronym / sponsor ID
- V-101-ROSE-202
- Conditions
- Erythematous (Type One) Rosacea
- Keywords
- Rosacea, erythema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Vicept Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Accenture
- Study start
- Aug 2010
- First posted
- 20 Aug 2010 (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.
The purpose of this study is to evaluate the dose-response relationship (effect) of four concentrations of V-101 Cream in patients with erythematous(redness) rosacea.
Detailed description
Patients must have moderate to severe erythematous (facial redness) rosacea
- Male and female patients must be at least 18 years old and in good general health
- Female patients must not be pregnant or nursing
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| V-101 Cream 0.01% Concentration | Experimental | Drug: V-101Low dose |
| V-101 Cream 0.06% Concentration | Experimental | Drug: V-101Mid-dose |
| V-101 Cream 0.1% Concentration | Experimental | Drug: V-101Mid-dose |
| V-101 Cream 0.15% Concentration | Experimental | Drug: V-101High dose |
| Vehicle | Placebo comparator | Other: vehicleCream without an active ingredient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- male or females at least 18 years of age
- diagnosis of stable erythematous rosacea
- < 3 inflammatory lesions
- in good general health
- females must be non-pregnant and non-lactating
Key exclusion criteria (11 listed)
- have ocular, phymatous or other types of rosacea
- allergy to any ingredient in study drug
- participation in other investigational studies within 30 days of enrollment
- use of systemic steroids within 28 days of Baseline
- use of tetracycline antibiotics within 28 days of baseline
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 |
|---|---|---|
| V-101Cream QD | Drug | V-101 Cream 0.01% Concentration, V-101 Cream 0.06% Concentration, V-101 Cream 0.1% Concentration, V-101 Cream 0.15% Concentration |
| vehicleCream QD | Other | Vehicle |
Primary outcome
Clinician's Erythema Assessment
Time frame: Day 28 visit
Physician visual evaluation
1 secondary outcome
Subject's Self Assessment
Time frame: 28 Day Visit
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 24 Nov 2010.
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.
Stacy R Smith, MD principal investigator
Therapeutics Clinical Research
Michael T Jarratt, MD principal investigator
Derm Research, PLLC
Leslie S Baumann, MD principal investigator
Baumann Cosmetic & Research Institute
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing V-101 in people with Erythematous (Type One) Rosacea, run by Vicept Therapeutics, Inc. at 7 sites 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?
The sponsor lists 6 inclusion and 11 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 24 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Clinician's Erythema Assessment (time frame: Day 28 visit). 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 24 Nov 2010.