RosaceaPhase 2NCT00667173
A Clinical Study Evaluating the Safety and Efficacy of IDP-115 in Patients With Rosacea
A Phase 2 study testing IDP-115 in people with Rosacea, run by Dow Pharmaceutical Sciences at 10 sites in United States.
Trial summary
The purpose of this study is to assess the safety and effectiveness of IDP-115 in treating patients with rosacea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rosacea
- What is being tested?
- IDP-115
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 10 sitesUnited States
- Study dates
- Nov 2007to Jul 2008
- 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
- Presence of facial rosacea
- Presence of inflammatory lesions
Who cannot join
- Dermatological conditions of the face that could interfere with clinical evaluations
- Known history of photosensitivity disorders (such as lupus erythematosus or polymorphous light eruption)
- Female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
DermResearch, Inc.
Austin, Texas, 78759
University Dermatology Consultants, Inc.
Cincinnati, Ohio, 45219
Cherry Creek Dermatology Research Inc.
Denver, Colorado, 80246
Henry Ford Medical Center
Detroit, Michigan, 48202
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, 35801
FXM Research Corp.
Miami, Florida, 33175
MedaPhase Inc.
Newnan, Georgia, 30263
Therapeutics Clinical Research
San Diego, California, 92123
Solano Clinical Research
Vallejo, California, 94589
About this study
Official title: A Phase 2, Multi-Center, Evaluator-Blind, Randomized, Vehicle-Controlled Clinical Study to Assess the Safety and Efficacy of IDP-115 in the Treatment of Rosacea
The purpose of this study is to assess the safety and effectiveness of IDP-115 in treating patients with rosacea.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDP-115Drug
Topical application for 12 weeks
VehicleDrug
Topical application for 12 weeks
VehicleDrug
Topical application for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: IDP-115 |
| 2 | Placebo comparator | Not described Receives: Drug: Vehicle |
| 3 | Placebo comparator | Not described Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the number of inflammatory lesions
Measured: 12 weeks
Improvement from baseline in global severity
Measured: 12 weeks
Secondary outcomes (1)
Change from baseline in erythema
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2008 (estimated)
- Study startNov 2007
- Primary completionJul 2008
- Study completionJul 2008
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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow Pharmaceutical Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00667173
- Sponsor's protocol ID
- DPSI-IDP-115-P2-01
- Status last verified
- Feb 2012
- First submitted
- 23 Apr 2008
- Last updated
- 20 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multi-Center, Evaluator-Blind, Randomized, Vehicle-Controlled Clinical Study to Assess the Safety and Efficacy of IDP-115 in the Treatment of Rosacea
- ClinicalTrials.gov ID
- NCT00667173
- Acronym / sponsor ID
- DPSI-IDP-115-P2-01
- Conditions
- Rosacea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Dow Pharmaceutical SciencesIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 25 Apr 2008 (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 assess the safety and effectiveness of IDP-115 in treating patients with rosacea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: IDP-115 |
| 2 | Placebo comparator | Drug: Vehicle |
| 3 | Placebo comparator | Drug: Vehicle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Presence of facial rosacea
- Presence of inflammatory lesions
Key exclusion criteria (3 listed)
- Dermatological conditions of the face that could interfere with clinical evaluations
- Known history of photosensitivity disorders (such as lupus erythematosus or polymorphous light eruption)
- Female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study
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 |
|---|---|---|
| IDP-115Topical application for 12 weeks | Drug | 1 |
| VehicleTopical application for 12 weeks | Drug | 2 |
| VehicleTopical application for 12 weeks | Drug | 3 |
Primary outcome
Change from baseline in the number of inflammatory lesions
Time frame: 12 weeks
Improvement from baseline in global severity
Time frame: 12 weeks
1 secondary outcome
Change from baseline in erythema
Time frame: 12 weeks
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 20 Feb 2012.
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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.
10 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 IDP-115 in people with Rosacea, run by Dow Pharmaceutical Sciences at 10 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 2 inclusion and 3 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 20 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
Change from baseline in the number of inflammatory lesions (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 20 Feb 2012.