Acne VulgarisPhase 2NCT00666900
A Clinical Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne Vulgaris
A Phase 2 study testing Low Strength IDP-107 and High Strength IDP-107 in people with Acne Vulgaris, run by Dow Pharmaceutical Sciences at 25 sites in United States.
Trial summary
The purpose of this study is to assess the safety and effectiveness of IDP-107 in treating patients with acne vulgaris. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Low Strength IDP-107 and High Strength IDP-107
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 366 participants
- Where
- 25 sitesUnited States
- Study dates
- Jan 2008to Sep 2009
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Presence of inflammatory and non-inflammatory lesions
Who cannot join
- Dermatological conditions of the face that could interfere with clinical evaluations
- Female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
Arlington Research Center, Inc.
Arlington, Texas, 76011
DermResearch, Inc.
Austin, Texas, 78759
J & S Studies, Inc.
Bryan, Texas, 77802
University of North Carolina Hospitals and School of Medicine
Chapel Hill, North Carolina, 27599
Michigan Center for Skin Care Research
Clinton Township, Michigan, 48038
Cherry Creek Research, Inc.
Denver, Colorado, 80209
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
The Center for Skin Research
Houston, Texas, 77056
Dermatology Research of Arkansas, PLLC
Little Rock, Arkansas, 72205
Madison Skin & Research, Inc.
Madison, Wisconsin, 53719
FXM Research Corp.
Miami, Florida, 33175
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Skin Specialist, PC
Omaha, Nebraska, 68144
Oregon Dermatology and Research Center
Portland, Oregon, 97210
Dermatology Associates of Rochester
Rochester, New York, 14623
RADY Children's Hospital - San Diego
San Diego, California, 92123
Clinical Science Institute
Santa Monica, California, 90404
Premier Clinical Research
Spokane, Washington, 99204
DermResearchCenter of New York, Inc.
Stony Brook, New York, 11790
Solano Clinical Research
Vallejo, California, 94589
South Valley Dermatology
West Jordan, Utah, 84088
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Dose-Ranging Study to Evaluate IDP-107 Versus Placebo in the Treatment of Severe Acne Vulgaris With Nodules
The purpose of this study is to assess the safety and effectiveness of IDP-107 in treating patients with acne vulgaris.
- Conditions
- Acne Vulgaris
- Being tested
- Low Strength IDP-107, High Strength IDP-107, Placebo Comparator
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Strength IDP-107Drug
Once a day for 12 weeks
High Strength IDP-107Drug
Once a day for 12 weeks
Placebo ComparatorDrug
Once a day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Low Strength IDP-107 |
| 2 | Experimental | Not described Receives: Drug: High Strength IDP-107 |
| 3 | Placebo comparator | Not described Receives: Drug: Placebo Comparator |
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 the number of non-inflammatory lesions
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 startJan 2008
- Primary completionMar 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies 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
- 366 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
- NCT00666900
- Sponsor's protocol ID
- DPSI-IDP-107-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, Multicenter, Randomized, Double-Blind, Dose-Ranging Study to Evaluate IDP-107 Versus Placebo in the Treatment of Severe Acne Vulgaris With Nodules
- ClinicalTrials.gov ID
- NCT00666900
- Acronym / sponsor ID
- DPSI-IDP-107-P2-01
- Conditions
- Acne Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 366 participants (actual)
- Lead sponsor
- Dow Pharmaceutical SciencesIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Sep 2009 (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-107 in treating patients with acne vulgaris.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Low Strength IDP-107 |
| 2 | Experimental | Drug: High Strength IDP-107 |
| 3 | Placebo comparator | Drug: Placebo Comparator |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Presence of inflammatory and non-inflammatory lesions
Key exclusion criteria (2 listed)
- Dermatological conditions of the face that could interfere with clinical evaluations
- 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 |
|---|---|---|
| Low Strength IDP-107Once a day for 12 weeks | Drug | 1 |
| High Strength IDP-107Once a day for 12 weeks | Drug | 2 |
| Placebo ComparatorOnce a day 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 the number of non-inflammatory lesions
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.
25 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 Low Strength IDP-107 and High Strength IDP-107 in people with Acne Vulgaris, run by Dow Pharmaceutical Sciences at 25 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 1 inclusion and 2 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 25 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.