Acne VulgarisPhase 3NCT00664248
A Clinical Study Evaluating the Safety and Efficacy of IDP-110 in Patients With Acne Vulgaris
A Phase 3 study testing IDP-110, Clindamycin and Benzoyl peroxide in people with Acne Vulgaris, run by Dow Pharmaceutical Sciences at 35 sites in 3 countries.
Trial summary
The purpose of this study is to assess the effectiveness of IDP-110 in treating patients with acne vulgaris. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- IDP-110, Clindamycin and Benzoyl peroxide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,414 participants
- Where
- 35 sitesin 3 countries
- Study dates
- Oct 2006to Aug 2007
- Phase
- Phase 3
- 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 to 70 years
- 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 other than acne 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
35 sites in 3 countries.
35 sites in 3 countries
United States33 sites
Academic Dermatology
Albuquerque, New Mexico, 87106
Total Skin and Beauty Dermatology Center
Birmingham, Alabama, 35205
University of Alabama, Birmingham
Birmingham, Alabama, 35233
Office of Scott Glazer, MD
Buffalo Grove, Illinois, 60089
Triangle Medical Research Associates
Cary, North Carolina, 27511
Cherry Creek Dermatology Research Inc.
Denver, Colorado, 80246
Henry Ford Medical Center
Detroit, Michigan, 48202
Rivergate Dermatology
Goodlettsville, Tennessee, 37072
Unifour Medical Research Associates
Hickory, North Carolina, 28601
The Center for Skin Research
Houston, Texas, 77056
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, 35801
Dermatology Associates
Knoxville, Tennessee, 37922
Dermatology Research of Arkansas
Little Rock, Arkansas, 72205
Longmont Medical Research Network
Longmont, Colorado, 80501
International Dermatology Research, Inc.
Miami, Florida, 33144
FXM Research
Miami, Florida, 33175
Advanced Healthcare
Milwaukee, Wisconsin, 53209
Dermatology Research Associates
Nashville, Tennessee, 37203
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Northwest Cutaneous Research Specialists
Portland, Oregon, 97210
Oregon Medical Center, PC
Portland, Oregon, 97223
Wake Research Associates, LLC
Raleigh, North Carolina, 27612
The Nevada Center for Dermatology
Reno, Nevada, 89511
Dermatology Resarch Center
Salt Lake City, Utah, 84124
Progressive Clinical Research
San Antonio, Texas, 78229
Affiliated Research Institute - Dermatology
San Diego, California, 92108
Therapeutics Clinical Research
San Diego, California, 92123
University of California, San Diego, Pediatric and Adolescent Dermatology
San Diego, California, 92123
Solano Clinical Research
Vallejo, California, 94589
Dermatology Specialists, Inc.
Vista, California, 92083
Advanced Clinical Research - Jordan Valley
West Jordan, Utah, 84088
Clinical Research Specialists
West Santa Monica, California, 90404-2115
New Haven Medical Research
Wilmington, North Carolina, 28401
Belize1 site
Dermatology and Skin Surgery Centre
Belize City
About this study
The purpose of this study is to assess the effectiveness of IDP-110 in treating patients with acne vulgaris.
- Conditions
- Acne Vulgaris
- Being tested
- IDP-110, Clindamycin, Benzoyl peroxide, Vehicle
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDP-110Drug
Topical application for 12 weeks
ClindamycinDrug
Topical application for 12 weeks
Benzoyl peroxideDrug
Topical application for 12 weeks
VehicleDrug
Topical application for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: IDP-110 |
| 2 | Active comparator | Not described Receives: Drug: Clindamycin |
| 3 | Active comparator | Not described Receives: Drug: Benzoyl peroxide |
| 4 | 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 number of lesions
Measured: 12 weeks
Secondary outcomes (1)
Change from baseline in global severity
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 posted22 Apr 2008 (estimated)
- Study startOct 2006
- Primary completionAug 2007
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,414 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow Pharmaceutical Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00664248
- Sponsor's protocol ID
- DPSI-06-22-2006-012
- Status last verified
- Apr 2008
- First submitted
- 15 Apr 2008
- Last updated
- 22 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Evaluating the Safety and Efficacy of IDP-110 in Patients With Acne Vulgaris
- ClinicalTrials.gov ID
- NCT00664248
- Acronym / sponsor ID
- DPSI-06-22-2006-012
- Conditions
- Acne Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,414 participants (actual)
- Lead sponsor
- Dow Pharmaceutical SciencesIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Aug 2007 (actual)
- First posted
- 22 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 effectiveness of IDP-110 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
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: IDP-110 |
| 2 | Active comparator | Drug: Clindamycin |
| 3 | Active comparator | Drug: Benzoyl peroxide |
| 4 | Placebo comparator | Drug: Vehicle |
Who may qualify
- Ages
- 12 to 70 years
- 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 other than acne 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 |
|---|---|---|
| IDP-110Topical application for 12 weeks | Drug | 1 |
| ClindamycinTopical application for 12 weeks | Drug | 2 |
| Benzoyl peroxideTopical application for 12 weeks | Drug | 3 |
| VehicleTopical application for 12 weeks | Drug | 4 |
Primary outcome
Change from baseline in number of lesions
Time frame: 12 weeks
1 secondary outcome
Change from baseline in global severity
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 22 Apr 2008.
Related trials for Acne Vulgaris
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
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.
35 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IDP-110, Clindamycin and Benzoyl peroxide in people with Acne Vulgaris, run by Dow Pharmaceutical Sciences at 35 sites in 3 countries.
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 22 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Belize, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 number of lesions (time frame: 12 weeks). 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 22 Apr 2008.