Acne VulgarisPhase 2NCT01194375
A Dose-Ranging 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 20 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of IDP-107 versus placebo 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
- 180 participants
- Where
- 20 sitesin 2 countries
- Study dates
- Sep 2010to Dec 2011
- 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 acne vulgaris on the face and neck/trunk
- Presence of inflammatory and non-inflammatory lesions on the face
Who cannot join
- Presence of any skin condition on the face that could interfere with clinical evaluations
- Use of any systemic antibiotics or corticosteroids within 4 weeks prior to the Baseline visit
- Use of any systemic retinoids, such as isotretinoin, within 3 months prior to the Baseline visit
- Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
United States17 sites
DermResearch, Inc.
Austin, Texas, 78759
Comprehensive Clinical Research
Berlin, New Jersey, 08009
Horizons Clinical Research Center, LLC
Denver, Colorado, 80220
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
ActivMed Practices and Research, Inc.
Haverhill, Massachusetts, 01830
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46256
North Florida Dermatology Associates, PA
Jacksonville, Florida, 32204
FXM Research Corp.
Miami, Florida, 33175
Dermatology Specialists, Inc.
Oceanside, California, 92056
Ameriderm Research
Ormond Beach, Florida, 32174
Pedia Research LLC
Owensboro, Kentucky, 42301
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168
Oregon Dermatology and Research Center
Portland, Oregon, 97210
Dermatology Research Center, Inc.
Salt Lake City, Utah, 84124
Premier Clinical Research
Spokane, Washington, 99204
South Valley Dermatology
West Jordan, Utah, 84088
Canada3 sites
Ultranova Skincare
Barrie, Ontario, L4M 6L2
The Centre for Dermatology and Cosmetic Surgery
Richmond Hill, Ontario, L4B 1A5
K. Papp Clinical Research
Waterloo, Ontario, N2J 1C4
About this study
The purpose of this study is to evaluate the safety and efficacy of IDP-107 versus placebo in treating patients with acne vulgaris.
- Conditions
- Acne Vulgaris
- Being tested
- Low Strength IDP-107, High Strength IDP-107, Placebo
- 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 16 weeks
High Strength IDP-107Drug
Once a day for 16 weeks
PlaceboDrug
Once a day for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Low Strength IDP-107 | Experimental | Not described Receives: Drug: Low Strength IDP-107 |
| High Strength IDP-107 | Experimental | Not described Receives: Drug: High Strength IDP-107 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
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: Baseline and 22 weeks
Percent of patients who achieve success for the acne global severity score
Measured: Baseline and 22 weeks
Secondary outcomes (1)
Change from baseline in the number of non-inflammatory lesions
Measured: Baseline and 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2011
- Study completionDec 2011
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
- 180 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
- NCT01194375
- Sponsor's protocol ID
- DPSI-IDP-107-P2-02
- Status last verified
- Jun 2012
- First submitted
- 1 Sep 2010
- Last updated
- 2 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne Vulgaris
- ClinicalTrials.gov ID
- NCT01194375
- Acronym / sponsor ID
- DPSI-IDP-107-P2-02
- Conditions
- Acne Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Dow Pharmaceutical SciencesIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 3 Sep 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 safety and efficacy of IDP-107 versus placebo 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 |
|---|---|---|
| Low Strength IDP-107 | Experimental | Drug: Low Strength IDP-107 |
| High Strength IDP-107 | Experimental | Drug: High Strength IDP-107 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Presence of acne vulgaris on the face and neck/trunk
- Presence of inflammatory and non-inflammatory lesions on the face
Key exclusion criteria (4 listed)
- Presence of any skin condition on the face that could interfere with clinical evaluations
- Use of any systemic antibiotics or corticosteroids within 4 weeks prior to the Baseline visit
- Use of any systemic retinoids, such as isotretinoin, within 3 months prior to the Baseline visit
- Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period
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 16 weeks | Drug | Low Strength IDP-107 |
| High Strength IDP-107Once a day for 16 weeks | Drug | High Strength IDP-107 |
| PlaceboOnce a day for 16 weeks | Drug | Placebo |
Primary outcome
Change from baseline in the number of inflammatory lesions
Time frame: Baseline and 22 weeks
Percent of patients who achieve success for the acne global severity score
Time frame: Baseline and 22 weeks
1 secondary outcome
Change from baseline in the number of non-inflammatory lesions
Time frame: Baseline and 22 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 2 Jul 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.
20 sites in 2 countries: 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 20 sites in 2 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 2 inclusion and 4 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 2 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, 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 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: Baseline and 22 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 2 Jul 2012.