RosaceaPhase 2NCT01828177
An Evaluation of PDI-320 in Comparison to Its Monads in Adults With Rosacea
A Phase 2 study testing PDI-320, PDI-320 Monad #1 and PDI-320 Monad #2 in people with Rosacea, run by PreCision Dermatology, Inc. at 2 sites in United States.
Trial summary
This 4-arm Phase 2 vehicle-controlled study is designed to assess the safety and efficacy of PDI-320, and the individual components, in adult subjects 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?
- PDI-320, PDI-320 Monad #1 and PDI-320 Monad #2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2013to Jun 2014
- 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
- Subject has moderate to severe papulopustular rosacea and at least mild erythema and mild telangiectasia.
- Subject is willing and able to apply the test article(s) as directed, comply with study instructions and commit to all follow-up visits for the duration of the study.
- If subject is a woman of childbearing potential, she must have a negative urine pregnancy test and agree to use an effective form of birth control for the duration of the study.
Who cannot join
- Subject is pregnant, lactating or is planning to become pregnant during the study.
- Subject has any other active dermatological condition on the face that may interfere with the conduct of the study.
- Subject has used systemic immunosuppressants within 30 days prior to study start.
- Subject has used systemic retinoids within 6 months prior to study start.
- Subject has used any topical rosacea therapy within 14 days prior to study start.
- Subject has had laser or light therapy on the face within 3 months of study start.
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- Subject is currently enrolled in an investigational drug or device study.
- Subject has used an investigational drug or investigational device treatment within 30 days prior to first application of the test article.
- Subject has used vasodilators or adrenergic blocking agents within 6 weeks of study start (except subjects on stable dose for greater than 3 months).
- Subject has active ocular rosacea and/or blepharitis/meibomianitis requiring treatment by an ophthalmologist.
- Subject has previously failed to have improvement of rosacea with appropriate use of systemic tetracycline family of antibiotics or use of the components of PDI-320.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Academic Dermatology Associates
Albuquerque, New Mexico
Therapeutics Clinical Research
San Diego, California
About this study
Official title: A Multicenter Randomized Evaluator-Blinded Vehicle-Controlled Parallel Group Evaluation of Twice Daily PDI-320 in Comparison to Its Monads in Adults With Rosacea
This 4-arm Phase 2 vehicle-controlled study is designed to assess the safety and efficacy of PDI-320, and the individual components, in adult subjects with rosacea.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDI-320Drug
PDI-320 Monad #1Drug
PDI-320 Monad #2Drug
VehicleDrug
| Study group | Role | What they receive |
|---|---|---|
| PDI-320 | Experimental | Foam, twice daily for up to 12 weeks Receives: Drug: PDI-320 |
| PDI-320 Monad #1 | Experimental | Foam, twice daily for up to 12 weeks Receives: Drug: PDI-320 Monad #1 |
| PDI-320 Monad #2 | Experimental | Foam, twice daily for up to 12 weeks Receives: Drug: PDI-320 Monad #2 |
| Vehicle | Placebo comparator | Foam, twice daily for up to 12 weeks Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment "Success Rate" based on change in Investigator's Global Assessment (IGA)
IGA Score Success Rate is defined as the percentage of subjects who achieve "Clear" (score = 0) or "Almost Clear" (score = 1) and have at least a 2-grade improvement on the IGA score at the End of Treatment. IGA score is used to evaluate the overall severity of rosacea using a 5-point scale from 0 (clear) to 4 (severe).
Measured: Baseline and End of Treatment (up to 12 weeks)
Absolute change in inflammatory lesion count
Inflammatory lesions include papules and pustules on the face, and are counted by study personnel.
Measured: Baseline and End of Treatment (up to 12 weeks)
Secondary outcomes (4)
Treatment "Success Rate" based on change in IGA (interim time points)
IGA Score Success Rate is the same as defined in the Primary Outcome Measures.
Measured: Baseline, Week 4 and Week 8
Absolute change in inflammatory lesion count (interim time points)
Inflammatory lesions include papules and pustules on the face, and are counted by study personnel.
Measured: Baseline, Week 4 and Week 8
Change in erythema severity
The investigator will assess the erythema (skin redness) on the entire face, using a grading scale from 0 (none) to 4 (very severe)
Measured: Baseline and End of Treatment (up to 12 weeks)
Change in telangiectasia severity
The investigator will assess telangiectasia (small dilated blood vessels near the surface of the skin) on the face, using a grading scale of 0 (none) to 3 (severe).
Measured: Baseline and End of Treatment (up to 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
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
- Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PreCision Dermatology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Syd Dromgoole, PhD, Study director, Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828177
- Sponsor's protocol ID
- 172-7451-201
- Status last verified
- May 2014
- First submitted
- 3 Apr 2013
- Last updated
- 29 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Evaluator-Blinded Vehicle-Controlled Parallel Group Evaluation of Twice Daily PDI-320 in Comparison to Its Monads in Adults With Rosacea
- ClinicalTrials.gov ID
- NCT01828177
- Acronym / sponsor ID
- 172-7451-201
- Conditions
- Rosacea
- Keywords
- PreCision, PDI-320, Foam
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- PreCision Dermatology, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 10 Apr 2013 (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.
This 4-arm Phase 2 vehicle-controlled study is designed to assess the safety and efficacy of PDI-320, and the individual components, in adult subjects with rosacea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PDI-320 | Experimental | Drug: PDI-320Foam, twice daily for up to 12 weeks |
| PDI-320 Monad #1 | Experimental | Drug: PDI-320 Monad #1Foam, twice daily for up to 12 weeks |
| PDI-320 Monad #2 | Experimental | Drug: PDI-320 Monad #2Foam, twice daily for up to 12 weeks |
| Vehicle | Placebo comparator | Drug: VehicleFoam, twice daily for up to 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject has moderate to severe papulopustular rosacea and at least mild erythema and mild telangiectasia.
- Subject is willing and able to apply the test article(s) as directed, comply with study instructions and commit to all follow-up visits for the duration of the study.
- If subject is a woman of childbearing potential, she must have a negative urine pregnancy test and agree to use an effective form of birth control for the duration of the study.
Key exclusion criteria (11 listed)
- Subject is pregnant, lactating or is planning to become pregnant during the study.
- Subject has any other active dermatological condition on the face that may interfere with the conduct of the study.
- Subject has used systemic immunosuppressants within 30 days prior to study start.
- Subject has used systemic retinoids within 6 months prior to study start.
- Subject has used any topical rosacea therapy within 14 days prior to study start.
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 |
|---|---|---|
| PDI-320 | Drug | PDI-320 |
| PDI-320 Monad #1 | Drug | PDI-320 Monad #1 |
| PDI-320 Monad #2 | Drug | PDI-320 Monad #2 |
| Vehicle | Drug | Vehicle |
Primary outcome
Treatment "Success Rate" based on change in Investigator's Global Assessment (IGA)
Time frame: Baseline and End of Treatment (up to 12 weeks)
IGA Score Success Rate is defined as the percentage of subjects who achieve "Clear" (score = 0) or "Almost Clear" (score = 1) and have at least a 2-grade improvement on the IGA score at the End of Treatment. IGA score is used to evaluate the overall severity of rosacea using a 5-point scale from 0 (clear) to 4 (severe).
Absolute change in inflammatory lesion count
Time frame: Baseline and End of Treatment (up to 12 weeks)
Inflammatory lesions include papules and pustules on the face, and are counted by study personnel.
4 secondary outcomes
Treatment "Success Rate" based on change in IGA (interim time points)
Time frame: Baseline, Week 4 and Week 8
Absolute change in inflammatory lesion count (interim time points)
Time frame: Baseline, Week 4 and Week 8
Change in erythema severity
Time frame: Baseline and End of Treatment (up to 12 weeks)
Change in telangiectasia severity
Time frame: Baseline and End of Treatment (up to 12 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2014.
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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.
Syd Dromgoole, PhD study director
Therapeutics, Inc.
2 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 PDI-320, PDI-320 Monad #1 and PDI-320 Monad #2 in people with Rosacea, run by PreCision Dermatology, Inc. at 2 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 3 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: status not confirmed, as of the sponsor's last update on 29 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
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?
Treatment "Success Rate" based on change in Investigator's Global Assessment (IGA) (time frame: Baseline and End of Treatment (up to 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 29 May 2014.