Atopic DermatitisPhase 2NCT01826461
An Evaluation of PDI-192 0.1% in Comparison to PDI-192 0.15% in the Treatment of Mild to Moderate Atopic Dermatitis
A Phase 2 study testing PDI-192 in people with Atopic Dermatitis, run by PreCision Dermatology, Inc. at 9 sites in United States.
Trial summary
This study will compare the safety and efficacy of three test article foams (PDI-192 0.1% Foam, PDI-192 0.15% Foam, and Vehicle Foam) such that a final commercial product may be selected for future development. Read more about this study
- Who is it for?
- Ages 3 months to 17 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- PDI-192
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 151 participants
- Where
- 9 sitesUnited States
- Study dates
- Mar 2013to Dec 2013
- 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 3 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject presents with a clinical diagnosis of stable mild to moderate atopic dermatitis.
- Subject has used the same type of soap, moisturizers, lotions, creams, ointments, sunscreens or other skin products, and hair products (shampoo, etc.) for at least two weeks prior to study start and agrees to continue usage with the same products and with similar frequency for the entire study.
Who cannot join
- Subject is pregnant, lactating or is planning to become pregnant during the study.
- Subject requires any topical or systemic medications or is using topical inflammatory dermatoses therapies that could affect the course of their atopic dermatitis during the study period.
- Subject has used systemic corticosteroids, immunomodulators including leukotriene inhibitors, or antimetabolites within 30 days prior to study start.
- Subject has used Ultraviolet Light Therapy (PUVA, UVB, etc.) within 30 days prior to study start.
- Subject has used topical therapies for the treatment of (or may affect) their atopic dermatitis including but not limited to corticosteroids, immunomodulators (tacrolimus, pimecrolimus, etc.), tar, calcipotriene or other vitamin D preparations, retinoids, antihistamines (doxepin, diphenhydramine, etc.), antibiotics, among others, within 14 days prior to study start.
- Subject desires excessive or prolonged exposure to ultraviolet light (e.g., sunlight, tanning beds) during the study.
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- Subject has used systemic (oral, IV, etc.) antibiotic therapy within seven days prior to study start.
- 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 study start.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Academic Dermatology Associates
Albuquerque, New Mexico
DermResearch, Inc.
Austin, Texas
Northwestern University
Chicago, Illinois
Minnesota Clinical Study Center
Fridley, Minnesota
Dermatology Consulting Services
High Point, North Carolina
UT Houston Health Science Center
Houston, Texas
Virginia Clinical Research, Inc.
Norfolk, Virginia
Sneeze, Wheeze & Itch Associates, LLC
Normal, Illinois
UCSD - Rady Children's Hospital
San Diego, California
About this study
Official title: A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Evaluation of Twice Daily PDI-192 0.1% in Comparison to PDI-192 0.15% in the Treatment of Mild to Moderate Atopic Dermatitis in Subjects 3 Months to Less Than 18 Years of Age
This study will compare the safety and efficacy of three test article foams (PDI-192 0.1% Foam, PDI-192 0.15% Foam, and Vehicle Foam) such that a final commercial product may be selected for future development.
- Conditions
- Atopic Dermatitis
- Being tested
- PDI-192, Vehicle
- Keywords
- atopic dermatitis, eczema, PDI-192, Precision
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDI-192Drug
VehicleDrug
| Study group | Role | What they receive |
|---|---|---|
| PDI-192 Foam, 0.1% | Experimental | topical foam, 0.1% concentration, twice daily Receives: Drug: PDI-192 |
| PDI-192 Foam, 0.15% | Experimental | topical foam, 0.15% concentration, twice daily Receives: Drug: PDI-192 |
| Vehicle Foam | Placebo comparator | topical foam, 0% concentration, twice daily Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Treatment Success" based on change in Investigator's Global Assessment (IGA)
Success rate, based on IGA score. Success rate is defined as the percentage of subjects who achieve "Clear" (score = 0) or "Almost Clear" (score = 1) and at least a 2-grade improvement from Baseline on the IGA score at Day 29. IGA is a measure of overall severity of atopic dermatitis using a 5-point ordinal scale from 0 = clear to 4 = severe.
Measured: Baseline and Day 29
Secondary outcomes (1)
Change in Pruritis Severity at Day 29
Change from Baseline in the severity of pruritus (itching) at Day 29. Pruritis severity is based on a periodic subject assessment using a 4-point ordinal scale from 0 = none to 3 = severe.
Measured: Baseline and Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- 151 participants (actual)
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
- NCT01826461
- Sponsor's protocol ID
- 172-0151-202
- Status last verified
- May 2014
- First submitted
- 1 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, Double-Blind, Vehicle-Controlled, Parallel Group Evaluation of Twice Daily PDI-192 0.1% in Comparison to PDI-192 0.15% in the Treatment of Mild to Moderate Atopic Dermatitis in Subjects 3 Months to Less Than 18 Years of Age
- ClinicalTrials.gov ID
- NCT01826461
- Acronym / sponsor ID
- 172-0151-202
- Conditions
- Atopic Dermatitis
- Keywords
- atopic dermatitis, eczema, PDI-192, Precision
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- PreCision Dermatology, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 8 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 study will compare the safety and efficacy of three test article foams (PDI-192 0.1% Foam, PDI-192 0.15% Foam, and Vehicle Foam) such that a final commercial product may be selected for future development.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PDI-192 Foam, 0.1% | Experimental | Drug: PDI-192topical foam, 0.1% concentration, twice daily |
| PDI-192 Foam, 0.15% | Experimental | Drug: PDI-192topical foam, 0.15% concentration, twice daily |
| Vehicle Foam | Placebo comparator | Drug: Vehicletopical foam, 0% concentration, twice daily |
Who may qualify
- Ages
- 3 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Subject presents with a clinical diagnosis of stable mild to moderate atopic dermatitis.
- Subject has used the same type of soap, moisturizers, lotions, creams, ointments, sunscreens or other skin products, and hair products (shampoo, etc.) for at least two weeks prior to study start and agrees to continue usage with the same products and with similar frequency for the entire study.
Key exclusion criteria (9 listed)
- Subject is pregnant, lactating or is planning to become pregnant during the study.
- Subject requires any topical or systemic medications or is using topical inflammatory dermatoses therapies that could affect the course of their atopic dermatitis during the study period.
- Subject has used systemic corticosteroids, immunomodulators including leukotriene inhibitors, or antimetabolites within 30 days prior to study start.
- Subject has used Ultraviolet Light Therapy (PUVA, UVB, etc.) within 30 days prior to study start.
- Subject has used topical therapies for the treatment of (or may affect) their atopic dermatitis including but not limited to corticosteroids, immunomodulators (tacrolimus, pimecrolimus, etc.), tar, calcipotriene or other vitamin D preparations, retinoids, antihistamines (doxepin, diphenhydramine, etc.), antibiotics, among others, 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-192 | Drug | PDI-192 Foam, 0.1%, PDI-192 Foam, 0.15% |
| Vehicle | Drug | Vehicle Foam |
Primary outcome
"Treatment Success" based on change in Investigator's Global Assessment (IGA)
Time frame: Baseline and Day 29
Success rate, based on IGA score. Success rate is defined as the percentage of subjects who achieve "Clear" (score = 0) or "Almost Clear" (score = 1) and at least a 2-grade improvement from Baseline on the IGA score at Day 29. IGA is a measure of overall severity of atopic dermatitis using a 5-point ordinal scale from 0 = clear to 4 = severe.
1 secondary outcome
Change in Pruritis Severity at Day 29
Time frame: Baseline and Day 29
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 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.
9 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-192 in people with Atopic Dermatitis, run by PreCision Dermatology, Inc. at 9 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 9 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 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 9 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?
"Treatment Success" based on change in Investigator's Global Assessment (IGA) (time frame: Baseline and Day 29). 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.