Back to resultsSafety and Efficacy Study of A Novel Ointment to Treat Plaque Type Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
AN2728
AN2728 Ointment Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring Plaque Type Psoriasis, Topical
Eligibility Criteria
Inclusion Criteria:
- Male or female >18 years of age at time of enrollment.
- The clinical diagnosis of stable plaque psoriasis.
Two target plaques of similar severity
- ≥ 5 cm2 but ≤ 100 cm2 computed by multiplying the greatest diameter of the plaque by the diameter of the plaque perpendicular to the greatest diameter.
- Bilaterally located (right/left) plaques on the arms or plaques located on the upper and lower trunk. Plaques located on the trunk were to be separated by at least 10 cm and designated by the Investigator as either left/right or front/back.
- Target plaque severity score of 2-4 (mild to moderate).
- Normal or not clinically significant screening laboratory results.
- Subjects who were willing and able to apply study drug as directed, comply with study instructions, and commit to all follow-up visits.
- Subjects who had the ability to understand, agree to and sign the study Informed Consent Form (ICF) prior to initiation of any protocol related procedures.
Exclusion Criteria:
- Any dermatological conditions that could interfere with clinical evaluations or any disease state or physical condition which might expose the patient to an unacceptable risk by study participation
- Any underlying disease(s) or other dermatological conditions that require the use of exclusionary topical or systemic therapy (see below)
- Known sensitivity to any of the components of the study medication
- Spontaneously improving or rapidly deteriorating psoriatic plaques or pustular/exfoliative, guttate, erythrodermic or other non-plaque form of psoriasis
- Concomitant use of topical or systemic therapies that might alter the course of psoriasis
- Females of child bearing potential. Females must be post-menopausal (based on FSH levels) or surgically sterile (oophorectomy)
Washout periods of:
- Topical drugs that might alter the course of psoriasis: 2 weeks
- Oral retinoids: 8 weeks
- Non-retinoid systemic drugs that might alter the course of psoriasis: 4 weeks
- PUVA: 4 weeks
- UVB therapy: 4 weeks
- Use of emollients/moisturizers on area(s) to be treated: 2 days prior to baseline visit
- AIDS or AIDS related illness
- Concurrent participation in another drug research study or within 30 days of enrollment
- Use of lithium or hydroxychloroquine containing products (i.e. Plaquenil)
- Use of a beta-blocking medication (i.e. propranolol) if the dose has not been stabilized for at least 3 months
Sites / Locations
- IMIC
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
AN2728 Ointment, 5%
AN2728 Ointment Vehicle
Outcomes
Primary Outcome Measures
Percentage of Participants With Greater Decrease in Overall Target Plaque Severity Score (OTPSS) at Day 28
OTPSS is a scale to assess plaque severity. Each target plaque was scored on a severity rating scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS at Day 28 were reported and comparison of ointment and vehicle treated plaque was given as 'Ointment treated plaque versus (vs.) vehicle treated plaque' and 'Vehicle treated plaque vs. ointment treated plaque'.
Secondary Outcome Measures
Change From Baseline in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21, 28 and 35
OTPSS is a scale to assess plaque severity. Each target plaque was scored on a severity scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque.
Change From Baseline in Erythema at Day 7,14, 21, 28 and 35
Erythema is used to assess plaque severity. Investigator rated the clinical appearance of erythema on a severity scale, ranging from 0 (no color on plaque, no erythema) to 8 (extreme red color on plaque, severe erythema), where higher score indicated more severe condition.
Change From Baseline in Scaling at Day 7,14, 21, 28 and 35
Scaling is a scale to assess plaque severity. Investigator rated the clinical appearance of scaling on a severity scale, ranging from 0 (no scaling on plaque) to 8 (very thick scales on plaque), where higher score indicated more severe condition.
Change From Baseline in Plaque Elevation at Day 7,14, 21, 28 and 35
Plaque elevation is a scale to assess plaque severity. Investigator rated presence of plaque elevation on a severity scale ranging, from 0 (no plaque elevation) to 8 (very marked plaque elevation), where higher score indicated more severe condition.
Percentage of Participants With Greater Decrease in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21 and 35
OTPSS is a scale to assess plaque severity. Each target plaque was scored on a severity rating scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS at Day 7, 14, 21 and 35 were reported and comparison of ointment and vehicle treated plaque was given as 'Ointment treated plaque vs. vehicle treated plaque' and 'Vehicle treated plaque vs. ointment treated plaque'.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00759161
Brief Title
Safety and Efficacy Study of A Novel Ointment to Treat Plaque Type Psoriasis
Official Title
A Double-Blind, Randomized Bilateral Study of the Safety and Efficacy of AN2728 Ointment, 5%, Versus Ointment Vehicle in the Treatment of Patients With Plaque Type Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to determine the safety and efficacy of AN2728 Ointment, 5%, compared to Ointment Vehicle in the treatment of plaque type psoriasis.
Detailed Description
This is a multi-center, randomized, double-blind bilateral design. Patients will apply the test articles, AN2728 Ointment, 5%, and Ointment Vehicle twice daily. The assigned study medication will be applied to two comparable treatment targeted plaques identified at baseline. One test article will be applied to one plaque and the other test article to an anatomically distinct plaque. All efficacy evaluations will be measured from only the two plaques identified at the baseline visit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Plaque Type Psoriasis, Topical
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
AN2728 Ointment, 5%
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
AN2728 Ointment Vehicle
Intervention Type
Drug
Intervention Name(s)
AN2728
Other Intervention Name(s)
AN2728 Ointment, 5%
Intervention Description
AN2728 Ointment, 5%, twice daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
AN2728 Ointment Vehicle
Intervention Description
AN2728 Ointment Vehicle, twice daily for 4 weeks.
Primary Outcome Measure Information:
Title
Percentage of Participants With Greater Decrease in Overall Target Plaque Severity Score (OTPSS) at Day 28
Description
OTPSS is a scale to assess plaque severity. Each target plaque was scored on a severity rating scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS at Day 28 were reported and comparison of ointment and vehicle treated plaque was given as 'Ointment treated plaque versus (vs.) vehicle treated plaque' and 'Vehicle treated plaque vs. ointment treated plaque'.
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Change From Baseline in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21, 28 and 35
Description
OTPSS is a scale to assess plaque severity. Each target plaque was scored on a severity scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque.
Time Frame
Baseline (Day 1), Day 7,14, 21, 28, 35
Title
Change From Baseline in Erythema at Day 7,14, 21, 28 and 35
Description
Erythema is used to assess plaque severity. Investigator rated the clinical appearance of erythema on a severity scale, ranging from 0 (no color on plaque, no erythema) to 8 (extreme red color on plaque, severe erythema), where higher score indicated more severe condition.
Time Frame
Baseline (Day 1), Day 7,14, 21, 28, 35
Title
Change From Baseline in Scaling at Day 7,14, 21, 28 and 35
Description
Scaling is a scale to assess plaque severity. Investigator rated the clinical appearance of scaling on a severity scale, ranging from 0 (no scaling on plaque) to 8 (very thick scales on plaque), where higher score indicated more severe condition.
Time Frame
Baseline (Day 1), Day 7,14, 21, 28, 35
Title
Change From Baseline in Plaque Elevation at Day 7,14, 21, 28 and 35
Description
Plaque elevation is a scale to assess plaque severity. Investigator rated presence of plaque elevation on a severity scale ranging, from 0 (no plaque elevation) to 8 (very marked plaque elevation), where higher score indicated more severe condition.
Time Frame
Baseline (Day 1), Day 7,14, 21, 28, 35
Title
Percentage of Participants With Greater Decrease in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21 and 35
Description
OTPSS is a scale to assess plaque severity. Each target plaque was scored on a severity rating scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS at Day 7, 14, 21 and 35 were reported and comparison of ointment and vehicle treated plaque was given as 'Ointment treated plaque vs. vehicle treated plaque' and 'Vehicle treated plaque vs. ointment treated plaque'.
Time Frame
Day 7,14, 21, 35
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female >18 years of age at time of enrollment.
The clinical diagnosis of stable plaque psoriasis.
Two target plaques of similar severity
≥ 5 cm2 but ≤ 100 cm2 computed by multiplying the greatest diameter of the plaque by the diameter of the plaque perpendicular to the greatest diameter.
Bilaterally located (right/left) plaques on the arms or plaques located on the upper and lower trunk. Plaques located on the trunk were to be separated by at least 10 cm and designated by the Investigator as either left/right or front/back.
Target plaque severity score of 2-4 (mild to moderate).
Normal or not clinically significant screening laboratory results.
Subjects who were willing and able to apply study drug as directed, comply with study instructions, and commit to all follow-up visits.
Subjects who had the ability to understand, agree to and sign the study Informed Consent Form (ICF) prior to initiation of any protocol related procedures.
Exclusion Criteria:
Any dermatological conditions that could interfere with clinical evaluations or any disease state or physical condition which might expose the patient to an unacceptable risk by study participation
Any underlying disease(s) or other dermatological conditions that require the use of exclusionary topical or systemic therapy (see below)
Known sensitivity to any of the components of the study medication
Spontaneously improving or rapidly deteriorating psoriatic plaques or pustular/exfoliative, guttate, erythrodermic or other non-plaque form of psoriasis
Concomitant use of topical or systemic therapies that might alter the course of psoriasis
Females of child bearing potential. Females must be post-menopausal (based on FSH levels) or surgically sterile (oophorectomy)
Washout periods of:
Topical drugs that might alter the course of psoriasis: 2 weeks
Oral retinoids: 8 weeks
Non-retinoid systemic drugs that might alter the course of psoriasis: 4 weeks
PUVA: 4 weeks
UVB therapy: 4 weeks
Use of emollients/moisturizers on area(s) to be treated: 2 days prior to baseline visit
AIDS or AIDS related illness
Concurrent participation in another drug research study or within 30 days of enrollment
Use of lithium or hydroxychloroquine containing products (i.e. Plaquenil)
Use of a beta-blocking medication (i.e. propranolol) if the dose has not been stabilized for at least 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
IMIC
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
06700
Country
Mexico
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Study of A Novel Ointment to Treat Plaque Type Psoriasis
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