Psoriasis
Conditions
Keywords
Plaque Type Psoriasis, Topical
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.
Interventions
DRUGAN2728
AN2728 Ointment, 5%, twice daily for 4 weeks
AN2728 Ointment Vehicle, twice daily for 4 weeks.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female \>18 years of age at time of enrollment. 2. The clinical diagnosis of stable plaque psoriasis. 3. Two target plaques of similar severity 1. ≥ 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. 2. 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. 3. Target plaque severity score of 2-4 (mild to moderate). 4. Normal or not clinically significant screening laboratory results. 5. Subjects who were willing and able to apply study drug as directed, comply with study instructions, and commit to all follow-up visits. 6. 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
1. 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 2. Any underlying disease(s) or other dermatological conditions that require the use of exclusionary topical or systemic therapy (see below) 3. Known sensitivity to any of the components of the study medication 4. Spontaneously improving or rapidly deteriorating psoriatic plaques or pustular/exfoliative, guttate, erythrodermic or other non-plaque form of psoriasis 5. Concomitant use of topical or systemic therapies that might alter the course of psoriasis 6. Females of child bearing potential. Females must be post-menopausal (based on FSH levels) or surgically sterile (oophorectomy) 7. Washout periods of: 1. Topical drugs that might alter the course of psoriasis: 2 weeks 2. Oral retinoids: 8 weeks 3. Non-retinoid systemic drugs that might alter the course of psoriasis: 4 weeks 4. PUVA: 4 weeks 5. UVB therapy: 4 weeks 6. Use of emollients/moisturizers on area(s) to be treated: 2 days prior to baseline visit 8. AIDS or AIDS related illness 9. Concurrent participation in another drug research study or within 30 days of enrollment 10. Use of lithium or hydroxychloroquine containing products (i.e. Plaquenil) 11. Use of a beta-blocking medication (i.e. propranolol) if the dose has not been stabilized for at least 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Greater Decrease in Overall Target Plaque Severity Score (OTPSS) at Day 28 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21, 28 and 35 | Baseline (Day 1), Day 7,14, 21, 28, 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 | Baseline (Day 1), Day 7,14, 21, 28, 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 | Baseline (Day 1), Day 7,14, 21, 28, 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 | Baseline (Day 1), Day 7,14, 21, 28, 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 | Day 7,14, 21, 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'. |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AN2728 5% Ointment + Ointment Vehicle AN2728 ointment, 5 percent (%) and ointment vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques within each participant respectively, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator. | 35 |
| Total | 35 |
Baseline characteristics
| Characteristic | AN2728 5% Ointment + Ointment Vehicle |
|---|---|
| Age, Continuous | 45.0 years STANDARD_DEVIATION 9.03 |
| Gender Female | 0 Participants |
| Gender Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 35 |
| serious Total, serious adverse events | 0 / 35 |
Outcome results
Primary
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'.
Time frame: Day 28
Population: ITT population included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AN2728 5% Ointment + Ointment Vehicle | Percentage of Participants With Greater Decrease in Overall Target Plaque Severity Score (OTPSS) at Day 28 | Ointment treated plaque vs. vehicle treated plaque | 68.6 percentage of participants |
| AN2728 5% Ointment + Ointment Vehicle | Percentage of Participants With Greater Decrease in Overall Target Plaque Severity Score (OTPSS) at Day 28 | Vehicle treated plaque vs. ointment treated plaque | 5.7 percentage of participants |
p-value: <0.0012-sided sign test
Secondary
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.
Time frame: Baseline (Day 1), Day 7,14, 21, 28, 35
Population: ITT population included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AN2728 5% Ointment + Ointment Vehicle | Change From Baseline in Erythema at Day 7,14, 21, 28 and 35 | Baseline | 2.8 units on a scale | Standard Deviation 0.62 |
| AN2728 5% Ointment + Ointment Vehicle | Change From Baseline in Erythema at Day 7,14, 21, 28 and 35 | Change at Day 7 | 0.31 units on a scale | Standard Deviation 0.631 |
| AN2728 5% Ointment + Ointment Vehicle | Change From Baseline in Erythema at Day 7,14, 21, 28 and 35 | Change at Day 14 | 0.63 units on a scale | Standard Deviation 0.731 |
| AN2728 5% Ointment + Ointment Vehicle | Change From Baseline in Erythema at Day 7,14, 21, 28 and 35 | Change at Day 21 | 1.09 units on a scale | Standard Deviation 0.658 |
| AN2728 5% Ointment + Ointment Vehicle | Change From Baseline in Erythema at Day 7,14, 21, 28 and 35 | Change at Day 28 | 1.40 units on a scale | Standard Deviation 0.651 |
| AN2728 5% Ointment + Ointment Vehicle | Change From Baseline in Erythema at Day 7,14, 21, 28 and 35 | Change at Day 35 | 1.37 units on a scale | Standard Deviation 0.77 |
| AN2728 Ointment Vehicle | Change From Baseline in Erythema at Day 7,14, 21, 28 and 35 | Change at Day 28 | 0.60 units on a scale | Standard Deviation 0.736 |
| AN2728 Ointment Vehicle | Change From Baseline in Erythema at Day 7,14, 21, 28 and 35 | Baseline | 2.8 units on a scale | Standard Deviation 0.57 |
| AN2728 Ointment Vehicle | Change From Baseline in Erythema at Day 7,14, 21, 28 and 35 | Change at Day 21 | 0.40 units on a scale | Standard Deviation 0.695 |
| AN2728 Ointment Vehicle | Change From Baseline in Erythema at Day 7,14, 21, 28 and 35 | Change at Day 7 | 0.14 units on a scale | Standard Deviation 0.43 |
| AN2728 Ointment Vehicle | Change From Baseline in Erythema at Day 7,14, 21, 28 and 35 | Change at Day 35 | 0.57 units on a scale | Standard Deviation 0.778 |
| AN2728 Ointment Vehicle | Change From Baseline in Erythema at Day 7,14, 21, 28 and 35 | Change at Day 14 | 0.29 units on a scale | Standard Deviation 0.622 |
Secondary
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.
Time frame: Baseline (Day 1), Day 7,14, 21, 28, 35
Population: ITT population included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AN2728 5% Ointment + Ointment Vehicle | Change From Baseline in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21, 28 and 35 | Baseline | 2.8 units on a scale | Standard Deviation 0.53 |
| AN2728 5% Ointment + Ointment Vehicle | Change From Baseline in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21, 28 and 35 | Change at Day 7 | 0.17 units on a scale | Standard Deviation 0.453 |
| AN2728 5% Ointment + Ointment Vehicle | Change From Baseline in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21, 28 and 35 | Change at Day 14 | 0.71 units on a scale | Standard Deviation 0.572 |
| AN2728 5% Ointment + Ointment Vehicle | Change From Baseline in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21, 28 and 35 | Change at Day 21 | 1.06 units on a scale | Standard Deviation 0.539 |
| AN2728 5% Ointment + Ointment Vehicle | Change From Baseline in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21, 28 and 35 | Change at Day 28 | 1.40 units on a scale | Standard Deviation 0.497 |
| AN2728 5% Ointment + Ointment Vehicle | Change From Baseline in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21, 28 and 35 | Change at Day 35 | 1.26 units on a scale | Standard Deviation 0.505 |
| AN2728 Ointment Vehicle | Change From Baseline in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21, 28 and 35 | Change at Day 28 | 0.66 units on a scale | Standard Deviation 0.684 |
| AN2728 Ointment Vehicle | Change From Baseline in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21, 28 and 35 | Baseline | 2.8 units on a scale | Standard Deviation 0.53 |
| AN2728 Ointment Vehicle | Change From Baseline in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21, 28 and 35 | Change at Day 21 | 0.49 units on a scale | Standard Deviation 0.658 |
| AN2728 Ointment Vehicle | Change From Baseline in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21, 28 and 35 | Change at Day 7 | 0.11 units on a scale | Standard Deviation 0.404 |
| AN2728 Ointment Vehicle | Change From Baseline in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21, 28 and 35 | Change at Day 35 | 0.57 units on a scale | Standard Deviation 0.655 |
| AN2728 Ointment Vehicle | Change From Baseline in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21, 28 and 35 | Change at Day 14 | 0.31 units on a scale | Standard Deviation 0.583 |
Secondary
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.
Time frame: Baseline (Day 1), Day 7,14, 21, 28, 35
Population: ITT population included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AN2728 5% Ointment + Ointment Vehicle | Change From Baseline in Plaque Elevation at Day 7,14, 21, 28 and 35 | Change at Day 7 | 0.17 units on a scale | Standard Deviation 0.453 |
| AN2728 5% Ointment + Ointment Vehicle | Change From Baseline in Plaque Elevation at Day 7,14, 21, 28 and 35 | Baseline | 2.7 units on a scale | Standard Deviation 0.61 |
| AN2728 5% Ointment + Ointment Vehicle | Change From Baseline in Plaque Elevation at Day 7,14, 21, 28 and 35 | Change at Day 28 | 1.23 units on a scale | Standard Deviation 0.731 |
| AN2728 5% Ointment + Ointment Vehicle | Change From Baseline in Plaque Elevation at Day 7,14, 21, 28 and 35 | Change at Day 14 | 0.49 units on a scale | Standard Deviation 0.562 |
| AN2728 5% Ointment + Ointment Vehicle | Change From Baseline in Plaque Elevation at Day 7,14, 21, 28 and 35 | Change at Day 35 | 1.20 units on a scale | Standard Deviation 0.632 |
| AN2728 5% Ointment + Ointment Vehicle | Change From Baseline in Plaque Elevation at Day 7,14, 21, 28 and 35 | Change at Day 21 | 0.83 units on a scale | Standard Deviation 0.707 |
| AN2728 Ointment Vehicle | Change From Baseline in Plaque Elevation at Day 7,14, 21, 28 and 35 | Change at Day 35 | 0.43 units on a scale | Standard Deviation 0.655 |
| AN2728 Ointment Vehicle | Change From Baseline in Plaque Elevation at Day 7,14, 21, 28 and 35 | Baseline | 2.7 units on a scale | Standard Deviation 0.58 |
| AN2728 Ointment Vehicle | Change From Baseline in Plaque Elevation at Day 7,14, 21, 28 and 35 | Change at Day 7 | 0.03 units on a scale | Standard Deviation 0.296 |
| AN2728 Ointment Vehicle | Change From Baseline in Plaque Elevation at Day 7,14, 21, 28 and 35 | Change at Day 14 | 0.26 units on a scale | Standard Deviation 0.611 |
| AN2728 Ointment Vehicle | Change From Baseline in Plaque Elevation at Day 7,14, 21, 28 and 35 | Change at Day 21 | 0.26 units on a scale | Standard Deviation 0.611 |
| AN2728 Ointment Vehicle | Change From Baseline in Plaque Elevation at Day 7,14, 21, 28 and 35 | Change at Day 28 | 0.40 units on a scale | Standard Deviation 0.604 |
Secondary
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.
Time frame: Baseline (Day 1), Day 7,14, 21, 28, 35
Population: ITT population included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AN2728 5% Ointment + Ointment Vehicle | Change From Baseline in Scaling at Day 7,14, 21, 28 and 35 | Baseline | 3.2 units on a scale | Standard Deviation 0.73 |
| AN2728 5% Ointment + Ointment Vehicle | Change From Baseline in Scaling at Day 7,14, 21, 28 and 35 | Change at Day 7 | 0.69 units on a scale | Standard Deviation 0.676 |
| AN2728 5% Ointment + Ointment Vehicle | Change From Baseline in Scaling at Day 7,14, 21, 28 and 35 | Change at Day 14 | 1.29 units on a scale | Standard Deviation 0.667 |
| AN2728 5% Ointment + Ointment Vehicle | Change From Baseline in Scaling at Day 7,14, 21, 28 and 35 | Change at Day 21 | 1.60 units on a scale | Standard Deviation 0.812 |
| AN2728 5% Ointment + Ointment Vehicle | Change From Baseline in Scaling at Day 7,14, 21, 28 and 35 | Change at Day 28 | 1.83 units on a scale | Standard Deviation 0.747 |
| AN2728 5% Ointment + Ointment Vehicle | Change From Baseline in Scaling at Day 7,14, 21, 28 and 35 | Change at Day 35 | 1.66 units on a scale | Standard Deviation 0.838 |
| AN2728 Ointment Vehicle | Change From Baseline in Scaling at Day 7,14, 21, 28 and 35 | Change at Day 28 | 1.09 units on a scale | Standard Deviation 0.818 |
| AN2728 Ointment Vehicle | Change From Baseline in Scaling at Day 7,14, 21, 28 and 35 | Baseline | 3.1 units on a scale | Standard Deviation 0.63 |
| AN2728 Ointment Vehicle | Change From Baseline in Scaling at Day 7,14, 21, 28 and 35 | Change at Day 21 | 0.94 units on a scale | Standard Deviation 0.725 |
| AN2728 Ointment Vehicle | Change From Baseline in Scaling at Day 7,14, 21, 28 and 35 | Change at Day 7 | 0.43 units on a scale | Standard Deviation 0.502 |
| AN2728 Ointment Vehicle | Change From Baseline in Scaling at Day 7,14, 21, 28 and 35 | Change at Day 35 | 0.91 units on a scale | Standard Deviation 0.742 |
| AN2728 Ointment Vehicle | Change From Baseline in Scaling at Day 7,14, 21, 28 and 35 | Change at Day 14 | 0.89 units on a scale | Standard Deviation 0.631 |
Secondary
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'.
Time frame: Day 7,14, 21, 35
Population: ITT population included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AN2728 5% Ointment + Ointment Vehicle | Percentage of Participants With Greater Decrease in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21 and 35 | Day 7: Ointment treated vs.vehicle treated plaque | 11.4 percentage of participants |
| AN2728 5% Ointment + Ointment Vehicle | Percentage of Participants With Greater Decrease in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21 and 35 | Day 7: Vehicle treated vs.ointment treated plaque | 5.7 percentage of participants |
| AN2728 5% Ointment + Ointment Vehicle | Percentage of Participants With Greater Decrease in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21 and 35 | Day 14: Ointment treated vs.vehicle treated plaque | 48.6 percentage of participants |
| AN2728 5% Ointment + Ointment Vehicle | Percentage of Participants With Greater Decrease in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21 and 35 | Day 14: Vehicle treated vs.ointment treated plaque | 8.6 percentage of participants |
| AN2728 5% Ointment + Ointment Vehicle | Percentage of Participants With Greater Decrease in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21 and 35 | Day 21:Ointment treated vs.vehicle treated plaque | 54.3 percentage of participants |
| AN2728 5% Ointment + Ointment Vehicle | Percentage of Participants With Greater Decrease in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21 and 35 | Day 21: Vehicle treated vs.ointment treated plaque | 2.9 percentage of participants |
| AN2728 5% Ointment + Ointment Vehicle | Percentage of Participants With Greater Decrease in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21 and 35 | Day 35:Ointment treated vs.vehicle treated plaque | 62.9 percentage of participants |
| AN2728 5% Ointment + Ointment Vehicle | Percentage of Participants With Greater Decrease in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21 and 35 | Day 35: Vehicle treated vs.ointment treated plaque | 2.9 percentage of participants |