Trial Outcomes & Findings for Safety and Efficacy Study of A Novel Ointment to Treat Plaque Type Psoriasis (NCT NCT00759161)
NCT ID: NCT00759161
Last Updated: 2017-03-06
Results Overview
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'.
COMPLETED
PHASE2
35 participants
Day 28
2017-03-06
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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35
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Overall Study
COMPLETED
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35
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Study of A Novel Ointment to Treat Plaque Type Psoriasis
Baseline characteristics by cohort
| Measure |
AN2728 5% Ointment + Ointment Vehicle
n=35 Participants
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.
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|---|---|
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Age, Continuous
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45.0 years
STANDARD_DEVIATION 9.03 • n=99 Participants
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Gender
Female
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0 Participants
n=99 Participants
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Gender
Male
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35 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: Day 28Population: ITT population included all randomized participants who received at least 1 dose of study drug.
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'.
Outcome measures
| Measure |
AN2728 5% Ointment + Ointment Vehicle
n=35 Participants
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.
|
AN2728 Ointment Vehicle
AN2728 ointment vehicle was applied to 1 of the 2 comparable and anatomically distinct treatment-targeted plaques within each participant, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
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|---|---|---|
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Percentage of Participants With Greater Decrease in Overall Target Plaque Severity Score (OTPSS) at Day 28
Ointment treated plaque vs. vehicle treated plaque
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68.6 percentage of participants
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—
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Percentage of Participants With Greater Decrease in Overall Target Plaque Severity Score (OTPSS) at Day 28
Vehicle treated plaque vs. ointment treated plaque
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5.7 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 7,14, 21, 28, 35Population: ITT population included all randomized participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
AN2728 5% Ointment + Ointment Vehicle
n=35 Participants
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.
|
AN2728 Ointment Vehicle
n=35 Participants
AN2728 ointment vehicle was applied to 1 of the 2 comparable and anatomically distinct treatment-targeted plaques within each participant, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
|
|---|---|---|
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Change From Baseline in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21, 28 and 35
Baseline
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2.8 units on a scale
Standard Deviation 0.53
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2.8 units on a scale
Standard Deviation 0.53
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Change From Baseline in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21, 28 and 35
Change at Day 7
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0.17 units on a scale
Standard Deviation 0.453
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0.11 units on a scale
Standard Deviation 0.404
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Change From Baseline in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21, 28 and 35
Change at Day 14
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0.71 units on a scale
Standard Deviation 0.572
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0.31 units on a scale
Standard Deviation 0.583
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Change From Baseline in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21, 28 and 35
Change at Day 21
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1.06 units on a scale
Standard Deviation 0.539
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0.49 units on a scale
Standard Deviation 0.658
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Change From Baseline in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21, 28 and 35
Change at Day 28
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1.40 units on a scale
Standard Deviation 0.497
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0.66 units on a scale
Standard Deviation 0.684
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Change From Baseline in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21, 28 and 35
Change at Day 35
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1.26 units on a scale
Standard Deviation 0.505
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0.57 units on a scale
Standard Deviation 0.655
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SECONDARY outcome
Timeframe: Baseline (Day 1), Day 7,14, 21, 28, 35Population: ITT population included all randomized participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
AN2728 5% Ointment + Ointment Vehicle
n=35 Participants
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.
|
AN2728 Ointment Vehicle
n=35 Participants
AN2728 ointment vehicle was applied to 1 of the 2 comparable and anatomically distinct treatment-targeted plaques within each participant, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
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|---|---|---|
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Change From Baseline in Erythema at Day 7,14, 21, 28 and 35
Baseline
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2.8 units on a scale
Standard Deviation 0.62
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2.8 units on a scale
Standard Deviation 0.57
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Change From Baseline in Erythema at Day 7,14, 21, 28 and 35
Change at Day 7
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0.31 units on a scale
Standard Deviation 0.631
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0.14 units on a scale
Standard Deviation 0.430
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Change From Baseline in Erythema at Day 7,14, 21, 28 and 35
Change at Day 14
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0.63 units on a scale
Standard Deviation 0.731
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0.29 units on a scale
Standard Deviation 0.622
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Change From Baseline in Erythema at Day 7,14, 21, 28 and 35
Change at Day 21
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1.09 units on a scale
Standard Deviation 0.658
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0.40 units on a scale
Standard Deviation 0.695
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Change From Baseline in Erythema at Day 7,14, 21, 28 and 35
Change at Day 28
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1.40 units on a scale
Standard Deviation 0.651
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0.60 units on a scale
Standard Deviation 0.736
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Change From Baseline in Erythema at Day 7,14, 21, 28 and 35
Change at Day 35
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1.37 units on a scale
Standard Deviation 0.770
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0.57 units on a scale
Standard Deviation 0.778
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SECONDARY outcome
Timeframe: Baseline (Day 1), Day 7,14, 21, 28, 35Population: ITT population included all randomized participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
AN2728 5% Ointment + Ointment Vehicle
n=35 Participants
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.
|
AN2728 Ointment Vehicle
n=35 Participants
AN2728 ointment vehicle was applied to 1 of the 2 comparable and anatomically distinct treatment-targeted plaques within each participant, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
|
|---|---|---|
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Change From Baseline in Scaling at Day 7,14, 21, 28 and 35
Baseline
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3.2 units on a scale
Standard Deviation 0.73
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3.1 units on a scale
Standard Deviation 0.63
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Change From Baseline in Scaling at Day 7,14, 21, 28 and 35
Change at Day 7
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0.69 units on a scale
Standard Deviation 0.676
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0.43 units on a scale
Standard Deviation 0.502
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Change From Baseline in Scaling at Day 7,14, 21, 28 and 35
Change at Day 14
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1.29 units on a scale
Standard Deviation 0.667
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0.89 units on a scale
Standard Deviation 0.631
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Change From Baseline in Scaling at Day 7,14, 21, 28 and 35
Change at Day 21
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1.60 units on a scale
Standard Deviation 0.812
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0.94 units on a scale
Standard Deviation 0.725
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Change From Baseline in Scaling at Day 7,14, 21, 28 and 35
Change at Day 28
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1.83 units on a scale
Standard Deviation 0.747
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1.09 units on a scale
Standard Deviation 0.818
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Change From Baseline in Scaling at Day 7,14, 21, 28 and 35
Change at Day 35
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1.66 units on a scale
Standard Deviation 0.838
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0.91 units on a scale
Standard Deviation 0.742
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SECONDARY outcome
Timeframe: Baseline (Day 1), Day 7,14, 21, 28, 35Population: ITT population included all randomized participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
AN2728 5% Ointment + Ointment Vehicle
n=35 Participants
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.
|
AN2728 Ointment Vehicle
n=35 Participants
AN2728 ointment vehicle was applied to 1 of the 2 comparable and anatomically distinct treatment-targeted plaques within each participant, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
|
|---|---|---|
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Change From Baseline in Plaque Elevation at Day 7,14, 21, 28 and 35
Change at Day 35
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1.20 units on a scale
Standard Deviation 0.632
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0.43 units on a scale
Standard Deviation 0.655
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Change From Baseline in Plaque Elevation at Day 7,14, 21, 28 and 35
Baseline
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2.7 units on a scale
Standard Deviation 0.61
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2.7 units on a scale
Standard Deviation 0.58
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Change From Baseline in Plaque Elevation at Day 7,14, 21, 28 and 35
Change at Day 7
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0.17 units on a scale
Standard Deviation 0.453
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0.03 units on a scale
Standard Deviation 0.296
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Change From Baseline in Plaque Elevation at Day 7,14, 21, 28 and 35
Change at Day 14
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0.49 units on a scale
Standard Deviation 0.562
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0.26 units on a scale
Standard Deviation 0.611
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Change From Baseline in Plaque Elevation at Day 7,14, 21, 28 and 35
Change at Day 21
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0.83 units on a scale
Standard Deviation 0.707
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0.26 units on a scale
Standard Deviation 0.611
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Change From Baseline in Plaque Elevation at Day 7,14, 21, 28 and 35
Change at Day 28
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1.23 units on a scale
Standard Deviation 0.731
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0.40 units on a scale
Standard Deviation 0.604
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SECONDARY outcome
Timeframe: Day 7,14, 21, 35Population: ITT population included all randomized participants who received at least 1 dose of study drug.
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'.
Outcome measures
| Measure |
AN2728 5% Ointment + Ointment Vehicle
n=35 Participants
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.
|
AN2728 Ointment Vehicle
AN2728 ointment vehicle was applied to 1 of the 2 comparable and anatomically distinct treatment-targeted plaques within each participant, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
|
|---|---|---|
|
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
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11.4 percentage of participants
|
—
|
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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
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5.7 percentage of participants
|
—
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|
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
|
—
|
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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
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8.6 percentage of participants
|
—
|
|
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
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54.3 percentage of participants
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—
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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
|
—
|
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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
|
—
|
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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
|
—
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Adverse Events
AN2728 5% Ointment + Ointment Vehicle
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AN2728 5% Ointment + Ointment Vehicle
n=35 participants at risk
AN2728 ointment, 5 percent (%) and ointment vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques within each participant, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
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|---|---|
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Gastrointestinal disorders
Diarrhoea
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2.9%
1/35
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Gastrointestinal disorders
Gingivitis
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2.9%
1/35
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER