Trial Outcomes & Findings for Safety and Efficacy Study of A Novel Ointment to Treat Plaque Type Psoriasis (NCT NCT00755196)
NCT ID: NCT00755196
Last Updated: 2017-03-06
Results Overview
OTPSS is a scale to assess plaque severity. Each target plaque was scored by the investigator on severity 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 84 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'.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Day 84
Results posted on
2017-03-06
Participant Flow
Participant milestones
| Measure |
AN2728 5 Percent (%) Ointment + Ointment Vehicle
AN2728 5 % ointment and ointment vehicle were applied to 2 comparable and anatomically distinct treatment-targeted plaques, respectively within each participant, twice daily for 12 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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30
|
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Overall Study
COMPLETED
|
28
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|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
AN2728 5 Percent (%) Ointment + Ointment Vehicle
AN2728 5 % ointment and ointment vehicle were applied to 2 comparable and anatomically distinct treatment-targeted plaques, respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
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|---|---|
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Overall Study
Lost to Follow-up
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1
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Overall Study
Lack of Efficiency
|
1
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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=30 Participants
AN2728 5 % ointment and ointment vehicle were applied to 2 comparable and anatomically distinct treatment-targeted plaques, respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
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|---|---|
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Age, Continuous
|
48.4 years
STANDARD_DEVIATION 8.63 • n=99 Participants
|
|
Gender
Female
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0 Participants
n=99 Participants
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Gender
Male
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30 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: Day 84Population: ITT population included all randomized participants who received the study medication.
OTPSS is a scale to assess plaque severity. Each target plaque was scored by the investigator on severity 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 84 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=30 Participants
AN2728 5 % ointment and ointment vehicle were applied to 2 comparable and anatomically distinct treatment-targeted plaques, respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
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|---|---|
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Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) at Day 84
Ointment treated plaque vs. vehicle treated plaque
|
53.3 percentage of participants
|
|
Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) at Day 84
Vehicle treated plaque vs. ointment treated plaque
|
30.0 percentage of participants
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SECONDARY outcome
Timeframe: Day 7, 14, 28, 42, 56, 70, 91Population: ITT population included all randomized participants who received the study medication.
OTPSS is a scale to assess plaque severity. Each target plaque was scored by the investigator on severity 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, 28, 42, 56, 70 and 91 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=30 Participants
AN2728 5 % ointment and ointment vehicle were applied to 2 comparable and anatomically distinct treatment-targeted plaques, respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
|
|---|---|
|
Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91
Day 91: Ointment treated vs.vehicle treated plaque
|
40.0 percentage of participants
|
|
Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91
Day 7: Ointment treated vs.vehicle treated plaque
|
10.0 percentage of participants
|
|
Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91
Day 7: Vehicle treated vs.ointment treated plaque
|
10.0 percentage of participants
|
|
Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91
Day 14: Ointment treated vs.vehicle treated plaque
|
43.3 percentage of participants
|
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Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91
Day 14: Vehicle treated vs.ointment treated plaque
|
10.0 percentage of participants
|
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Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91
Day 28: Ointment treated vs.vehicle treated plaque
|
60.0 percentage of participants
|
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Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91
Day 28: Vehicle treated vs.ointment treated plaque
|
3.3 percentage of participants
|
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Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91
Day 42: Ointment treated vs.vehicle treated plaque
|
60.0 percentage of participants
|
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Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91
Day 42: Vehicle treated vs.ointment treated plaque
|
6.7 percentage of participants
|
|
Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91
Day 56: Ointment treated vs.vehicle treated plaque
|
60.0 percentage of participants
|
|
Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91
Day 56: Vehicle treated vs.ointment treated plaque
|
16.7 percentage of participants
|
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Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91
Day 70: Ointment treated vs.vehicle treated plaque
|
56.7 percentage of participants
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Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91
Day 70: Vehicle treated vs.ointment treated plaque
|
23.3 percentage of participants
|
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Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91
Day 91: Vehicle treated vs.ointment treated plaque
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30.0 percentage of participants
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Adverse Events
AN2728 5% Ointment + Ointment Vehicle
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AN2728 5% Ointment + Ointment Vehicle
n=29 participants at risk
AN2728 5 % ointment and ointment vehicle were applied to 2 comparable and anatomically distinct treatment-targeted plaques, respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
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|---|---|
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Skin and subcutaneous tissue disorders
Drug eruption
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3.4%
1/29
Same event may appear as both an Adverse Event (AE) and Serious Adverse Event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study. Safety population included all participants who used the study medication and provided a safety evaluation.
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Other adverse events
| Measure |
AN2728 5% Ointment + Ointment Vehicle
n=29 participants at risk
AN2728 5 % ointment and ointment vehicle were applied to 2 comparable and anatomically distinct treatment-targeted plaques, respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
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|---|---|
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Infections and infestations
Pharyngitis
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6.9%
2/29
Same event may appear as both an Adverse Event (AE) and Serious Adverse Event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study. Safety population included all participants who used the study medication and provided a safety evaluation.
|
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Skin and subcutaneous tissue disorders
Dermatitis contact
|
24.1%
7/29
Same event may appear as both an Adverse Event (AE) and Serious Adverse Event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study. Safety population included all participants who used the study medication and provided a safety evaluation.
|
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Skin and subcutaneous tissue disorders
Scab
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3.4%
1/29
Same event may appear as both an Adverse Event (AE) and Serious Adverse Event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study. Safety population included all participants who used the study medication and provided a safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
3.4%
1/29
Same event may appear as both an Adverse Event (AE) and Serious Adverse Event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study. Safety population included all participants who used the study medication and provided a safety evaluation.
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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