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Trial record 2 of 762 for:    plaque | "Psoriasis"

Safety and Efficacy Study of A Novel Ointment to Treat Plaque Type Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00755196
Recruitment Status : Completed
First Posted : September 18, 2008
Results First Posted : March 6, 2017
Last Update Posted : March 6, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Psoriasis
Interventions Drug: AN2728
Drug: Ointment vehicle
Enrollment 30

Recruitment Details  
Pre-assignment Details  
Arm/Group Title AN2728 5 Percent (%) Ointment + Ointment Vehicle
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 30
Completed 28
Not Completed 2
Reason Not Completed
Lost to Follow-up             1
Lack of Efficiency             1
Arm/Group Title AN2728 5% Ointment + Ointment Vehicle
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population included all randomized participants who received the study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
48.4  (8.63)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
0
   0.0%
Male
30
 100.0%
1.Primary Outcome
Title Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) at Day 84
Hide Description 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’.
Time Frame Day 84
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received the study medication.
Arm/Group Title AN2728 5% Ointment + Ointment Vehicle
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: percentage of participants
Ointment treated plaque vs. vehicle treated plaque 53.3
Vehicle treated plaque vs. ointment treated plaque 30.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AN2728 5% Ointment + Ointment Vehicle
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.23
Comments [Not Specified]
Method 2-sided sign test
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91
Hide Description 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’.
Time Frame Day 7, 14, 28, 42, 56, 70, 91
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received the study medication.
Arm/Group Title AN2728 5% Ointment + Ointment Vehicle
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: percentage of participants
Day 7: Ointment treated vs.vehicle treated plaque 10.0
Day 7: Vehicle treated vs.ointment treated plaque 10.0
Day 14: Ointment treated vs.vehicle treated plaque 43.3
Day 14: Vehicle treated vs.ointment treated plaque 10.0
Day 28: Ointment treated vs.vehicle treated plaque 60.0
Day 28: Vehicle treated vs.ointment treated plaque 3.3
Day 42: Ointment treated vs.vehicle treated plaque 60.0
Day 42: Vehicle treated vs.ointment treated plaque 6.7
Day 56: Ointment treated vs.vehicle treated plaque 60.0
Day 56: Vehicle treated vs.ointment treated plaque 16.7
Day 70: Ointment treated vs.vehicle treated plaque 56.7
Day 70: Vehicle treated vs.ointment treated plaque 23.3
Day 91: Ointment treated vs.vehicle treated plaque 40.0
Day 91: Vehicle treated vs.ointment treated plaque 30.0
Time Frame [Not Specified]
Adverse Event Reporting Description 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.
 
Arm/Group Title AN2728 5% Ointment + Ointment Vehicle
Hide Arm/Group Description 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.
All-Cause Mortality
AN2728 5% Ointment + Ointment Vehicle
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
AN2728 5% Ointment + Ointment Vehicle
Affected / at Risk (%)
Total   1/29 (3.45%) 
Skin and subcutaneous tissue disorders   
Drug eruption * 1  1/29 (3.45%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
AN2728 5% Ointment + Ointment Vehicle
Affected / at Risk (%)
Total   8/29 (27.59%) 
Infections and infestations   
Pharyngitis * 1  2/29 (6.90%) 
Skin and subcutaneous tissue disorders   
Dermatitis contact * 1  7/29 (24.14%) 
Scab * 1  1/29 (3.45%) 
Drug eruption * 2  1/29 (3.45%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.1)
2
Term from vocabulary, MedDRA 11.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer,Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00755196     History of Changes
Other Study ID Numbers: AN2728-PSR-202
C3291015 ( Other Identifier: Pfizer )
First Submitted: September 17, 2008
First Posted: September 18, 2008
Results First Submitted: January 12, 2017
Results First Posted: March 6, 2017
Last Update Posted: March 6, 2017