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Safety and Efficacy Study of a Novel Ointment to Treat Plaque Type Psoriasis (AN2728PSR203)

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ClinicalTrials.gov Identifier: NCT01029405
Recruitment Status : Completed
First Posted : December 10, 2009
Results First Posted : March 7, 2017
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Psoriasis
Interventions Drug: AN2728
Drug: Placebo
Enrollment 145
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AN2728 Ointment B 0.5 Percent + Ointment B Vehicle, Once Daily AN2728 Ointment B 0.5 Percent +Ointment B Vehicle, Twice Daily AN2728 Ointment B 2 Percent + Ointment B Vehicle, Once Daily AN2728 Ointment B 2 Percent + Ointment B Vehicle, Twice Daily
Hide Arm/Group Description AN2728 ointment B 0.5 percent (%) and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator. AN2728 ointment B 0.5 percent and ointment B vehicle was 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. AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator. AN2728 ointment B 2 percent and ointment B vehicle was 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 36 37 35 37
Completed 34 34 31 32
Not Completed 2 3 4 5
Reason Not Completed
Withdrawal by Subject             0             1             2             0
Protocol Violation             0             0             0             1
Adverse Event             0             0             1             1
Lost to Follow-up             2             1             1             2
Other             0             1             0             1
Arm/Group Title AN2728 Ointment B 0.5 Percent + Ointment B Vehicle, Once Daily AN2728 Ointment B 0.5 Percent +Ointment B Vehicle, Twice Daily AN2728 Ointment B 2 Percent + Ointment B Vehicle, Once Daily AN2728 Ointment B 2 Percent + Ointment B Vehicle, Twice Daily Total
Hide Arm/Group Description AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator. AN2728 ointment B 0.5 percent and ointment B vehicle was 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. AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator. AN2728 ointment B 2 percent and ointment B vehicle was 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. Total of all reporting groups
Overall Number of Baseline Participants 36 37 35 37 145
Hide Baseline Analysis Population Description
Intent-to-treat population included all randomized participants who received the study medication.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 37 participants 35 participants 37 participants 145 participants
<=18 years
0
   0.0%
1
   2.7%
0
   0.0%
0
   0.0%
1
   0.7%
Between 18 and 65 years
36
 100.0%
31
  83.8%
34
  97.1%
33
  89.2%
134
  92.4%
>=65 years
0
   0.0%
5
  13.5%
1
   2.9%
4
  10.8%
10
   6.9%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 37 participants 35 participants 37 participants 145 participants
Female
6
  16.7%
4
  10.8%
4
  11.4%
4
  10.8%
18
  12.4%
Male
30
  83.3%
33
  89.2%
31
  88.6%
33
  89.2%
127
  87.6%
1.Primary Outcome
Title Percentage of Participants With Greater Decrease In Overall Target Plaque Severity Score (OTPSS): Ointment (2% Twice Daily), Vehicle
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 indicates more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS in ointment (2% twice daily) treated plaque versus (vs.) vehicle treated plaque and percentage of participants with reduced OTPSS in vehicle treated plaque versus ointment (2% twice daily) treated plaque respectively at Day 42 are reported.
Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population included all randomized participants who received study medication.
Arm/Group Title AN2728 Ointment B 2 Percent + Ointment B Vehicle, Twice Daily
Hide Arm/Group Description:
AN2728 ointment B 2 percent and ointment B vehicle was 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 37
Measure Type: Number
Unit of Measure: percenatge of participants
Ointment Treated Plaque vs. Vehicle Treated Plaque 54.1
Vehicle Treated Plaque vs. Ointment Treated Plaque 2.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AN2728 Ointment B 2 Percent + Ointment B Vehicle, Twice Daily
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method 2-sided sign test
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Greater Decrease In OTPSS: Ointment (0.5 % Once Daily, 0.5% Twice Daily and 2% Once Daily), Vehicle
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 scores indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS in ointment (0.5 % once daily, 0.5% twice daily and 2% once daily) treated plaque versus vehicle treated plaque and percentage of participants with reduced OTPSS in vehicle treated plaque versus ointment (0.5 % once daily, 0.5% twice daily and 2% once daily) treated plaque respectively at Day 42 are reported.
Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population included all randomized participants who received the study medication.
Arm/Group Title AN2728 Ointment B 0.5 Percent + Ointment B Vehicle, Once Daily AN2728 Ointment B 0.5 Percent +Ointment B Vehicle, Twice Daily AN2728 Ointment B 2 Percent + Ointment B Vehicle, Once Daily
Hide Arm/Group Description:
AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
AN2728 ointment B 0.5 percent and ointment B vehicle was 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.
AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
Overall Number of Participants Analyzed 36 37 35
Measure Type: Number
Unit of Measure: percenatge of participants
Ointment Treated Plaque vs. Vehicle Treated Plaque 30.6 43.2 40.0
Vehicle Treated Plaque vs. Ointment Treated Plaque 11.1 8.1 0.0
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events were assessed in safety population which included participants who received study medication and provided a safety evaluation.
 
Arm/Group Title AN2728 Ointment B 0.5 Percent + Ointment B Vehicle, Once Daily AN2728 Ointment B 0.5 Percent +Ointment B Vehicle, Twice Daily AN2728 Ointment B 2 Percent + Ointment B Vehicle, Once Daily AN2728 Ointment B 2 Percent + Ointment B Vehicle, Twice Daily
Hide Arm/Group Description AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator. AN2728 ointment B 0.5 percent and ointment B vehicle was 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. AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator. AN2728 ointment B 2 percent and ointment B vehicle was 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 Ointment B 0.5 Percent + Ointment B Vehicle, Once Daily AN2728 Ointment B 0.5 Percent +Ointment B Vehicle, Twice Daily AN2728 Ointment B 2 Percent + Ointment B Vehicle, Once Daily AN2728 Ointment B 2 Percent + Ointment B Vehicle, Twice Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
AN2728 Ointment B 0.5 Percent + Ointment B Vehicle, Once Daily AN2728 Ointment B 0.5 Percent +Ointment B Vehicle, Twice Daily AN2728 Ointment B 2 Percent + Ointment B Vehicle, Once Daily AN2728 Ointment B 2 Percent + Ointment B Vehicle, Twice Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/37 (0.00%)   0/34 (0.00%)   0/37 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
AN2728 Ointment B 0.5 Percent + Ointment B Vehicle, Once Daily AN2728 Ointment B 0.5 Percent +Ointment B Vehicle, Twice Daily AN2728 Ointment B 2 Percent + Ointment B Vehicle, Once Daily AN2728 Ointment B 2 Percent + Ointment B Vehicle, Twice Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/36 (25.00%)   14/37 (37.84%)   12/34 (35.29%)   16/37 (43.24%) 
Blood and lymphatic system disorders         
Anaemia * 1  0/36 (0.00%)  0/37 (0.00%)  0/34 (0.00%)  1/37 (2.70%) 
Anaemia megaloblastic * 1  0/36 (0.00%)  1/37 (2.70%)  0/34 (0.00%)  0/37 (0.00%) 
Ear and labyrinth disorders         
Ear pain * 1  0/36 (0.00%)  1/37 (2.70%)  0/34 (0.00%)  0/37 (0.00%) 
Eye disorders         
Conjunctivitis * 1  1/36 (2.78%)  0/37 (0.00%)  0/34 (0.00%)  0/37 (0.00%) 
Gastrointestinal disorders         
Colitis * 1  0/36 (0.00%)  1/37 (2.70%)  0/34 (0.00%)  0/37 (0.00%) 
Diarrhoea * 1  0/36 (0.00%)  1/37 (2.70%)  0/34 (0.00%)  0/37 (0.00%) 
General disorders         
Pain * 1  0/36 (0.00%)  1/37 (2.70%)  0/34 (0.00%)  0/37 (0.00%) 
Swelling * 1  0/36 (0.00%)  1/37 (2.70%)  0/34 (0.00%)  0/37 (0.00%) 
Hepatobiliary disorders         
Cholestasis * 1  0/36 (0.00%)  0/37 (0.00%)  1/34 (2.94%)  0/37 (0.00%) 
Infections and infestations         
Bronchitis * 1  0/36 (0.00%)  1/37 (2.70%)  0/34 (0.00%)  0/37 (0.00%) 
Ear infection * 1  0/36 (0.00%)  1/37 (2.70%)  0/34 (0.00%)  0/37 (0.00%) 
Furuncle * 1  1/36 (2.78%)  0/37 (0.00%)  0/34 (0.00%)  0/37 (0.00%) 
Gastroenteritis * 1  0/36 (0.00%)  0/37 (0.00%)  1/34 (2.94%)  0/37 (0.00%) 
Influenza * 1  3/36 (8.33%)  3/37 (8.11%)  0/34 (0.00%)  1/37 (2.70%) 
Otitis media acute * 1  1/36 (2.78%)  0/37 (0.00%)  0/34 (0.00%)  0/37 (0.00%) 
Pharyngitis * 1  2/36 (5.56%)  1/37 (2.70%)  1/34 (2.94%)  1/37 (2.70%) 
Pharyngotonsillitis * 1  1/36 (2.78%)  0/37 (0.00%)  2/34 (5.88%)  0/37 (0.00%) 
Pneumonia * 1  0/36 (0.00%)  0/37 (0.00%)  1/34 (2.94%)  0/37 (0.00%) 
Injury, poisoning and procedural complications         
Ankle fracture * 1  0/36 (0.00%)  0/37 (0.00%)  1/34 (2.94%)  0/37 (0.00%) 
Arthropod bite * 1  0/36 (0.00%)  0/37 (0.00%)  0/34 (0.00%)  1/37 (2.70%) 
Bone fissure * 1  0/36 (0.00%)  0/37 (0.00%)  1/34 (2.94%)  0/37 (0.00%) 
Clavicle fracture * 1  0/36 (0.00%)  0/37 (0.00%)  1/34 (2.94%)  0/37 (0.00%) 
Excoriation * 1  1/36 (2.78%)  0/37 (0.00%)  0/34 (0.00%)  1/37 (2.70%) 
Joint sprain * 1  1/36 (2.78%)  0/37 (0.00%)  0/34 (0.00%)  0/37 (0.00%) 
Penis injury * 1 [1]  0/30 (0.00%)  0/33 (0.00%)  1/30 (3.33%)  0/33 (0.00%) 
Investigations         
Transaminases increased * 1  0/36 (0.00%)  0/37 (0.00%)  0/34 (0.00%)  1/37 (2.70%) 
Metabolism and nutrition disorders         
Dyslipidaemia * 1  0/36 (0.00%)  1/37 (2.70%)  0/34 (0.00%)  1/37 (2.70%) 
Hypertriglyceridaemia * 1  0/36 (0.00%)  0/37 (0.00%)  1/34 (2.94%)  0/37 (0.00%) 
Hyperuricaemia * 1  0/36 (0.00%)  0/37 (0.00%)  1/34 (2.94%)  0/37 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  0/36 (0.00%)  0/37 (0.00%)  0/34 (0.00%)  1/37 (2.70%) 
Back pain * 1  1/36 (2.78%)  0/37 (0.00%)  0/34 (0.00%)  1/37 (2.70%) 
Myalgia * 1  0/36 (0.00%)  1/37 (2.70%)  0/34 (0.00%)  0/37 (0.00%) 
Pain in extremity * 1  1/36 (2.78%)  0/37 (0.00%)  1/34 (2.94%)  0/37 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Oropharyngeal pain * 1  0/36 (0.00%)  2/37 (5.41%)  0/34 (0.00%)  0/37 (0.00%) 
Skin and subcutaneous tissue disorders         
Dermatitis contact * 1  1/36 (2.78%)  0/37 (0.00%)  1/34 (2.94%)  3/37 (8.11%) 
Pruritus * 1  1/36 (2.78%)  2/37 (5.41%)  1/34 (2.94%)  6/37 (16.22%) 
Pruritus generalised * 1  0/36 (0.00%)  0/37 (0.00%)  1/34 (2.94%)  0/37 (0.00%) 
Psoriasis * 1  1/36 (2.78%)  0/37 (0.00%)  1/34 (2.94%)  0/37 (0.00%) 
Vascular disorders         
Hypertension * 1  0/36 (0.00%)  1/37 (2.70%)  1/34 (2.94%)  1/37 (2.70%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.1
[1]
This adverse event was gender specific.
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.
Restriction Description: 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: NCT01029405     History of Changes
Other Study ID Numbers: AN2728-PSR-203
C3291016 ( Other Identifier: Pfizer )
First Submitted: December 7, 2009
First Posted: December 10, 2009
Results First Submitted: January 12, 2017
Results First Posted: March 7, 2017
Last Update Posted: March 7, 2017