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AN2728 Topical Ointment to Treat Mild-to-Moderate Plaque-Type Psoriasis

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ClinicalTrials.gov Identifier: NCT01300052
Recruitment Status : Completed
First Posted : February 21, 2011
Results First Posted : March 7, 2017
Last Update Posted : April 17, 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 ointment, 2%
Drug: Ointment Vehicle
Enrollment 68
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AN2728 Ointment, 2% AN2728 Ointment, Vehicle
Hide Arm/Group Description AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
Period Title: Overall Study
Started 46 22
Completed 40 19
Not Completed 6 3
Reason Not Completed
Adverse Event             3             0
Withdrawal by Subject             2             2
Protocol Violation             1             1
Arm/Group Title AN2728 Ointment, 2% AN2728 Ointment, Vehicle Total
Hide Arm/Group Description AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator. AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator. Total of all reporting groups
Overall Number of Baseline Participants 46 22 68
Hide Baseline Analysis Population Description
The Intent-to-Treat (ITT) population included all randomized participants who received the study medication.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 22 participants 68 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
41
  89.1%
20
  90.9%
61
  89.7%
>=65 years
5
  10.9%
2
   9.1%
7
  10.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 22 participants 68 participants
Female
12
  26.1%
9
  40.9%
21
  30.9%
Male
34
  73.9%
13
  59.1%
47
  69.1%
1.Primary Outcome
Title Percentage of Participants Who Achieved Success in Physician's Global Assessment (PGA) of Disease Severity at Day 84
Hide Description PGA assessed severity of overall disease activity in participants. It was performed using a 6-point scale graded from 0 - 5, in which 0 = clear (no plaque elevation above normal skin level), 1 = almost clear (essentially flat with possible trace elevation), 2 = mild (slight but definite elevation of plaque above normal skin level), 3 = moderate (moderate elevation with rounded or sloped edges to plaque), 4 = severe (marked elevation with hard, sharp edges to plaque), 5 = very severe (very marked elevation with very hard, sharp edges to plaque). The success in PGA of disease severity was defined as a PGA score of ‘0 = clear’ or ‘1 = almost clear’, with at least 2-grade improvement in PGA from Baseline to Day 84.
Time Frame Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received the study medication. Missing data was imputed using last observation carried forward (LOCF) method.
Arm/Group Title AN2728 Ointment, 2% AN2728 Ointment, Vehicle
Hide Arm/Group Description:
AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
Overall Number of Participants Analyzed 46 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
17.4
(6.4 to 28.3)
13.6
(0.0 to 28.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AN2728 Ointment, 2%, AN2728 Ointment, Vehicle
Comments Difference in percentage was calculated as values of AN2728 Ointment, 2% group minus values of AN2728 Ointment, Vehicle group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 3.8
Confidence Interval (2-Sided) 95%
-14.3 to 21.8
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Who Achieved Success in Physician's Global Assessment (PGA) of Disease Severity at Days 14, 28, 42, 56, and 70
Hide Description PGA assessed severity of overall disease activity in participants. It was performed using a 6-point scale graded from 0 - 5, in which 0 = clear (no plaque elevation above normal skin level), 1 = almost clear (essentially flat with possible trace elevation), 2 = mild (slight but definite elevation of plaque above normal skin level), 3 = moderate (moderate elevation with rounded or sloped edges to plaque), 4 = severe (marked elevation with hard, sharp edges to plaque), 5 = very severe (very marked elevation with very hard, sharp edges to plaque). The success in PGA of disease severity was defined as a PGA score of ‘0 = clear’ or ‘1 = almost clear’, with at least 2-grade improvement in PGA from Baseline to Day 14, 28, 42, 56 and 70.
Time Frame Day 14, Day 28, Day 42, Day 56, Day 70
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received the study medication.
Arm/Group Title AN2728 Ointment, 2% AN2728 Ointment, Vehicle
Hide Arm/Group Description:
AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
Overall Number of Participants Analyzed 46 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Day 14
2.2
(0.0 to 6.4)
0 [1] 
(NA to NA)
Day 28
8.7
(0.6 to 16.8)
4.5
(0.0 to 13.2)
Day 42
26.1
(13.4 to 38.8)
18.2
(2.1 to 34.3)
Day 56
21.7
(9.8 to 33.7)
13.6
(0.0 to 28.0)
Day 70
17.4
(6.4 to 28.3)
13.6
(0.0 to 28.0)
[1]
95% Confidence Interval was not evaluable as there were no participants who achieved success in PGA at the specified time point
3.Secondary Outcome
Title Change From Baseline in Percentage of Body Surface Area (%BSA) Involved With Psoriasis at Day 84
Hide Description Percentage of the total body surface area (BSA) involved with psoriasis was measured. Change from Baseline (Day 1) in percentage of BSA at Day 84 was reported.
Time Frame Baseline (Day 1), Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received the study medication. Missing data was imputed using LOCF method.
Arm/Group Title AN2728 Ointment, 2% AN2728 Ointment, Vehicle
Hide Arm/Group Description:
AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
Overall Number of Participants Analyzed 46 22
Mean (Standard Deviation)
Unit of Measure: percentage of body surface area
-2.1  (3.20) -1.4  (3.22)
4.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 84 that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAE and non-SAE.
Time Frame Baseline (Day 1) up to Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants with confirmed usage of the study medication.
Arm/Group Title AN2728 Ointment, 2% AN2728 Ointment, Vehicle
Hide Arm/Group Description:
AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
Overall Number of Participants Analyzed 46 22
Measure Type: Number
Unit of Measure: participants
AEs 23 12
SAEs 0 2
5.Secondary Outcome
Title Number of Treatment-Emergent Adverse Events (TEAEs) by Severity
Hide Description An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were classified according to the severity in 3 categories a) mild =AEs does not interfere with participant’s usual function b) moderate =AEs interfered to some extent with participant’s usual function c) severe =AEs interfered significantly with participant’s usual function and required systemic drug therapy. Treatment-emergent were events between first dose of study drug and up to Day 84 that were absent before treatment or that worsened relative to pretreatment state. In this outcome measure, number of mild, moderate and severe TEAEs were reported.
Time Frame Baseline (Day 1) up to Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants with confirmed usage of the study medication.
Arm/Group Title AN2728 Ointment, 2% AN2728 Ointment, Vehicle
Hide Arm/Group Description:
AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
Overall Number of Participants Analyzed 46 22
Measure Type: Number
Unit of Measure: adverse events
Mild 14 11
Moderate 25 5
Severe 5 5
6.Secondary Outcome
Title Number of Participants With Local Tolerability Symptoms: Burning/Stinging
Hide Description Local tolerability in participants was evaluated in terms of presence and absence of burning/stinging symptom and its severity in the areas of body where medication was applied. Burning/stinging symptoms were graded on a 4-point scale of 0 - 3 where 0 =none (no stinging/ burning), 1 =mild (slight warm, tingling sensation), 2 = moderate (definite warm; tingling/stinging sensation), 3 = severe (hot, tingling/stinging sensation that caused definite discomfort). Higher scores=Severe symptoms. In this outcome measure, number of participants with none, mild, moderate and severe burning/stinging symptoms were reported.
Time Frame Baseline (Day 1) up to Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants with confirmed usage of the study medication. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Arm/Group Title AN2728 Ointment, 2% AN2728 Ointment, Vehicle
Hide Arm/Group Description:
AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
Overall Number of Participants Analyzed 40 19
Measure Type: Number
Unit of Measure: participants
None 31 18
Mild 5 1
Moderate 4 0
Severe 0 0
7.Secondary Outcome
Title Number of Participants With Local Tolerability Symptoms: Pruritus
Hide Description Local tolerability was evaluated in participants in terms of presence and absence of pruritus symptom and its severity in the areas of body where medication was applied. Pruritus symptoms were graded on a 4-point scale of 0 - 3 where 0 =none (no pruritus), 1 =mild (occasional, slight itching/scratching), 2 = moderate (constant or intermittent itching/scratching which was not disturbing sleep), 3 = severe (bothersome itching/scratching which was disturbing sleep). Higher scores=Severe symptoms. In this outcome measure, number of participants with none, mild, moderate and severe pruritus symptoms were reported.
Time Frame Baseline (Day 1) up to Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants with confirmed usage of the study medication. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Arm/Group Title AN2728 Ointment, 2% AN2728 Ointment, Vehicle
Hide Arm/Group Description:
AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
Overall Number of Participants Analyzed 40 19
Measure Type: Number
Unit of Measure: participants
None 23 13
Mild 8 6
Moderate 5 0
Severe 4 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AN2728 Ointment, 2% AN2728 Ointment, Vehicle
Hide Arm/Group Description AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator. AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
All-Cause Mortality
AN2728 Ointment, 2% AN2728 Ointment, Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
AN2728 Ointment, 2% AN2728 Ointment, Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   0/46 (0.00%)   2/22 (9.09%) 
Infections and infestations     
Cholecystitis infective * 1  0/46 (0.00%)  1/22 (4.55%) 
Nervous system disorders     
Convulsion * 1  0/46 (0.00%)  1/22 (4.55%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
AN2728 Ointment, 2% AN2728 Ointment, Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   23/46 (50.00%)   12/22 (54.55%) 
Gastrointestinal disorders     
Gastritis * 1  1/46 (2.17%)  0/22 (0.00%) 
General disorders     
Application site pain * 1  1/46 (2.17%)  0/22 (0.00%) 
Application site pruritus * 1  1/46 (2.17%)  0/22 (0.00%) 
Application site rash * 1  1/46 (2.17%)  0/22 (0.00%) 
Medical device pain * 1  1/46 (2.17%)  0/22 (0.00%) 
Oedema peripheral * 1  2/46 (4.35%)  1/22 (4.55%) 
Hepatobiliary disorders     
Cholecystitis * 1  0/46 (0.00%)  1/22 (4.55%) 
Cholelithiasis * 1  0/46 (0.00%)  1/22 (4.55%) 
Immune system disorders     
Hypersensitivity * 1  1/46 (2.17%)  0/22 (0.00%) 
Seasonal allergy * 1  1/46 (2.17%)  0/22 (0.00%) 
Infections and infestations     
Gastroenteritis viral * 1  0/46 (0.00%)  1/22 (4.55%) 
Herpes zoster * 1  0/46 (0.00%)  1/22 (4.55%) 
Influenza * 1  0/46 (0.00%)  1/22 (4.55%) 
Nasopharyngitis * 1  4/46 (8.70%)  1/22 (4.55%) 
Sinusitis * 1  1/46 (2.17%)  0/22 (0.00%) 
Tooth abscess * 1  1/46 (2.17%)  0/22 (0.00%) 
Upper respiratory tract infection * 1  0/46 (0.00%)  2/22 (9.09%) 
Urinary tract infection * 1  1/46 (2.17%)  0/22 (0.00%) 
Injury, poisoning and procedural complications     
Arthropod bite * 1  0/46 (0.00%)  1/22 (4.55%) 
Joint dislocation * 1  1/46 (2.17%)  0/22 (0.00%) 
Procedural pain * 1  1/46 (2.17%)  0/22 (0.00%) 
Skeletal injury * 1  0/46 (0.00%)  1/22 (4.55%) 
Investigations     
Alanine aminotransferase increased * 1  1/46 (2.17%)  0/22 (0.00%) 
Metabolism and nutrition disorders     
Diabetes mellitus * 1  0/46 (0.00%)  1/22 (4.55%) 
Hypercholesterolaemia * 1  0/46 (0.00%)  1/22 (4.55%) 
Type 2 diabetes mellitus * 1  0/46 (0.00%)  1/22 (4.55%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/46 (2.17%)  0/22 (0.00%) 
Joint swelling * 1  1/46 (2.17%)  0/22 (0.00%) 
Musculoskeletal pain * 1  1/46 (2.17%)  0/22 (0.00%) 
Plantar fasciitis * 1  1/46 (2.17%)  0/22 (0.00%) 
Tendonitis * 1  1/46 (2.17%)  0/22 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Brain cancer metastatic * 1  0/46 (0.00%)  1/22 (4.55%) 
Lung neoplasm malignant * 1  0/46 (0.00%)  1/22 (4.55%) 
Seborrhoeic keratosis * 1  1/46 (2.17%)  0/22 (0.00%) 
Nervous system disorders     
Burning sensation * 1  1/46 (2.17%)  0/22 (0.00%) 
Dizziness * 1  1/46 (2.17%)  0/22 (0.00%) 
Renal and urinary disorders     
Nephrolithiasis * 1  1/46 (2.17%)  0/22 (0.00%) 
Urinary tract pain * 1  1/46 (2.17%)  0/22 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  0/46 (0.00%)  1/22 (4.55%) 
Nasal congestion * 1  0/46 (0.00%)  1/22 (4.55%) 
Oropharyngeal pain * 1  0/46 (0.00%)  1/22 (4.55%) 
Skin and subcutaneous tissue disorders     
Blister * 1  1/46 (2.17%)  0/22 (0.00%) 
Dermatitis contact * 1  4/46 (8.70%)  0/22 (0.00%) 
Erythema * 1  2/46 (4.35%)  0/22 (0.00%) 
Guttate psoriasis * 1  1/46 (2.17%)  0/22 (0.00%) 
Pruritus * 1  2/46 (4.35%)  0/22 (0.00%) 
Psoriasis * 1  1/46 (2.17%)  0/22 (0.00%) 
Rash * 1  1/46 (2.17%)  0/22 (0.00%) 
Vascular disorders     
Hypertension * 1  1/46 (2.17%)  0/22 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
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
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01300052     History of Changes
Other Study ID Numbers: AN2728-PSR-204
C3291017 ( Other Identifier: Alias Study Number )
First Submitted: February 17, 2011
First Posted: February 21, 2011
Results First Submitted: January 12, 2017
Results First Posted: March 7, 2017
Last Update Posted: April 17, 2017