Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 568 for:    applied AND irritation

Study in Elderly Alzheimer's Patients to Assess Skin Tolerability, Irritation With 3, 7-Day Applications of DTP-System (DTP-System)

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: NCT00916383
Recruitment Status : Completed
First Posted : June 9, 2009
Results First Posted : April 22, 2016
Last Update Posted : April 22, 2016
Sponsor:
Information provided by (Responsible Party):
Teikoku Pharma USA, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Irritation/Irritant
Interventions Drug: 350 mg Donepezil Transdermal Patch
Drug: Placebo Patch
Enrollment 49
Recruitment Details The study was conducted at 7 clinical sites during May and June 2009. Patients received 1 placebo patch and 1 Donepezil Transdermal Patch, each applied to opposite sides of the body. The 7-day patches were applied to 1 of 3 consecutive body locations according to 1 of 6 treatment sequences for a total treatment period of 21 days.
Pre-assignment Details Patients diagnosed with Alzheimer's disease who were on a stable course of oral Aricept (10 mg/day) were randomized into the study. Patients discontinued oral Aricept on Day -1 and resumed their original established dose following removal of the last patch.
Arm/Group Title All Participants
Hide Arm/Group Description

Patients were randomized to receive the active patch on the left or right side of the body, and the matching placebo patch on the same location on the opposite side of the body, and assigned to one of two sets (left and right of the body for placement of the active patch) of the following 6 treatment sequences. The treatment sequence was repeated for the opposite side of the body for a total of 12 treatment sequences. The 7-day patches were applied to one of 3 consecutive body locations, for a total exposure period of 21 days.

  1. Upper Back, Upper Arm, Side of Torso
  2. Upper Arm, Side of Torso, Upper Back
  3. Side of Torso, Upper Back, Upper Arm
  4. Upper Back, Side of Torso, Upper Arm
  5. Upper Arm, Upper Back, Side of Torso
  6. Side of Torso, Upper Arm, Upper Back

Skin irritation scoring was obtained immediately upon removal of the patch and at 1, 24, and 48 hours after removal.

Period Title: Overall Study
Started 49
Completed 46
Not Completed 3
Reason Not Completed
Adverse Event             1
Death             1
Protocol Violation             1
Arm/Group Title All Participants
Hide Arm/Group Description All patients received the same study treatment, consisting of 1 placebo patch and 1 Donepezil Transdermal Patch, and all patches were applied to the same body locations according to 1 of 6 treatment sequences. The active patch was applied to either the right or the left side of the body according to the randomization schedule. The treatment sequence was repeated for the opposite side of the body for a total of 12 treatment sequences. The 7-day patches were applied to one of 3 body locations (upper arm, upper back, side of torso) for a total treatment period of 21 days.
Overall Number of Baseline Participants 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
All Participants Number Analyzed 49 participants
79.5  (6.47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants
Female
29
  59.2%
Male
20
  40.8%
1.Primary Outcome
Title Skin Irritation (Erythema and Edema)
Hide Description Erythema and edema were used to determine skin irritation using a modified Draize scale. Score 0 = no erythema/edema; Score 1 = very slight erythema/edema; Score 2 = well-defined erythema/slight edema; Score 3 = moderate to severe erythema/edema; Score 4 = severe erythema/edema.
Time Frame Immediately after patch removal
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received patches are included in the analysis. Note: The represented data are based on N = 48 for patients who received the placebo patch and the DTP-system on the Upper Back, N = 46 for patients who received the placebo patch on the side of torso, and N = 47 for patients who received the DTP-system on the side of torso.
Arm/Group Title Upper Back Upper Arm Side of Torso
Hide Arm/Group Description:
DTP-system and placebo patch applied to opposite sides of the upper back.
DTP-system and placebo patch applied to the upper part of opposite arms.
DTP-system and placebo patch applied to opposite sides of torso.
Overall Number of Participants Analyzed 48 48 47
Mean (Standard Deviation)
Unit of Measure: units on a scale
Erythema, Placebo 0.9  (0.85) 0.7  (0.76) 1.1  (0.89)
Erythema, DTP-System 1.0  (0.75) 0.8  (0.75) 1.0  (0.85)
Edema, Placebo 0.6  (0.82) 0.6  (0.68) 0.7  (0.71)
Edema, DTP-System 0.6  (0.76) 0.5  (0.68) 0.7  (0.73)
2.Primary Outcome
Title Skin Irritation (Erythema)
Hide Description Erythema was used to determine skin irritation using a modified Draize scale. Score 0 = no erythema; Score 1 = very slight erythema; Score 2 = well-defined erythema; Score 3 = moderate to severe erythema; Score 4 = severe erythema.
Time Frame 1, 24, and 48 hours after patch removal (Days 8-10; Days 15-17; Days 22-24)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received patches are included in the analysis.
Arm/Group Title Upper Back Upper Arm Side of Torso
Hide Arm/Group Description:
DTP-system and placebo patch applied to opposite sides of the upper back.
DTP-system and placebo patch applied to the upper part of opposite arms.
DTP-system and placebo patch applied to opposite sides of torso.
Overall Number of Participants Analyzed 49 48 47
Mean (Standard Deviation)
Unit of Measure: units on a scale
1 hour after patch removal, Placebo 0.8  (0.88) 0.6  (0.65) 0.8  (0.82)
1 hour after patch removal, DTP-system 0.9  (0.73) 0.6  (0.64) 0.7  (0.74)
24 hours after patch removal, Placebo 0.6  (0.80) 0.3  (0.52) 0.7  (0.71)
24 hours after patch removal, DTP-system 0.4  (0.62) 0.4  (0.57) 0.4  (0.62)
48 hours after patch removal, Placebo 0.3  (0.54) 0.2  (0.46) 0.4  (0.65)
48 hours after patch removal, DTP-system 0.2  (0.43) 0.2  (0.43) 0.3  (0.59)
3.Primary Outcome
Title Skin Irritation (Edema)
Hide Description Edema was used to determine skin irritation using a modified Draize scale. Score 0 = no edema; Score 1 = very slight edema; Score 2 = slight edema; Score 3 = moderate to severe edema; Score 4 = severe edema.
Time Frame 1, 24, and 48 hours after patch removal (Days 8-10; Days 15-17; Days 22-24)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received patches are included in the analysis.
Arm/Group Title Upper Back Upper Arm Side of Torso
Hide Arm/Group Description:
DTP-system and placebo patch applied to opposite sides of the upper back.
DTP-system and placebo patch applied to the upper part of opposite arms.
DTP-system and placebo patch applied to opposite sides of torso.
Overall Number of Participants Analyzed 49 48 47
Mean (Standard Deviation)
Unit of Measure: units on a scale
1 hour after patch removal, Placebo 0.6  (0.76) 0.6  (0.68) 0.6  (0.71)
1 hour after patch removal, DTP-system 0.6  (0.73) 0.4  (0.57) 0.6  (0.71)
24 hours after patch removal, Placebo 0.1  (0.41) 0.2  (0.38) 0.2  (0.47)
24 hours after patch removal, DTP-system 0.1  (0.33) 0.1  (0.34) 0.1  (0.40)
48 hours after patch removal, Placebo 0.0  (0.14) 0.0  (0.15) 0.1  (0.25)
48 hours after patch removal, DTP-system 0.0  (0.14) 0.0  (0.15) 0.0  (0.29)
4.Primary Outcome
Title Skin Irritation (Papules and Vesicles)
Hide Description Papules and vesicles were assessed according to the following scoring criteria: Score 0 = no evidence of papules or vesicles; Score 1 = few papules or vesicles (< 10) observed on the skin site; Score 2 = more papules or vesicles (≥ 10) observed on < 50 % of skin site, diffuse or few clusters; Score 3 = many papules or vesicles observed on ≥ 50% of skin site, diffuse or few clusters; Score 4 = many papules or vesicles observed on > 50% of skin site, with multiple (> 3) clusters.
Time Frame Immediately after patch removal
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received patches are included in the analysis. Note: The represented data are based on N = 48 for patients who received the placebo patch and the DTP-system on the Upper Back, N = 46 for patients who received the placebo patch on the side of torso, and N = 47 for patients who received the DTP-system on the side of torso.
Arm/Group Title Upper Back Upper Arm Side of Torso
Hide Arm/Group Description:
DTP-system and placebo patch applied to opposite sides of the upper back.
DTP-system and placebo patch applied to the upper part of opposite arms.
DTP-system and placebo patch applied to opposite sides of torso.
Overall Number of Participants Analyzed 48 48 47
Measure Type: Number
Unit of Measure: participants
Placebo, Score >1 9 5 5
DTP-System, Score >1 7 2 2
Placebo, Score >2 2 1 1
DTP-System, Score >2 1 0 0
5.Primary Outcome
Title Skin Irritation (Papules and Vesicles)
Hide Description Papules and vesicles were assessed according to the following scoring criteria: Score 0 = no evidence of papules or vesicles; Score 1 = few papules or vesicles (< 10) observed on the skin site; Score 2 = more papules or vesicles (≥ 10) observed on < 50 % of skin site, diffuse or few clusters; Score 3 = many papules or vesicles observed on ≥ 50% of skin site, diffuse or few clusters; Score 4 = many papules or vesicles observed on > 50% of skin site, with multiple (> 3) clusters.
Time Frame 1, 24, and 48 hours after patch removal (Days 8-10; Days 15-17; Days 22-24)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received patches are included in the analysis.
Arm/Group Title Upper Back Upper Arm Side of Torso
Hide Arm/Group Description:
DTP-system and placebo patch applied to opposite sides of the upper back.
DTP-system and placebo patch applied to the upper part of opposite arms.
DTP-system and placebo patch applied to opposite sides of torso.
Overall Number of Participants Analyzed 49 48 47
Measure Type: Number
Unit of Measure: participants
1 hour after patch removal, Placebo, Score >1 9 6 5
1 hour after patch removal, DTP-System, Score >1 7 2 2
1 hour after patch removal, Placebo, Score >2 2 1 1
1 hour after patch removal, DTP-System, Score >2 1 0 0
24 hours after patch removal, Placebo, Score >1 5 4 4
24 hours after patch removal, DTP-System, Score >1 5 2 2
24 hours after patch removal, Placebo, Score >2 2 1 1
24 hours after patch removal, DTP-System, Score >2 0 0 0
48 hours after patch removal, Placebo, Score >1 5 2 3
48 hours after patch removal, DTP-System, Score >1 5 1 1
48 hours after patch removal, Placebo, Score >2 2 1 1
48 hours after patch removal, DTP-System, Score >2 0 0 0
6.Primary Outcome
Title Skin Irritation (Other Skin Effects)
Hide Description Other skin effects were assessed according to the following scoring criteria: Score 0 = no other effects observed; Score 1 = slight glazed appearance; Score 2 = marked glazing; Score 3 = glazing with peeling and cracking; Score 4 = glazing with fissures; Score 5 = film of dried serous exudate covering all or part of the patch site; Score 6 = small petechial erosions and/or scabs.
Time Frame Immediately after patch removal
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received patches are included in the analysis. Note: The represented data are based on N = 48 for patients who received the placebo patch and the DTP-system on the Upper Back, N = 46 for patients who received the placebo patch on the side of torso, and N = 47 for patients who received the DTP-system on the side of torso.
Arm/Group Title Upper Back Upper Arm Side of Torso
Hide Arm/Group Description:
DTP-system and placebo patch applied to opposite sides of the upper back.
DTP-system and placebo patch applied to the upper part of opposite arms.
DTP-system and placebo patch applied to opposite sides of torso.
Overall Number of Participants Analyzed 48 48 47
Measure Type: Number
Unit of Measure: participants
Placebo, Score ≥1 10 9 8
DTP-System, Score ≥1 8 7 8
Placebo, Score =6 2 6 0
DTP-System, Score =6 2 4 2
7.Primary Outcome
Title Skin Irritation (Other Skin Effects)
Hide Description Other skin effects were assessed according to the following scoring criteria: Score 0 = no other effects observed; Score 1 = slight glazed appearance; Score 2 = marked glazing; Score 3 = glazing with peeling and cracking; Score 4 = glazing with fissures; Score 5 = film of dried serous exudate covering all or part of the patch site; Score 6 = small petechial erosions and/or scabs.
Time Frame 1, 24, and 48 hours after patch removal (Days 8-10; Days 15-17; Days 22-24)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received patches are included in the analysis.
Arm/Group Title Upper Back Upper Arm Side of Torso
Hide Arm/Group Description:
DTP-system and placebo patch applied to opposite sides of the upper back.
DTP-system and placebo patch applied to the upper part of opposite arms.
DTP-system and placebo patch applied to opposite sides of torso.
Overall Number of Participants Analyzed 49 48 47
Measure Type: Number
Unit of Measure: participants
1 hour after patch removal, Placebo, Score ≥1 10 9 8
1 hour after patch removal, DTP-System, Score ≥1 9 7 8
1 hour after patch removal, Placebo, Score =6 2 6 0
1 hour after patch removal, DTP-System, Score =6 3 4 2
24 hours after patch removal, Placebo, Score ≥1 3 7 3
24 hours after patch removal, DTP-System, Score ≥1 3 6 3
24 hours after patch removal, Placebo, Score =6 2 5 1
24 hours after patch removal, DTP-System, Score =6 2 3 2
48 hours after patch removal, Placebo, Score ≥1 2 6 1
48 hours after patch removal, DTP-System, Score ≥1 2 5 2
48 hours after patch removal, Placebo, Score =6 2 5 1
48 hours after patch removal, DTP-System, Score =6 2 3 2
8.Secondary Outcome
Title Safety, Tolerability, and Adhesion
Hide Description See Adverse Event section for Safety assessment. Adhesion was assessed according to the following scoring criteria: Score 0 = approximately > 90% adhered (essentially no lift off the skin); Score 1 = approximately 75% to < 90% adhered (some edges only lifting off the skin); Score 2 = approximately 50% to < 75% adhered (less than half of the system lifting off the skin); Score of 3 = approximately < 50% adhered but not detached (more than half of the system lifting off the skin without falling off); Score of 4 = Patch-system detached (patch /overlay completely off the skin).
Time Frame Safety was assessed throughout the study. Adhesion was assessed daily and immediately prior to patch removal on Days 8, 15, and 22.
Outcome Measure Data Not Reported
Time Frame Adverse event data were collected from the time the patient signed the Informed Consent Form until study discharge (Day 24) (3 days after removal of the last patch).
Adverse Event Reporting Description All patients who received study drug were included in the safety summaries. Adverse events (AEs) collected prior to the patient receiving drug were considered baseline signs or symptoms. Any baseline sign or symptom that worsened during the course of the study was considered a treatment-emergent AE.
 
Arm/Group Title Systemic Events DTP-system Placebo Patch
Hide Arm/Group Description All enrolled patients Localized events Localized events
All-Cause Mortality
Systemic Events DTP-system Placebo Patch
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Systemic Events DTP-system Placebo Patch
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/49 (2.04%)      0/49 (0.00%)      0/49 (0.00%)    
Respiratory, thoracic and mediastinal disorders       
Cough  1  1/49 (2.04%)  1 0/49 (0.00%)  0/49 (0.00%) 
Increased upper airway secretion  1  1/49 (2.04%)  1 0/49 (0.00%)  0/49 (0.00%) 
Dyspnoea  1  1/49 (2.04%)  1 0/49 (0.00%)  0/49 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Systemic Events DTP-system Placebo Patch
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/49 (6.12%)      14/49 (28.57%)      15/49 (30.61%)    
General disorders       
Application site pruritus  1  0/49 (0.00%)  14/49 (28.57%)  15/49 (30.61%) 
Psychiatric disorders       
Confusional State  1  3/49 (6.12%)  0/49 (0.00%)  0/49 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
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.
An Institution Publication may be published provided that it does not disclose Confidential Information other than the study results from the Institution’s study data. The proposed Institution Publication shall be submitted to sponsor for review and comment at least 30 days prior to submitting it to a third party. If sponsor requests a delay in order to file patent applications, the Institution Publication may be delayed for submission to a third party for up to 120 days after sponsor request.
Results Point of Contact
Name/Title: Director of Clinical Trials
Organization: Teikoku Pharma USA, Inc.
Phone: (408) 501-1821
Responsible Party: Teikoku Pharma USA, Inc.
ClinicalTrials.gov Identifier: NCT00916383     History of Changes
Other Study ID Numbers: TPU-TAD-US02-0810
First Submitted: June 5, 2009
First Posted: June 9, 2009
Results First Submitted: March 24, 2016
Results First Posted: April 22, 2016
Last Update Posted: April 22, 2016