Irritation/IrritantPhase 2DTP-SystemNCT00916383

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

A Phase 2 study testing 350 mg Donepezil Transdermal Patch in people with Irritation/Irritant, run by Teikoku Pharma USA, Inc. at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is designed to assess skin tolerability, skin irritation, and adhesion of the 350 mg Donepezil Transdermal Patch (DTP-system), following 3, 7-day applications to 3 specific areas of the body (upper back, upper middle arm, side of torso) of elderly Alzheimer's patients. Read more about this study

Who is it for?: Ages 65 years and older
Conditions the study is for: Irritation/Irritant
What is being tested?: 350 mg Donepezil Transdermal Patch
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 49 participants
Where: 7 sitesUnited States
Study dates: May 2009to Jun 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

Male or female at least 65 years of age.
Established dose of Aricept 10 mg at least 2 months prior to enrollment.
Established diagnosis of stable Alzheimer's disease treated with oral Aricept
Must be willing to change from oral Aricept to DTP (and placebo patch).
Body mass index of at least 18 and a minimum weight of at least 45 kg.
Blood pressure (sitting) must be diastolic <95mmHg, and systolic <145, stable for at least 3 months. Patients with well-controlled hypertension (with medication) may enroll as long as 3-month stability criterion is met.

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Those with stable cardiac disease may be enrolled provided the patient has been on appropriate medication for 3 months prior to screening. Those with a pacemaker may be enrolled.
Pulse rate between 45 - 100 bpm; respirations between 8 - 20 per minute.
Those with thyroid disease may enroll if stable on treatment for at least 3 months prior to screening, and maintain the same dose of thyroid medication throughout the study.
Must have a caregiver who is either living with the patient or is in daily contact with the patient, agrees to be present at all visits, provide information as required, and ensure compliance with the medication schedule.
Free from any abnormality at Screening which may compromise the patient's ability to participate.
Free of any dermatologic conditions, excessive hair or skin allergies and sensitivities.
Male patients who have female partners of childbearing potential must use a condom.
Must understand and provide written informed consent (or have a Legally Authorized Representative who is able), prior to the initiation of any protocol-specific procedures.
Must be willing and able to abide by all study requirements and restrictions.
Must be on stable medications for at least 30 days prior to enrollment into the study.

Who cannot join

Use of systemic or topical antihistamines within 72 hours prior to enrollment, or systemic or topical corticosteroids within 3 weeks of study enrollment or foreseen use during the study.
History of allergy to Donepezil hydrochloride or to piperidine derivatives, related drugs, or any of the drug excipients or other drug product components.
Those with a recent (< 2 years) cancer (except for non-melanoma skin cancers, females with in-situ cancer of the cervix or males with localized prostate cancer requiring no treatment).
Presence of history of a psychiatric disorder, or other seizure disorder deemed clinically significant.
Those with a known plan for elective surgery during the study period.
Those taking antidepressant medication.

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Abnormality (e.g., scar, tattoo) or unhealthy skin (e.g., burns, wounds) at the application site; or an existing chronic skin disease or history of skin disease at the application site(s) within the 30 days prior to enrollment.
Treatment with any investigational drug within 30 days prior to enrollment in the study.
Any condition which would make the patient or caregiver, in the opinion of the investigator or designee, not suitable for the study for any reason.
Current or pending legal charges that may affect patient or caregiver compliance.
Treatment with medications contraindicated for use with Aricept

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Meridien Research
Brooksville, Florida, 34613
Margolin Brain Institute
Fresno, California, 93720
Collaborative Neuroscience Network, Inc
Garden Grove, California, 92845
Miami Jewish Home and Hospital for the Aged
Miami, Florida, 33137
Synergy Clinical Research Center
National City, California, 91950
Xenoscience, Inc
Phoenix, Arizona, 85004
Apex Research Institute
Santa Ana, California, 92705

Other trials in United States

About this study

Official title: Randomized, Placebo-Controlled Study in Elderly Alzheimer's Patients on Established/Well Tolerated Dose of Aricept to Assess Skin Tolerability, Irritation, Adhesion With 3 Consecutive 7-Day Applications of 350 mg Donepezil Transdermal Patch

Read the detailed description

This is a randomized, placebo-controlled study designed to evaluate skin irritation, skin tolerability, and adhesion of the 350 mg DTP-system following 3 consecutive 7-day applications to 3 specific areas of the body (upper back, upper arm, side of torso) of elderly Alzheimer's patients. The total exposure time for the DTP-system is 21 days.

All patients receive 1 Donepezil Transdermal Patch (DTP-system) and 1 placebo patch, each applied to opposite sides of the body (e.g., placebo patch to the left side of the upper back, and DTP-system to the right side of the upper back). Patients are randomized to receive the active patch to either the left or the right side of the body according to 1 of 6 treatment sequences listed below. The treatment sequence is repeated for the opposite side of the body for a total of 12 treatment sequences (4 patients in each treatment sequence). The patches are applied to one of 3 body locations for 7 days, for a total exposure period of 21 days, according to one of the following sequences:

Upper Back, Upper Arm, Side of Torso (Right)
Upper Arm, Side of Torso, Upper Back (Right)
Side of Torso, Upper Back, Upper Arm (Right)
Upper Back, Side of Torso, Upper Arm (Right)
Upper Arm, Upper Back, Side of Torso (Right)
Side of Torso, Upper Arm, Upper Back (Right)
Upper Back, Upper Arm, Side of Torso (Left)
Upper Arm, Side of Torso, Upper Back (Left)
Side of Torso, Upper Back, Upper Arm (Left)
Upper Back, Side of Torso, Upper Arm (Left)
Upper Arm, Upper Back, Side of Torso (Left)
Side of Torso, Upper Arm, Upper Back (Left)

Patches are applied on Days 1, 8, and 15 according to the randomization schedule. Oral Aricept is taken daily through Day -1, and is re-started on Day 22 or at the time of early termination if before Day 22. Patients are seen in the clinic at Screening and on Days 1, 8, 15, 22, and at the End of Study Visit; for all other daily visits, the patients may be seen either at the clinic or in their residence, provided the assessments are completed as described in the protocol. Skin irritation is assessed immediately upon patch removal and at 1, 24, and 48 hours after removal.

Conditions: Irritation/Irritant
Being tested: 350 mg Donepezil Transdermal Patch, Placebo Patch
Keywords: Skin Irritation, Donepezil Transdermal Patch System, Elderly, Alzheimer's subjects, Skin Irritation in elderly Alzheimer's subjects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

350 mg Donepezil Transdermal PatchDrug
Active and placebo patches will be applied to opposite sides for 7 days.
Placebo PatchDrug
Active and placebo patches will be applied to opposite sides for 7 days.

Study groups in NCT00916383
Study group	Role	What they receive
Upper Back	Experimental	350 mg Donepezil Transdermal Patch (active) and placebo patch, each applied to opposite sides of the upper back. Receives: Drug: 350 mg Donepezil Transdermal Patch; Drug: Placebo Patch
Upper Arm	Experimental	350 mg Donepezil Transdermal Patch (active) and placebo patch, each applied to opposite arms. Receives: Drug: 350 mg Donepezil Transdermal Patch; Drug: Placebo Patch
Side of Torso	Experimental	350 mg Donepezil Transdermal Patch (active) and placebo patch, each applied to opposite sides of torso. Receives: Drug: 350 mg Donepezil Transdermal Patch; Drug: Placebo Patch

What is being measured

The primary outcome is the main question the study is designed to answer.

Skin Irritation (Erythema and Edema)
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.
Measured: Immediately after patch removal
Skin Irritation (Erythema)
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.
Measured: 1, 24, and 48 hours after patch removal (Days 8-10; Days 15-17; Days 22-24)
Skin Irritation (Edema)
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.
Measured: 1, 24, and 48 hours after patch removal (Days 8-10; Days 15-17; Days 22-24)
Skin Irritation (Papules and Vesicles)
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.
Measured: Immediately after patch removal
Skin Irritation (Papules and Vesicles)
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.
Measured: 1, 24, and 48 hours after patch removal (Days 8-10; Days 15-17; Days 22-24)
Skin Irritation (Other Skin Effects)
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.
Measured: Immediately after patch removal
Skin Irritation (Other Skin Effects)
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.
Measured: 1, 24, and 48 hours after patch removal (Days 8-10; Days 15-17; Days 22-24)

Secondary outcomes (1)

Safety, Tolerability, and Adhesion
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).
Measured: Safety was assessed throughout the study. Adhesion was assessed daily and immediately prior to patch removal on Days 8, 15, and 22.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2009Jun 2009

First posted9 Jun 2009 (estimated)
Study startMay 2009
Primary completionJun 2009
Study completionJun 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Irritation/IrritantStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00916383
Sponsor's protocol ID: TPU-TAD-US02-0810
Acronym: DTP-System
Status last verified: Apr 2016
First submitted: 5 Jun 2009
Last updated: 28 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Placebo-Controlled Study in Elderly Alzheimer's Patients on Established/Well Tolerated Dose of Aricept to Assess Skin Tolerability, Irritation, Adhesion With 3 Consecutive 7-Day Applications of 350 mg Donepezil Transdermal Patch
ClinicalTrials.gov ID: NCT00916383
Acronym / sponsor ID: DTP-System / TPU-TAD-US02-0810
Conditions: Irritation/Irritant
Keywords: Skin Irritation, Donepezil Transdermal Patch System, Elderly, Alzheimer's subjects, Skin Irritation in elderly Alzheimer's subjects
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 49 participants (actual)
Lead sponsor: Teikoku Pharma USA, Inc.Industry (pharma, biotech, devices)
Study start: May 2009
Primary completion: Jun 2009 (actual)
Study completion: Jun 2009 (actual)
First posted: 9 Jun 2009 (estimated)
Results: Posted 22 Apr 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Upper Back, Upper Arm, Side of Torso (Right)
Upper Arm, Side of Torso, Upper Back (Right)
Side of Torso, Upper Back, Upper Arm (Right)
Upper Back, Side of Torso, Upper Arm (Right)
Upper Arm, Upper Back, Side of Torso (Right)
Side of Torso, Upper Arm, Upper Back (Right)
Upper Back, Upper Arm, Side of Torso (Left)
Upper Arm, Side of Torso, Upper Back (Left)
Side of Torso, Upper Back, Upper Arm (Left)
Upper Back, Side of Torso, Upper Arm (Left)
Upper Arm, Upper Back, Side of Torso (Left)
Side of Torso, Upper Arm, Upper Back (Left)

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Upper Back	Experimental	Drug: 350 mg Donepezil Transdermal Patch, Drug: Placebo Patch350 mg Donepezil Transdermal Patch (active) and placebo patch, each applied to opposite sides of the upper back.
Upper Arm	Experimental	Drug: 350 mg Donepezil Transdermal Patch, Drug: Placebo Patch350 mg Donepezil Transdermal Patch (active) and placebo patch, each applied to opposite arms.
Side of Torso	Experimental	Drug: 350 mg Donepezil Transdermal Patch, Drug: Placebo Patch350 mg Donepezil Transdermal Patch (active) and placebo patch, each applied to opposite sides of torso.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (16 listed)

Male or female at least 65 years of age.
Established dose of Aricept 10 mg at least 2 months prior to enrollment.
Established diagnosis of stable Alzheimer's disease treated with oral Aricept
Must be willing to change from oral Aricept to DTP (and placebo patch).
Body mass index of at least 18 and a minimum weight of at least 45 kg.

Key exclusion criteria (11 listed)

Use of systemic or topical antihistamines within 72 hours prior to enrollment, or systemic or topical corticosteroids within 3 weeks of study enrollment or foreseen use during the study.
History of allergy to Donepezil hydrochloride or to piperidine derivatives, related drugs, or any of the drug excipients or other drug product components.
Those with a recent (< 2 years) cancer (except for non-melanoma skin cancers, females with in-situ cancer of the cervix or males with localized prostate cancer requiring no treatment).
Presence of history of a psychiatric disorder, or other seizure disorder deemed clinically significant.
Those with a known plan for elective surgery during the study period.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
350 mg Donepezil Transdermal PatchActive and placebo patches will be applied to opposite sides for 7 days.	Drug	Side of Torso, Upper Arm, Upper Back
Placebo PatchActive and placebo patches will be applied to opposite sides for 7 days.	Drug	Side of Torso, Upper Arm, Upper Back

Primary outcome

Skin Irritation (Erythema and Edema)
Time frame: Immediately after patch removal
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.
Skin Irritation (Erythema)
Time frame: 1, 24, and 48 hours after patch removal (Days 8-10; Days 15-17; Days 22-24)
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.
Skin Irritation (Edema)
Time frame: 1, 24, and 48 hours after patch removal (Days 8-10; Days 15-17; Days 22-24)
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.
Skin Irritation (Papules and Vesicles)
Time frame: Immediately after patch removal
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.
Skin Irritation (Papules and Vesicles)
Time frame: 1, 24, and 48 hours after patch removal (Days 8-10; Days 15-17; Days 22-24)
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.
Skin Irritation (Other Skin Effects)
Time frame: Immediately after patch removal
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.
Skin Irritation (Other Skin Effects)
Time frame: 1, 24, and 48 hours after patch removal (Days 8-10; Days 15-17; Days 22-24)
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.

1 secondary outcome

Safety, Tolerability, and Adhesion
Time frame: Safety was assessed throughout the study. Adhesion was assessed daily and immediately prior to patch removal on Days 8, 15, and 22.

Results and safety

Results posted to the registry on 22 Apr 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	49	46

Primary outcome: Skin Irritation (Erythema and Edema)

Time frame: Immediately after patch removal. Mean (Standard Deviation). Unit: units on a scale

Measure	Upper Back n = 48	Upper Arm n = 48	Side of Torso n = 47
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)

Population analysed: 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.

Primary outcome: Skin Irritation (Erythema)

Time frame: 1, 24, and 48 hours after patch removal (Days 8-10; Days 15-17; Days 22-24). Mean (Standard Deviation). Unit: units on a scale

Measure	Upper Back n = 49	Upper Arm n = 48	Side of Torso n = 47
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)

Population analysed: All patients who received patches are included in the analysis.

Primary outcome: Skin Irritation (Edema)

Time frame: 1, 24, and 48 hours after patch removal (Days 8-10; Days 15-17; Days 22-24). Mean (Standard Deviation). Unit: units on a scale

Measure	Upper Back n = 49	Upper Arm n = 48	Side of Torso n = 47
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)

Population analysed: All patients who received patches are included in the analysis.

Primary outcome: Skin Irritation (Papules and Vesicles)

Time frame: Immediately after patch removal. Number. Unit: participants

Measure	Upper Back n = 48	Upper Arm n = 48	Side of Torso n = 47
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

1 secondary outcome is reported in the full results.

Adverse events

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).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Systemic Events	1 of 49 (2%)	3 of 49 (6.1%)	Not reported
DTP-system	0 of 49 (0%)	14 of 49 (28.6%)	Not reported
Placebo Patch	0 of 49 (0%)	15 of 49 (30.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

James Song, MS, MBA study director

Teikoku Pharma USA, Inc.

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 350 mg Donepezil Transdermal Patch in people with Irritation/Irritant, run by Teikoku Pharma USA, Inc. at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Skin Irritation (Erythema and Edema) (time frame: Immediately after patch removal). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00916383.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2021.