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

NCT00916383 | Completed Phase 2 Results

• 1 other identifier: TPU-TAD-US02-0810
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 7

Brief 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. The total application time for the DTP-system is 21 days.

Conditions

Irritation/Irritant

Keywords

Skin Irritation; Donepezil Transdermal Patch System; Elderly; Alzheimer's subjects; Skin Irritation in elderly Alzheimer's subjects

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  1, 24, and 48 hours after patch removal (Days 8-10; Days 15-17; Days 22-24)

Secondary Outcomes (1)

• Safety, Tolerability, and Adhesion

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

Study Arms (3)

Upper Back

EXPERIMENTAL

350 mg Donepezil Transdermal Patch (active) and placebo patch, each applied to opposite sides of the upper back.

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.

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.

Drug: 350 mg Donepezil Transdermal Patch; Drug: Placebo Patch

Interventions

350 mg Donepezil Transdermal Patch DRUG

Active and placebo patches will be applied to opposite sides for 7 days.

Side of Torso; Upper Arm; Upper Back

Placebo Patch DRUG

Active and placebo patches will be applied to opposite sides for 7 days.

Side of Torso; Upper Arm; Upper Back

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Teikoku Pharma USA, Inc.: lead

Study Sites (7)

Xenoscience, Inc

Phoenix, Arizona, 85004, United States

Location

Margolin Brain Institute

Fresno, California, 93720, United States

Location

Collaborative Neuroscience Network, Inc

Garden Grove, California, 92845, United States

Location

Synergy Clinical Research Center

National City, California, 91950, United States

Location

Apex Research Institute

Santa Ana, California, 92705, United States

Location

Meridien Research

Brooksville, Florida, 34613, United States

Location

Miami Jewish Home and Hospital for the Aged

Miami, Florida, 33137, United States

Location

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Teikoku Pharma USA, Inc.

(408) 501-1821

Study Officials

• James Song, MS, MBA

  Teikoku Pharma USA, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2009
• First Posted: June 9, 2009
• Study Start: May 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: October 28, 2021
• Results First Posted: April 22, 2016

Record last verified: 2016-04

Locations

US (7)