Don't get left behind! The modernized is coming. Check it out now.
Say goodbye to!
The new site is coming soon - go to the modernized
Working… Menu

Evaluation of Adhesion and Dermal Tolerability of EMSAM

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. Identifier: NCT00531596
Recruitment Status : Completed
First Posted : September 19, 2007
Last Update Posted : September 19, 2007
Information provided by:
Somerset Pharmaceuticals

Brief Summary:
Examine adhesive and dermal tolerability of EMSAm 6mg/24hr and 12mg/24hr in healthy elderly and non-elderly subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: EMSAM (Selegiline Transdermal System) 6mg/24Hr Drug: EMSAM (Selegiline Transdermal System) 9mg/24Hr Drug: EMSAM (Selegiline Transdermal System) 12mg/24hr Phase 4

Detailed Description:

The primary objectives of this study are to examine the adhesion characteristics and dermal tolerability (irritation) of EMSAM in two populations consisting of non-elderly (18 - 64 years) and elderly (65 years and older) healthy volunteers. EMSAM will be dosed over the range of proposed sizes for marketing [(6mg/24hr), (9mg/24hr), and (12mg/24hr)]. Adhesion and tolerability (irritation) will be examined at three different application site areas (upper torso [includes chest and back], upper arm, and upper thigh).

The secondary objective is to examine if the adhesion characteristics and dermal tolerability (irritation) of EMSAM may be influenced by the secondary factors such as gender, race, physical activity, and bathing/showering practices.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Study Start Date : April 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arm Intervention/treatment
Active Comparator: A
EMSAM 6mg/24hr
Drug: EMSAM (Selegiline Transdermal System) 6mg/24Hr
EMSAM 6mg/24HR

Active Comparator: B
EMSAM 9mg/24Hr
Drug: EMSAM (Selegiline Transdermal System) 9mg/24Hr
EMSAM 9mg/24Hr

Active Comparator: C
EMSAM 12mg/24Hr
Drug: EMSAM (Selegiline Transdermal System) 12mg/24hr
EMSAM 12mg/24Hr

Primary Outcome Measures :
  1. Adhesion characteristics and dermal tolerability (irritation) of EMSAM in two populations consisting of non-elderly (18 - 64 years) and elderly (65 years and older) healthy volunteers. [ Time Frame: 21 Days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

To be eligible for study participation, subjects will meet the following criteria:

  • Able and willing to provide written informed consent.
  • Able and willing to follow a modified diet.
  • 18 years of age and older.
  • Male or female.
  • If female and of childbearing potential, subject must have a negative pregnancy screen at baseline and may not be lactating. Females of childbearing potential must demonstrate use of an acceptable form of birth control, such as hormonal contraceptive, intrauterine device or barrier method (i.e. condom w/spermicide). NOTE: Abstinence and partner vasectomy are not acceptable methods of contraception.
  • In general good health as ascertained by physical examination, supine and standing vital signs, laboratory test results, 12 lead ECG and medical history.

Exclusion Criteria:

Any of the following conditions will exclude subjects from eligibility for study participation:

  • Subjects with a past or present condition that includes any of the following:

    1. In the opinion of the Investigator, any significant cardiovascular disease or disorder including myocardial infarction, cardiac arrhythmia, hypertension or recurrent episodes of orthostatic hypotension.
    2. Any skin abnormalities at or near designated patch application sites that might interfere with the conduct or interpretation of the study including the presence of moles, blemishes, excess hair, scars, tattoos, sunburn or other marks on the application sites that may obscure grading of the site(s).
    3. Any known hypersensitivity, or related hypersensitivity, to selegiline or to skin adhesives (i.e. surgical tape, etc.).
    4. Any significant immunological, pulmonary, hematologic, endocrine and/or metabolic disease or disorder or severe or acute medical illness, such as, metastatic cancer, brain tumors, decompensated cardiac, hepatic or renal failure.
    5. Neurological disorders including delirium, history of significant head trauma, movement disorders, dementia, multiple sclerosis or stroke.
    6. Any psychiatric disorders (except personality disorders) requiring treatment or therapy within the last three months.
    7. Any mood disorder including MDD which is current or relapsed over the past three years.
    8. Attention deficit hyperactivity disorder or attention deficit disorder.
    9. Any other condition, illness or disorder that in the opinion of the Investigator would place the subject at significant risk or any inability to follow the requirements of the study regarding maintaining scheduled visits or patch applications.
    10. Known substance abuse or addiction.
    11. Any significant allergy, especially involving dermal manifestations.
    12. History of sun hypersensitivity and photosensitive dermatoses.
  • Recent or current treatment with systemic or topical drugs or medications which can interfere with skin responses (i.e. steroids, corticosteroids, antihistamines or anti-inflammatory agents). Daily regimens of low-dose aspirin is acceptable.
  • Current or anticipated use of meperidine, tricyclic antidepressants, or selective serotonin reuptake inhibitors (i.e., fluoxetine [Prozac], etc) and other antidepressant medications (e.g., SNRI's, MAOI's, buproprion, etc).
  • Use of any herbal or homeopathic remedies (excluding vitamins, fish oil, echinacea, glucosamine, chondroitin or calcium)within 14 days of study drug administration, during study conduct and 14 days after the completion of the study medication.
  • Participation in a clinical investigation within 28 days prior to baseline.
  • Current use of any agents listed as contraindicated (Section or as listed in the approved label

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00531596

Layout table for location information
United States, Arizona
Hill Top Research
Scottsdale, Arizona, United States
United States, Florida
Hill Top Research
St. Petersburg, Florida, United States
Sponsors and Collaborators
Somerset Pharmaceuticals
Layout table for investigator information
Study Chair: Melissa Goodhead Somerset Pharmaceuticals
Layout table for additonal information Identifier: NCT00531596    
Other Study ID Numbers: S9303-P0602
First Posted: September 19, 2007    Key Record Dates
Last Update Posted: September 19, 2007
Last Verified: September 2007
Keywords provided by Somerset Pharmaceuticals:
Non Elderly
Healthy Volunteers
Additional relevant MeSH terms:
Layout table for MeSH terms
Tissue Adhesions
Pathologic Processes
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs