Cumulative Irritation Potential of 828 Ointment | NCT00767455

NCT00767455

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Label	Type	Description	Intervention Names
Positive, Negative Controls	Sham Comparator		Device: HP828-101

Name	Type	Description	Arm Group Labels	Other Names
HP828-101	Device	21 day patches	Positive, Negative Controls

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Presence of Cumulative Irritation	Irritancy of each test article was evaluated by assessment of the application sites using the Berger and Bowman Scale. Observed responses (e.g., erythema and edema) were graded according to the protocol-specified grading scale [0 (no visible reaction) to 4 (severe erythema)] for each subject. The relative cumulative irritation potentials of the test article (HP828-101 Ointment) and the negative and positive controls were determined by summing the daily scores of the 21 days of testing; with an overall scale of 0 (no visible reaction from any subjects over the 21 days) to 3360 (severe erythema experienced by every subject over the 21 days).	22 days

Eligibility Module

Eligibility Criteria

1. SUBJECTS 1.1 SUBJECT POPULATION

Subjects will be normal, healthy volunteers of either gender aged 18 to 65 years.

Inclusion Criteria:

Subjects must satisfy all of the following criteria:

Subjects must be ambulatory, 18 to 65 years of age and in reasonably good health.
Subjects may be of any ethnicity or skin type provided their skin pigmentation does not interfere with evaluations.
Female subjects must be surgically sterile, post-menopausal or using an acceptable method of birth control and all females of childbirth potential must be willing to take a urine pregnancy test at the beginning and at the end of the study.
Minor deviations in normal medical history not considered to be clinically significant by the investigator and the sponsor will be permitted.
Subjects must refrain from sunbathing, using tanning salons, swimming or using hot tubs during the course of the study.
Bathing is permitted, however, subjects must agree to attempt to keep the patches as dry as possible.
Subjects must read and sign an IRB approved informed consent form.

Exclusion Criteria:

Subjects with any of the following conditions are not eligible for participation:

Any systemic disease or disorder, complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study (i.e., hepatitis, acute or chronic renal insufficiency).
Use of a prescribed pain medication, prescribed or over-the-counter anti-inflammatory drugs, immunosuppressive drugs or prescribed antihistamine medication (steroid nose drops and/or eye drops are permitted). Use of any over-the-counter pain medication that is ingested in quantities exceeding label instructions.
Subjects who have received an investigational drug or have participated in a patch test within the past 28 days or who are currently participating in or plan to enter a clinical trial.
A history of non-compliance or subjects who are considered potentially unreliable.
A history of skin allergies, including known sensitivity or strong reactions to any cosmetics and/or personal care products, topically prepared medical dressings, tapes or adhesives.
A history of clinically significant skin diseases which may contraindicate participation, including psoriasis, active eczema, atopic dermatitis and active cancer, even if currently controlled through medication.
Current use of topical or oral antibiotics.
Use of topical medications at the test area 2 weeks prior to enrollment or any body lotions/oils/creams at the test area for 48 hours prior to enrollment and throughout the trial.
Female subjects who are pregnant, stop contraceptive measures, expect to become pregnant or who are breast-feeding.
Subjects with any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
Subjects with hematological disorders or immunologic disorders (HIV positive, AIDS and Systemic Lupus Erythematosus).
Subjects with any significant organ abnormality or disorders including gastric ulcer/insulin dependent diabetes.
Subjects with any clinically significant illness (sought medical attention, fever, took prescription medication) within the 4 weeks prior to study entry.
History of asthma, chronic bronchitis or any other bronchospastic condition that requires medication.
Known history of either real or suspected allergy or sensitization to any test article ingredient.
Anticipated change in the use of a systemic medication during the study that may affect the conduct or outcome of the study. Subjects must be stabilized on these medications for at least one month prior to receiving study drug and continue the same regimen throughout the study.
Bilateral mastectomy involving removal of lymph nodes.
Treatment of any type of cancer within the last six months.
The Principal Investigator may declare any subject ineligible for a sound medical reason.

Name	Affiliation	Role
Herbert B Slade, MD	Healthpoint	Study Chair
Innes Cargill, PhD	Healthpoint	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
RCTS, Inc.		Irving	Texas	75062	United States

ID	Title	Description
FG000	HP828-101 vs. Negative Control vs. Positive Control	Each subject was their own control and received patches containing approximately 200 mg of all three (test article, negative control, and positive control)

ID	Title	Description
BG000	HP828-101 vs. Negative Control vs. Positive Control	each subject was their own control and received patches of all (test article, negative control, and positive control)

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Presence of Cumulative Irritation

Irritancy of each test article was evaluated by assessment of the application sites using the Berger and Bowman Scale. Observed responses (e.g., erythema and edema) were graded according to the protocol-specified grading scale [0 (no visible reaction) to 4 (severe erythema)] for each subject. The relative cumulative irritation potentials of the test article (HP828-101 Ointment) and the negative and positive controls were determined by summing the daily scores of the 21 days of testing; with an overall scale of 0 (no visible reaction from any subjects over the 21 days) to 3360 (severe erythema experienced by every subject over the 21 days).

Per protocol

Posted

Number

units on a scale

22 days

ID	Title	Description
OG000	HP828-101	Intervention test article

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	HP828-101 vs. Negative Control vs. Positive Control	each subject was their own control and received patches of all (test article, negative control, and positive control)

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Tape Reaction	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Non-systematic Assessment	None of the adverse events were related to the test article. The four (4) subjects with a moderate adverse event due to tape irritation were discontinued from the study