Contact Sensitization Potential of 828 Ointment

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

Contact sensitization by patch applications.

Key facts

Study ID

NCT00767676

Run by

Healthpoint

People needed

259

Starts

2008-10-01

Expected to finish

2008-11-01

Last updated by the study team

2014-06-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects must satisfy all of the following criteria:
• Subjects must be ambulatory, 18 to 65 years of age and in reasonably good health (no physical required).
• Subjects may be of any race 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.
• 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 entire study.
• Bathing is permitted but subjects must agree to try and keep the patches as dry as possible.
• Subjects must read and sign the informed consent statement.
• All females of child bearing potential must agree to take an entry and exit urine pregnancy test

You may not qualify if…

• 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 Draize type 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 (at the test sites), 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.
• 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 a least one month prior to receiving study drug and continue same regimen throughout the study.
• Bilateral mastectomy for cancer involving removal of lymph nodes.
• Treatment of any type of cancer within the last six months.
• The Investigator may declare any subject ineligible for a sound medical reason.
• Subjects with allergies/known sensitivities to any of the ingredients of the test article.

Where it is running

• RCTS, Inc. — Irving, Texas, United States

Full record on ClinicalTrials.gov

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