Cumulative Irritation Potential of 828 Ointment

NCT00767455 | Completed Phase 1 Results

• 1 other identifier: 828-101-09-010
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

Cumulative Irritation Patch Test

Conditions

Healthy Volunteers

Keywords

cumulative irritation; healthy adult volunteers

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Positive, Negative Controls

SHAM COMPARATOR

Device: HP828-101

Interventions

HP828-101 DEVICE

21 day patches

Positive, Negative Controls

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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.

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 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.

Sponsors & Collaborators

• Healthpoint: lead

Study Sites (1)

RCTS, Inc.

Irving, Texas, 75062, United States

Location

Results Point of Contact

• Title: Jaime Dickerson, PhD
• Organization: Smith & Nephew Biotherapeutics

jaime.dickerson@smith-nephew.com

817-302-3914

Study Officials

• Herbert B Slade, MD

  Healthpoint

  STUDY CHAIR

• Innes Cargill, PhD

  Healthpoint

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2008
• First Posted: October 7, 2008
• Study Start: October 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: March 14, 2014
• Results First Posted: March 14, 2014

Record last verified: 2014-01

Locations

US (1)