Contact Sensitization Potential of 828 Ointment

NCT00767676 | Completed Phase 1 Results

• 1 other identifier: 828-101-09-011
• Study Type: interventional
• Target: 259
• Locations: 1 country
• Sites: 1

Brief Summary

Contact sensitization by patch applications.

Conditions

Healthy Volunteers

Keywords

Contact sensitization; Healthy Adult Volunteers

Outcome Measures

Primary Outcomes (1)

• Number of Participants That Exhibited a Score Less Than 1.5 on the Jordan-King Scale

  To qualify for the claim of a reduced sensitization potential, all subjects completing the study could exhibit a value of no more than 1.5 on the Jordan-King Scale \[scale is 0 (no visible reaction) to 5 (severe erythema)\] No statistical analyses were performed.

  7 weeks

Study Arms (1)

1

OTHER

Device: HP828-101

Interventions

HP828-101 DEVICE

Nine topical patch applications over 3 weeks, rest period of 2 weeks and challenge after 48 hours.

1

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 (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.

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: NON 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: June 27, 2014
• Results First Posted: June 27, 2014

Record last verified: 2014-06

Locations

US (1)