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Study of the Intradermal Injection of rHuPH20 or Placebo in Subjects With Nickel Allergic Contact Dermatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Halozyme Therapeutics
ClinicalTrials.gov Identifier:
NCT00928447
First received: June 25, 2009
Last updated: September 10, 2012
Last verified: September 2012
  Purpose

The purpose of this study is to compare the effect and safety of rHuPH20 or placebo for the treatment of skin allergic reaction to nickel. The study drug and placebo will be administered by intradermal injection.


Condition Intervention Phase
Dermatitis, Allergic Contact
Drug: rHuPH20
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Single-Center Study of the Intradermal Injection of rHuPH20 or Placebo in Subjects With Nickel Allergic Contact Dermatitis

Resource links provided by NLM:


Further study details as provided by Halozyme Therapeutics:

Primary Outcome Measures:
  • Determine the treatment effect of rHuPH20 or placebo control injection on the exposure to topical nickel allergen [ Time Frame: 7-14 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determine the time to onset and severity of the cutaneous reaction to nickel allergen after pre-treatment with rHuPH20 or placebo control [ Time Frame: 7-14 days ] [ Designated as safety issue: Yes ]
  • Assess the safety and tolerability of the rHuPH20 injection [ Time Frame: 7-14 days ] [ Designated as safety issue: Yes ]

Enrollment: 22
Study Start Date: June 2009
Study Completion Date: October 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Treatment effect of rHuPH20 injection on the exposure to topical nickel allergen
Drug: rHuPH20
ID syringe push bolus injection of either rHuPH20 or placebo control. Each injection will be administered once daily for 5 days.
Other Name: rHuPH20
Placebo Comparator: 2
Treatment effect of placebo control injection on the exposure to topical nickel allergen
Drug: rHuPH20
ID syringe push bolus injection of either rHuPH20 or placebo control. Each injection will be administered once daily for 5 days.
Other Name: rHuPH20

Detailed Description:

This is a pilot Phase II, prospective, double-blind, placebo-controlled study to compare the efficacy, safety and tolerability of rHuPH20 or placebo control administered intradermally (ID) in the prevention and treatment of subjects with contact allergy to nickel. This study will involve two treatment regimens, which will run in parallel (Treatment Regimens 1 and 2).

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Females 18-60 years of age. Females of child-bearing potential must use a standard and effective means of birth control for the duration of the study.
  • Known contact dermatitis to nickel with a confirmed positive patch-test result to nickel sulfate.
  • Intact normal skin without potentially obscuring tattoos, acne, dermatitis, pigmentation or lesions on the posterior aspect of the torso (back) in the area intended for allergen testing and dose administration.
  • Vital signs (BP, HR, temperature, respiratory rate) within normal range or, if out of range, assessed by the Investigator as not clinically significant and it is mutually agreed by both Investigator and Sponsor Medical Monitor that the subject need not be excluded from the study for this reason.
  • A negative serum or urine pregnancy test (if female of child-bearing potential) within 14 days of initial study drug administration.
  • Subject should be in good general health based on medical history and physical examination, without medical conditions that might prevent the completion of study drug injections and assessments required in this protocol.
  • Decision-making capacity and willingness and ability to comply with the requirements for full completion of the study.
  • Signed, written Institutional Review Board (IRB)/EC-approved informed consent.

Exclusion Criteria:

  • Nickel allergen patch test greater than a ++ reaction.
  • Subjects who were treated with chemotherapy agents or systemic corticosteroids within the past 3 months.
  • Use of topical steroids, antihistamines, or immunosuppressants used near the site of allergen testing/injection within 14 days.
  • Use of oral antihistamines within 14 days of study conduct.
  • Extensive ongoing outbreaks of contact dermatitis anywhere on the body.
  • Pregnant or women who are breast-feeding.
  • Subjects with a current disease state that can affect immune response (e.g., flu, cancer, HIV).
  • Known allergy to any hyaluronidase or the ingredients in the dose preparation.
  • History of autoimmune disorder.
  • Subjects with any other medical condition that, in the opinion of the investigator, might significantly affect their ability to safely participate in the study or affect the conduct of this study. Examples might include asthma, diabetes, heart disease, epilepsy, cancer, etc.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00928447

Locations
United States, Indiana
Symbio Phase I Unit, Saint Anthony Memorial Research Center
Michigan City, Indiana, United States, 46360
Sponsors and Collaborators
Halozyme Therapeutics
Investigators
Principal Investigator: Ikeadi M Ndukwu, M.D., MPH Saint Anthony Memorial Research Center
  More Information

No publications provided

Responsible Party: Halozyme Therapeutics
ClinicalTrials.gov Identifier: NCT00928447     History of Changes
Other Study ID Numbers: HALO-114-201
Study First Received: June 25, 2009
Last Updated: September 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Halozyme Therapeutics:
rHuPH20
Recombinant Human hyaluronidase

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Allergic Contact
Dermatitis, Contact
Hypersensitivity
Hypersensitivity, Delayed
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous

ClinicalTrials.gov processed this record on November 23, 2014