Clinical trial NCT00928447: Study of the Intradermal Injection of rHuPH20 or Placebo in Participants With Nickel Allergic Contact Dermatitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dermatitis, Allergic Contact
Keywords: rHuPH20
Recombinant Human hyaluronidase
Lead sponsor: Halozyme Therapeutics
Sponsor class: INDUSTRY
First posted: 2009-06-26
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: This study will involve 2 regimens which will run in parallel. Each participant's upper back will be divided into 2 equal spaces for Regimen 1 and 2. Each of the 4 treatment sites in each space will be independently randomized to placebo or rHuPH20 treatment in a 1:1 ratio. Thus, each participant will serve as their own control. Regimen 1 will evaluate the treatment of cutaneous reactions to nickel and Regimen 2 will evaluate the prevention as well as the treatment of cutaneous reactions to nickel. At screening, the nickel sulfate concentration (1%, 2.5%, or 5%) applied to the skin of the upper back with a patch, that will cause no more than a ++ reaction according to the scale of the International Contact Dermatitis Research Group (ICDRG) will be determined. This concentration will be used to elicit cutaneous reactions during the study period.

Eligibility 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 (blood pressure \[BP\], heart rate \[HR\], 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 participant 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.
* Participant 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)/Ethics Committee (EC)-approved informed consent.

Exclusion Criteria:

* Nickel allergen patch test greater than a ++ reaction.
* Participants 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.
* Participants with a current disease state that can affect immune response (for example, flu, cancer, human immunodeficiency virus \[HIV\]).
* Known allergy to any hyaluronidase or the ingredients in the dose preparation.
* History of autoimmune disorder.
* Participants 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.

Primary outcomes:
measure: Number of Participants With Positive Reaction Scores Based Upon ICDRG Scoring Scale: Regimen 1
timeFrame: Day 3 (48 hours post-dose after the patch removal for Regimen 1) up to Day 14
measure: Number of Participants With Positive Reaction Scores Based Upon ICDRG Scoring Scale: Regimen 2
timeFrame: Day 3 (48 hours post-dose after the patch removal for Regimen 2) up to Day 14
Secondary outcomes:
measure: Percentage of Participants With a >=1 Grade Change in ICDRG Score in at Least One Patch Region After Treatment With rHuPH20 or Placebo: Regimen 1
timeFrame: Day 3 (48 hours post-dose after the patch removal for Regimen 1)
measure: Percentage of Participants With a >=1 Grade Change in ICDRG Score in at Least One Patch Region After Treatment With rHuPH20 or Placebo: Regimen 2
timeFrame: Day 3 (48 hours post-dose after the patch removal for Regimen 2)
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to Day 14
Other outcomes:
Locations:
city: Michigan City
country: United States
facility: Symbio Phase I Unit, Saint Anthony Memorial Research Center
state: Indiana
Study officials:
affiliation: Saint Anthony Memorial Research Center
name: Ikeadi M Ndukwu, M.D., MPH
role: PRINCIPAL_INVESTIGATOR
References: