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NI-0801 in Allergic Contact Dermatitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01244607
First Posted: November 19, 2010
Last Update Posted: November 19, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NovImmune SA
  Purpose
The purpose of the study is to assess the effect of a single dose of NI-0801 on the severity of nickel-induced allergic contact dermatitis.

Condition Intervention Phase
Allergic Contact Dermatitis Drug: Placebo Drug: NI-0801 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Official Title: A Proof-of-Principle Study Investigating the Effect of Single Doses of NI-0801 on Nickel Induced Contact Dermatitis

Further study details as provided by NovImmune SA:

Primary Outcome Measures:
  • Effect of NI-0801 administration on the severity of the cutaneous response to Nickel challenge as measured using the score system of the DKG (Deutsche Kontakt-Allergie Gruppe).

Secondary Outcome Measures:
  • Safety and tolerability of NI-0801 as measured by the incidence and severity of treatment emergent adverse events.

Enrollment: 22
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
single i.v. administration
Experimental: NI-0801 Drug: NI-0801
single i.v. administration

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged ≥ 18 and ≤ 70 years
  • Either male or a female lacking childbearing potential
  • Previously documented nickel allergy

Exclusion Criteria:

  • Any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial or that would prevent subjects from providing informed consent.
  • Known or previous diagnosis of malignancy
  • Known current active tuberculosis or a history of active TB within 12 months of screening
  • Known infection with HIV, Hepatitis B or C
  Contacts and Locations
No Contacts or Locations Provided
  More Information

ClinicalTrials.gov Identifier: NCT01244607     History of Changes
Other Study ID Numbers: NI-0801-02
First Submitted: November 16, 2010
First Posted: November 19, 2010
Last Update Posted: November 19, 2010
Last Verified: November 2010

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