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
Sponsor study identifier
interventional
22
1 country
1
Study Start
June 23, 2009
Actual (reported)Primary Completion
September 13, 2009
Actual (reported)Study Completion
September 13, 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 13, 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 23, 2009
Actual (reported)June 25, 2009
Actual (reported)June 26, 2009
Actual (reported)September 13, 2009
Actual (reported)September 13, 2009
Actual (reported)December 17, 2021
Actual (reported)Number of Participants With Positive Reaction Scores Based Upon ICDRG Scoring Scale: Regimen 1
Cutaneous reactions at the patch test sites were scored according to the ICDRG scoring scale as Grade 0 (-)= Negative reaction, Grade 1/2 (?)= Doubtful reaction; faint macular erythema only, Grade 1 (1+)= Weak (nonvesicular) positive reaction; erythema, infiltration, papules, vesicles, Grade 2 (2+): Strong (vesicular) positive reaction; erythema, infiltration, papules, vesicles, Grade 3 (3+): Extreme positive reaction; bullous reaction Grade NA (IR): Irritant reaction of different types. Participants with positive reaction scores (\>= Grade 1) have been reported in this outcome measure.
Day 3 (48 hours post-dose after the patch removal for Regimen 1) up to Day 14
Number of Participants With Positive Reaction Scores Based Upon ICDRG Scoring Scale: Regimen 2
Cutaneous reactions at the patch test sites were scored according to the ICDRG scoring scale as Grade 0 (-)= Negative reaction, Grade 1/2 (?)= Doubtful reaction; faint macular erythema only, Grade 1 (1+)= Weak (nonvesicular) positive reaction; erythema, infiltration, papules, vesicles, Grade 2 (2+): Strong (vesicular) positive reaction; erythema, infiltration, papules, vesicles, Grade 3 (3+): Extreme positive reaction; bullous reaction Grade NA (IR): Irritant reaction of different types. Participants with positive reaction scores (\>= Grade 1) have been reported in this outcome measure.
Day 3 (48 hours post-dose after the patch removal for Regimen 2) up to Day 14
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
Day 3 (48 hours post-dose after the patch removal for Regimen 1)
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
Day 3 (48 hours post-dose after the patch removal for Regimen 2)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Baseline up to Day 14
Participant's upper back will be divided into 2 equal spaces and will receive Regimen 1 and 2 in 4 spaces respectively. In Regimen 1, a single row of 4 patches, each with the nickel sulfate concentration (NSC) (1, 2.5, or 5%) determined at screening, will be applied to the upper space at Day 1. After 48 hours, the patches will be removed and the reactions will be graded on the ICDRG scale. An ID injection containing rHuPH20 (3,000 Units \[U\]) will be administered once daily (QD) for 5 days at the center of each area of reaction. In Regimen 2, a single row of 4 sites in the lower space will be injected intradermally with drug rHuPH20 (3,000 U) at Day 1. Ten minutes after the injections, patches with the NSC (1, 2.5, or 5%) determined at screening will be applied to the injection sites. After 48 hours, the patches will be removed and the reactions will be graded on the ICDRG scale. As during pretreatment, an ID injection containing rHuPH20 will be then administered QD for 5 days.
Participant's upper back will be divided into 2 equal spaces and will receive Regimen 1 and 2 in 4 spaces respectively. In Regimen 1, a single row of 4 patches, each with the NSC (1, 2.5, or 5%) determined at screening, will be applied to the upper space at Day 1. After 48 hours, the patches will be removed and the reactions will be graded on the ICDRG scale. An ID injection containing placebo will be administered QD for 5 days at the center of each area of reaction. In Regimen 2, a single row of 4 sites in the lower space will be injected intradermally with placebo at Day 1. Ten minutes after the injections, patches with the NSC (1, 2.5, or 5%) determined at screening will be applied to the injection sites. After 48 hours, the patches will be removed and the reactions will be graded on the ICDRG scale. As during pretreatment, an ID injection containing placebo will be then administered QD for 5 days.
0.25 milliliter (mL) Intradermal (ID) syringe push bolus injection of rHuPH20
0.25 mL ID syringe push bolus injection of placebo control
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Symbio Phase I Unit, Saint Anthony Memorial Research Center
Michigan City, Indiana, 46360, United States
Ikeadi M Ndukwu, M.D., MPH
Saint Anthony Memorial Research Center
22 participants (actual enrollment reported by the registry).
First Submitted
June 25, 2009
First Posted
June 26, 2009
Study Start
June 23, 2009
Actual (reported)Immune Reactions in Contact Dermatitis Affected Skin
Contact the study team to confirm eligibility.
Primary Completion
September 13, 2009
Actual (reported)Study Completion
September 13, 2009
Actual (reported)Last Updated
December 17, 2021
Results First Posted
December 17, 2021
Record last verified: 2021-11
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Source: ClinicalTrials.gov.
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