Trial · NCT00928447
Study of the Intradermal Injection of rHuPH20 or Placebo in Participants With Nickel Allergic Contact Dermatitis
NCT00928447, Phase 2, Completed, Halozyme Therapeutics; results first posted 2021-12-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of the Intradermal Injection of rHuPH20 or Placebo in Participants With Nickel Allergic Contact Dermatitis. Trials, record NCT00928447. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00928447
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of the Intradermal Injection of rHuPH20 or Placebo in Participants With Nickel Allergic Contact Dermatitis
- NCT number
- NCT00928447
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- Halozyme Therapeutics
- Conditions
- Dermatitis, Allergic Contact
- Interventions
- rHuPH20, Placebo
- First posted
- 2009-06-26
- Last updated
- 2021-12-17
- Results first posted
- 2021-12-17
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Positive Reaction Scores Based Upon ICDRG Scoring Scale: Regimen 1 | Day 3 (48 hours post-dose after the patch removal for Regimen 1) up to Day 14 | 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. |
| Primary | Number of Participants With Positive Reaction Scores Based Upon ICDRG Scoring Scale: Regimen 2 | Day 3 (48 hours post-dose after the patch removal for Regimen 2) up to Day 14 | 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. |
| Secondary | 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) | 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. |
| Secondary | 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) | 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. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Baseline up to Day 14 | TEAEs were defined as adverse events (AEs) with an onset during or following administration of the first dose of study drug. AEs were defined as any untoward medical occurrence in a participant administered study drug and that did not necessarily have a causal relationship with the study drug. SAEs were defined as any AE that, in the view of either the Investigator or Sponsor, resulted in any of the following outcomes as fatal, life-threatening, required in-participant hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, an important medical event. Adverse Events were only monitored/assessed on the whole participant level irrespective of different treatment regimen. A summary of all SAEs and Other AEs (nonserious) regardless of causality is located in 'Reported Adverse Events' Section. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Positive Reaction Scores Based Upon ICDRG Scoring Scale: Regimen 1 | Day 3 (48 hours post-dose after the patch removal for Regimen 1) up to Day 14 | The Evaluable population included all evaluable participants who had completed dosing (or prematurely discontinued the administration due to a toxicity) and had undergone sufficient assessments to allow an assessment of the tolerability of the administration. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Positive Reaction Scores Based Upon ICDRG Scoring Scale: Regimen 2 | Day 3 (48 hours post-dose after the patch removal for Regimen 2) up to Day 14 | The Evaluable population included all evaluable participants who had completed dosing (or prematurely discontinued the administration due to a toxicity) and had undergone sufficient assessments to allow an assessment of the tolerability of the administration. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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) | The Evaluable population included all evaluable participants who had completed dosing (or prematurely discontinued the administration due to a toxicity) and had undergone sufficient assessments to allow an assessment of the tolerability of the administration. | percentage of participants | NUMBER |
| SECONDARY | 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) | The Evaluable population included all evaluable participants who had completed dosing (or prematurely discontinued the administration due to a toxicity) and had undergone sufficient assessments to allow an assessment of the tolerability of the administration. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Baseline up to Day 14 | The Safety population included all participants who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Positive Reaction Scores Based Upon ICDRG Scoring Scale: Regimen 1 | Overall Study (rHuPH20 and Placebo) | rHuPH20 | 5 | Participants | |
| Number of Participants With Positive Reaction Scores Based Upon ICDRG Scoring Scale: Regimen 1 | Overall Study (rHuPH20 and Placebo) | Placebo | 9 | Participants | |
| Number of Participants With Positive Reaction Scores Based Upon ICDRG Scoring Scale: Regimen 2 | Overall Study (rHuPH20 and Placebo) | rHuPH20 | 3 | Participants | |
| Number of Participants With Positive Reaction Scores Based Upon ICDRG Scoring Scale: Regimen 2 | Overall Study (rHuPH20 and Placebo) | Placebo | 2 | Participants | |
| 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 | Overall Study (rHuPH20 and Placebo) | rHuPH20 | 70 | percentage of participants | |
| 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 | Overall Study (rHuPH20 and Placebo) | Placebo | 75 | percentage of participants | |
| 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 | Overall Study (rHuPH20 and Placebo) | rHuPH20 | 95 | percentage of participants | |
| 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 | Overall Study (rHuPH20 and Placebo) | Placebo | 90 | percentage of participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Overall Study (rHuPH20 and Placebo) | TEAEs | 21 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Overall Study (rHuPH20 and Placebo) | SAEs | 0 | Participants |
Source ClinicalTrials.gov
Participant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Overall Study (rHuPH20 and Placebo) | 22 | 176 |
| Overall Study | Received at Least 1 Dose of rHuPH20 | Overall Study (rHuPH20 and Placebo) | 21 | 168 |
| Overall Study | Received at Least 1 Dose of Placebo | Overall Study (rHuPH20 and Placebo) | 21 | 168 |
| Overall Study | COMPLETED | Overall Study (rHuPH20 and Placebo) | 20 | 160 |
| Overall Study | NOT COMPLETED | Overall Study (rHuPH20 and Placebo) | 2 | 16 |
Source ClinicalTrials.gov
Adverse events25
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injection site pain | General disorders | Overall Study (rHuPH20 and Placebo) | 21 | 21 | |
| other | Injection site pruritus | General disorders | Overall Study (rHuPH20 and Placebo) | 18 | 21 | |
| other | Injection site discomfort | General disorders | Overall Study (rHuPH20 and Placebo) | 3 | 21 | |
| other | Injection site haematoma | General disorders | Overall Study (rHuPH20 and Placebo) | 3 | 21 | |
| other | Injection site irritation | General disorders | Overall Study (rHuPH20 and Placebo) | 3 | 21 | |
| other | Feeling hot | General disorders | Overall Study (rHuPH20 and Placebo) | 1 | 21 | |
| other | Headache | Nervous system disorders | Overall Study (rHuPH20 and Placebo) | 10 | 21 | |
| other | Dizziness | Nervous system disorders | Overall Study (rHuPH20 and Placebo) | 4 | 21 | |
| other | Syncope | Nervous system disorders | Overall Study (rHuPH20 and Placebo) | 1 | 21 | |
| other | Nausea | Gastrointestinal disorders | Overall Study (rHuPH20 and Placebo) | 2 | 21 |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Overall Study (rHuPH20 and Placebo) | ||
| Total, other adverse events | Overall Study (rHuPH20 and Placebo) | 21 | 21 |
| Total, serious adverse events | Overall Study (rHuPH20 and Placebo) | 0 | 21 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00928447
GET https://conductscience.org/api/trials/v1/NCT00928447/events?page=2