Trial · NCT02615249
Clinical Evaluation of Metal Panel Allergens: Dose Response Study
NCT02615249, Phase 2, Completed, Allerderm; results first posted 2020-08-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Evaluation of Metal Panel Allergens: Dose Response Study. Trials, record NCT02615249. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02615249
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Evaluation of Metal Panel Allergens: Dose Response Study
- NCT number
- NCT02615249
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 122 participants, actual
- Lead sponsor
- Allerderm
- Conditions
- Dermatitis, Eczematous
- Interventions
- Metal Allergen Epicutaneous Patch
- First posted
- 2015-11-26
- Last updated
- 2020-08-25
- Results first posted
- 2020-08-11
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Patch Test Responses | 21 days post patch application | Allergen patch test sites were scored at Visit 3 (day 3-4) Visit 4 (day 7-8) Visit 5 (day 10-14) and Visit 6 Day 19-23). Determination of positive or negative test response for each allergen dose was assessed by the investigator following the final visit. |
| Secondary | Number of Subjects With Panel Adhesion | Day 2, visit 2 prior to panel removal | Panel Adhesion was measured at Visit 2 (day 2) prior to panel removal according to the following scale: Excellent- Skin contact good; all tape edges adherent; all allergens in contact with the skin, Good- Skin contact acceptable; some tape edges lifting; all allergens in contact with the skin, Poor- Little to no skin contact with panel; one or more allergens not in contact with the skin, Detached- Panel completely off the skin; none of the allergens in contact with the skin |
| Secondary | Tape Irritation | Visit 2 (day 2), visit 3 (day 3-4), visit 4 (day 7-8) visit 5 (day 10-14), visit 6 (day 19-23) with overall assessment by the Investigator following visit 6 | Tape irritation was measured according to the following scale: None- No irritation, Weak- Faint to definite pink erythema, Moderate- Moderate erythema, definite redness, Strong- Severe erythema, very intense redness. Following visit 6, the Investigators rated tape irritation based on the overall trend observed at visits 2-6. Irritation at visit 2 that resolved by visit 3 was considered none. Skin under occlusion from an adhesive material would be expected to have minimal irritation shortly after the panel is removed. Irritation that persisted or increased in severity beyond visit 3 but resolved by the following visit would have been rated as irritant. An allergic response was considered if irritation persisted beyond visit 3, increased in severity and had symptoms consistent with criteria used to score positive skin reactions according to standard patch testing guidelines established by the International Contact Dermatitis Research Group. |
| Secondary | Chip Irritation | Visit 2 (day 2), visit 3 (day 3-4), visit 4 (day 7-8) visit 5 (day 10-14), visit 6 (day 19-23) with overall assessment by the Investigator following visit 6 | Chip irritation was measured according to the following scale: None- No irritation, Weak- Faint to definite pink erythema, Moderate- Moderate erythema, definite redness, Strong- Severe erythema, very intense redness. Following visit 6, the Investigators rated Chip irritation based on the overall trend observed at visits 2-6. Irritation at visit 2 that resolved by visit 3 was considered none. Skin under occlusion from an adhesive material would be expected to have minimal irritation shortly after the panel is removed. Irritation that persisted or increased in severity beyond visit 3 but resolved by the following visit would have been rated as irritant. An allergic response was considered if irritation persisted beyond visit 3, increased in severity and had symptoms consistent with criteria used to score positive skin reactions according to standard patch testing guidelines established by the International Contact Dermatitis Research Group. |
Source ClinicalTrials.gov
Outcomes4
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 Patch Test Responses | 21 days post patch application | Not all subjects tested all panels. No of subjects testing each panel; Panel 1- 105, Panel 2-111, Panel 3- 104, Panel 4- 109, Panel 5- 106 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Panel Adhesion | Day 2, visit 2 prior to panel removal | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Tape Irritation | Visit 2 (day 2), visit 3 (day 3-4), visit 4 (day 7-8) visit 5 (day 10-14), visit 6 (day 19-23) with overall assessment by the Investigator following visit 6 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Chip Irritation | Visit 2 (day 2), visit 3 (day 3-4), visit 4 (day 7-8) visit 5 (day 10-14), visit 6 (day 19-23) with overall assessment by the Investigator following visit 6 | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group222
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 Patch Test Responses | All Subjects | 0.40 mg/cm2 aluminum chloride / Number Positive | 0 | Participants | |
| Number of Participants With Patch Test Responses | All Subjects | 0.40 mg/cm2 aluminum chloride / Number Negative | 105 | Participants | |
| Number of Participants With Patch Test Responses | All Subjects | 0.40 mg/cm2 aluminum chloride / Number not tested | 16 | Participants | |
| Number of Participants With Patch Test Responses | All Subjects | 0.12 mg/cm2 alumunum chloride / Number Positive | 0 | Participants | |
| Number of Participants With Patch Test Responses | All Subjects | 0.12 mg/cm2 alumunum chloride / Number Negative | 105 | Participants | |
| Number of Participants With Patch Test Responses | All Subjects | 0.12 mg/cm2 alumunum chloride / Number not tested | 16 | Participants | |
| Number of Participants With Patch Test Responses | All Subjects | 0.36 mg/cm2 aluminum chloride / Number Positive | 1 | Participants | |
| Number of Participants With Patch Test Responses | All Subjects | 0.36 mg/cm2 aluminum chloride / Number Negative | 104 | Participants | |
| Number of Participants With Patch Test Responses | All Subjects | 0.36 mg/cm2 aluminum chloride / Number not tested | 16 | Participants | |
| Number of Participants With Patch Test Responses | All Subjects | 0.72 mg/cm2 aluminum chloride / Number Positive | 4 | Participants |
1 to 10 of 222Source ClinicalTrials.gov
See all 222 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | All Subjects | 122 | |
| Overall Study | COMPLETED | All Subjects | 121 | |
| Overall Study | NOT COMPLETED | All Subjects | 1 |
Source ClinicalTrials.gov
Adverse events35
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 | Vertigo | Ear and labyrinth disorders | All Subjects | 1 | 122 | 1 |
| other | Dry eye | Eye disorders | All Subjects | 1 | 122 | 1 |
| other | Hordeolum | Eye disorders | All Subjects | 1 | 122 | 1 |
| other | Abdominal pain, upper | Gastrointestinal disorders | All Subjects | 1 | 122 | 1 |
| other | Glossitis | Gastrointestinal disorders | All Subjects | 1 | 122 | 1 |
| other | Nausea | Gastrointestinal disorders | All Subjects | 2 | 122 | 2 |
| other | Periodontal inflammation | Gastrointestinal disorders | All Subjects | 1 | 122 | 1 |
| other | Toothache | Gastrointestinal disorders | All Subjects | 1 | 122 | 1 |
| other | Vomiting | Gastrointestinal disorders | All Subjects | 1 | 122 | 1 |
| other | Application site erythema | General disorders | All Subjects | 1 | 122 | 1 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Subjects | 0 | 122 |
| Total, other adverse events | All Subjects | 30 | 122 |
| Total, serious adverse events | All Subjects | 1 | 122 |
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/NCT02615249
GET https://conductscience.org/api/trials/v1/NCT02615249/results?page=2