Dermatitis, EczematousPhase 2NCT02615249
Clinical Evaluation of Metal Panel Allergens: Dose Response Study
A Phase 2 study testing Metal Allergen Epicutaneous Patch in people with Dermatitis, Eczematous, run by Allerderm at 8 sites in 6 countries.
Trial summary
48-hour application of metal allergen patches to test for potential allergic responses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatitis, Eczematous
- What is being tested?
- Metal Allergen Epicutaneous Patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 8 sitesin 6 countries
- Study dates
- 5 Dec 2016to 15 Jul 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older.
- Past positive patch test result within the past 10 years (to one of the dilution series metals being tested on this study) or strong suspicion of metal contact allergy based on results of the Qualification Questionnaire.
- Unable to become pregnant or willing to use an acceptable method of contraception to prevent pregnancy if female of childbearing potential; (Inability to become pregnant includes all male subjects and female subjects who are postmenopausal for at least 1 year, or surgically sterile- have had a hysterectomy, bilateral ovariectomy, uterine ablation or bilateral tubal ligation. Acceptable methods of contraception include: 1) systemic birth control; 2) double barrier method; 3) intrauterine device; 4) vasectomized partner; or 5) abstinence from sexual intercourse. Subject must agree to use acceptable contraception for the duration of the entire study.)
- Understands and signs the approved Informed Consent form which is consistent with all institutional, local and national regulations.
Who cannot join
- Breastfeeding or pregnant (as determined by urine pregnancy test) or intending to become pregnant during the course of the study.
- Topical treatment with corticosteroids or other immunosuppressive agents on or near the test area during the 14 days prior to inclusion in this study.
- Systemic treatment with corticosteroids (equivalent to > 10 mg prednisone) or other immunosuppressive agents during the 14 days prior to inclusion in this study. Inhaled treatments are permitted. NOTE: Steroidal nose or eye drops are permitted.
- Treatment with ultraviolet (UV) light (including tanning) during the 3 weeks prior to inclusion in this study.
- Acute dermatitis outbreak or dermatitis on or near the test area on the back.
- Conditions such as; fibromyalgia, chronic fatigue, depression, cognitive impairment, flu-like symptoms, diarrhea and/or headache without at least one of the symptoms related to metal exposure listed in Section 10.1 under physical examination
Show all 9Show fewer
- Inability to comply with patch test study requirements including multiple return visits and activity restrictions (e.g., protecting test panels from excess moisture due to showering or vigorous activity).
- Participation in a clinical trial of an investigational drug, treatment or device during this study or 3 weeks prior to inclusion in this study.
- An opinion of the Investigator that deems the potential subject to be non-compliant, unable to return for study visits or complete the study as detailed in the protocol.
Trial locations and contacts
8 sites in 6 countries.
8 sites in 6 countries
Japan3 sites
Fujita Health University School of Medicine
Aichi, 470-1192
Kyoto Prefectural University of Medicine
Kyoto, 602-8566
Tokushima University Graduate School
Tokushima, 770-8504
United States1 site
National Jewish Health, University of Colorado Denver
Denver, Colorado, 80206
Switzerland1 site
University Hospital Basel Allergology Unit
Basel, CH-4031
About this study
Official title: Clinical Evaluation of Metal Panel Allergens: Aluminum, Copper, Manganese, Molybdenum, Tin, Titanium, Vanadium and Zinc Dose Response Study
48-hour application of metal allergen patches to test for potential allergic responses.
Read the detailed description
A 48-hour application (approximate) of investigational allergen panels, excipient controls and corresponding reference allergens will be applied to the skin of human subjects to test for potential positive allergic responses. Test sites will be evaluated at 3-4, 7-8, 10-14 and 19-23 days after application. Ascending allergen dosages will be randomized within each panel into three different configurations which will be randomly assigned to subjects as they enter the study. The investigators and subjects will be aware of the allergens and the patch test doses but will not be aware of the location of individual allergens within each panel.
- Conditions
- Dermatitis, Eczematous
- Being tested
- Metal Allergen Epicutaneous Patch
- Medical subject headings
- Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metal Allergen Epicutaneous PatchBiological
48 hour application of metal allergen patch to diagnose contact dermatitis
| Study group | Role | What they receive |
|---|---|---|
| Metal Allergen Epicutaneous Patch | Experimental | 8 allergens were tested. Not all subjects tested each allergen. Section reports number of subjects with positive responses to each allergen. Receives: Biological: Metal Allergen Epicutaneous Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Patch Test Responses
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.
Measured: 21 days post patch application
Secondary outcomes (3)
Number of Subjects With Panel Adhesion
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
Measured: Day 2, visit 2 prior to panel removal
Tape Irritation
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.
Measured: 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
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study start5 Dec 2016
- Primary completion15 Jul 2019
- Study completion15 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dermatitis, EczematousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allerderm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patricia L Norris, MD, Principal investigator, Oregon Health & Science University, Portland USAKarin Pacheco, MD, Principal investigator, National Jewish Health School of Medicine, Colorado USAAndreas Bircher, MD, Principal investigator, University Hospital, Basel, SwitzerlandPaolo Pigatto, MD, Principal investigator, University of Milano, ItalyThomas Rustemeyer, MD, PhD, Principal investigator, VU University Medical Center, NetherlandsPeter Thomas, MD, Principal investigator, Ludwig-Maximilians-Universität München, GermanyMaki Hosoki, DDS, PhD, Principal investigator, Tokushima University Graduate School, JapanRisa Tamagawa-Mineoka, MD, Principal investigator, Kyoto Prefectural University of Medicine, Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02615249
- Sponsor's protocol ID
- SP148MP201
- Status last verified
- Apr 2020
- First submitted
- 23 Nov 2015
- Last updated
- 25 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Metal Panel Allergens: Aluminum, Copper, Manganese, Molybdenum, Tin, Titanium, Vanadium and Zinc Dose Response Study
- ClinicalTrials.gov ID
- NCT02615249
- Acronym / sponsor ID
- SP148MP201
- Conditions
- Dermatitis, Eczematous
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- AllerdermIndustry (pharma, biotech, devices)
- Study start
- 5 Dec 2016 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 26 Nov 2015 (estimated)
- Results
- Posted 11 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
48-hour application of metal allergen patches to test for potential allergic responses.
Detailed description
A 48-hour application (approximate) of investigational allergen panels, excipient controls and corresponding reference allergens will be applied to the skin of human subjects to test for potential positive allergic responses. Test sites will be evaluated at 3-4, 7-8, 10-14 and 19-23 days after application. Ascending allergen dosages will be randomized within each panel into three different configurations which will be randomly assigned to subjects as they enter the study. The investigators and subjects will be aware of the allergens and the patch test doses but will not be aware of the location of individual allergens within each panel.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metal Allergen Epicutaneous Patch | Experimental | Biological: Metal Allergen Epicutaneous Patch8 allergens were tested. Not all subjects tested each allergen. Section reports number of subjects with positive responses to each allergen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older.
- Past positive patch test result within the past 10 years (to one of the dilution series metals being tested on this study) or strong suspicion of metal contact allergy based on results of the Qualification Questionnaire.
- Unable to become pregnant or willing to use an acceptable method of contraception to prevent pregnancy if female of childbearing potential; (Inability to become pregnant includes all male subjects and female subjects who are postmenopausal for at least 1 year, or surgically sterile- have had a hysterectomy, bilateral ovariectomy, uterine ablation or bilateral tubal ligation. Acceptable methods of contraception include: 1) systemic birth control; 2) double barrier method; 3) intrauterine device; 4) vasectomized partner; or 5) abstinence from sexual intercourse. Subject must agree to use acceptable contraception for the duration of the entire study.)
- Understands and signs the approved Informed Consent form which is consistent with all institutional, local and national regulations.
Key exclusion criteria (9 listed)
- Breastfeeding or pregnant (as determined by urine pregnancy test) or intending to become pregnant during the course of the study.
- Topical treatment with corticosteroids or other immunosuppressive agents on or near the test area during the 14 days prior to inclusion in this study.
- Systemic treatment with corticosteroids (equivalent to > 10 mg prednisone) or other immunosuppressive agents during the 14 days prior to inclusion in this study. Inhaled treatments are permitted. NOTE: Steroidal nose or eye drops are permitted.
- Treatment with ultraviolet (UV) light (including tanning) during the 3 weeks prior to inclusion in this study.
- Acute dermatitis outbreak or dermatitis on or near the test area on the back.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metal Allergen Epicutaneous Patch48 hour application of metal allergen patch to diagnose contact dermatitis | Biological | Metal Allergen Epicutaneous Patch |
Primary outcome
Number of Participants With Patch Test Responses
Time frame: 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.
3 secondary outcomes
Number of Subjects With Panel Adhesion
Time frame: Day 2, visit 2 prior to panel removal
Tape Irritation
Time frame: 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
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia L Norris, MD principal investigator
Oregon Health & Science University, Portland USA
Karin Pacheco, MD principal investigator
National Jewish Health School of Medicine, Colorado USA
Andreas Bircher, MD principal investigator
University Hospital, Basel, Switzerland
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metal Allergen Epicutaneous Patch in people with Dermatitis, Eczematous, run by Allerderm at 8 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Japan, United States, Germany, Italy, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Patch Test Responses (time frame: 21 days post patch application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2020.