Atopic Dermatitis EczemaPhase 3NCT04500834
Metal Panel Allergen Patch Test Study
A Phase 3 study testing Metal Panel T.R.U.E. Test in people with Atopic Dermatitis Eczema, run by Allerderm at 1 site in United States.
Trial summary
Metal allergen patch test study. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Atopic Dermatitis Eczema
- What is being tested?
- Metal Panel T.R.U.E. Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2022to 31 Mar 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 99 years
- 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 metal allergens (other than nickel or gold), being tested on this study or strong suspicion of metal contact allergy based on results of the Qualification Questionnaire, part 2 Type of Metal Exposure.
- 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 would include 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 (i.e., oral contraceptives, skin patch, vaginal ring, implant, injection, or intrauterine device (IUD), which contains either a hormone or copper); 2) double barrier method (i.e., diaphragm, cervical cap, sponge, condom with spermicide); 3) IUD; 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. Breastfeeding may be resumed upon completion of the study.
- Topical treatment with corticosteroids or other immunosuppressive agents on or near the test area 14 days prior to inclusion through the end of the subject's participation in the study.
- Systemic treatment with corticosteroids (equivalent to > 10 mg prednisone) or other immunosuppressive agents 14 days prior to inclusion through the end of the subject's participation in the study. Inhaled treatments and steroidal nose or eye drops are permitted.
- Treatment with ultraviolet (UV) light (including tanning) during the 3 weeks prior to inclusion through the end of the subject's participation in the study.
- Acute dermatitis outbreak or dermatitis on or near the test area on the back.
- Known or suspected infection of the skin, joints or other site(s) associated with metal exposure
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- Condition 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 6.6.
- Condition such as; psoriasis, dermatitis herpetiformis, mycosis fungoides or cutaneous T-cell lymphoma that may confound the evaluation of allergic contact dermatitis.
- 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
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
DS Research
Louisville, Kentucky, 40241
Haley Jordon, 502-585-9708 ext. 158, hjordon@dsrtrials.com
Joseph Fowler, MD
About this study
Official title: Clinical Evaluation of Metal Panel Allergens: Safety and Efficacy Study
Metal allergen patch test study.
Read the detailed description
A single application of an investigational patch test panel containing 11 hydrogel metal allergens and a corresponding patch test panel containing 11 petrolatum metal allergens will be applied to the upper back of human subjects to test diagnostic efficacy and safety. Patch test panels will be removed after being worn for approximately 48 hours. Study will require 6 visits over the course of 21 days; patch application, patch removal and 4 patch test site evaluation visits at days 4, 7, 14 and 21.
- Conditions
- Atopic Dermatitis Eczema
- Being tested
- Metal Panel T.R.U.E. Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metal Panel T.R.U.E. TestBiological
Diagnostic patch test
| Study group | Role | What they receive |
|---|---|---|
| Positive reactions, Concordance with reference allergen | Experimental | All subjects will be patch tested with 11 experimental and 11 reference allergens. Rates of positive reactions will be evaluated using Cohen's kappa calculation. Receives: Biological: Metal Panel T.R.U.E. Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with positive, negative, irritant or doubtful patch test responses and concordance between hydrogel and petrolatum allergens
Number of patch test responses will be recorded, concordance between hydrogel and petrolatum allergens will be measured
Measured: Days 3-21
Secondary outcomes (5)
Evaluation of panel adhesion at visit 2 prior to panel removal
Number of subjects with excellent, good, poor or detached adhesion at panel removal
Measured: Day 2
Evaluation of subject reported itching associated with test panels at visit 2 following panel removal
Number of subjects with no (none) weak, moderate or strong itching associated with test panels following panel removal
Measured: Day 2
Evaluation of subject reported burning associated with test panels at visit 2 following panel removal.
Number of subjects with no (none) weak, moderate or strong burning associated with test panels following panel removal
Measured: Day 2
Evaluation of tape irritation
Number of subjects with no (none) irritant or allergic tape irritation. Tape irritation is assessed at all visits. Investigator makes overall determination on day 21.
Measured: Day 21
Evaluation of chip irritation
Number of subjects with no (none) irritant or allergic chip irritation. Chip irritation is assessed at all visits. Investigator makes overall determination on day 21.
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start7 Feb 2022
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis EczemaStudies 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 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects will be tested with 11 experimental metal allergens and corresponding metal allergens prepared in petrolatum
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allerderm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Curt Hamann, M.D., Study director, Allerderm (dba SmartPractice)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500834
- Sponsor's protocol ID
- SP20 11MP 301
- Status last verified
- Feb 2023
- First submitted
- 30 Jul 2020
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Metal Panel Allergens: Safety and Efficacy Study
- ClinicalTrials.gov ID
- NCT04500834
- Acronym / sponsor ID
- SP20 11MP 301
- Conditions
- Atopic Dermatitis Eczema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- AllerdermIndustry (pharma, biotech, devices)
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Metal allergen patch test study.
Detailed description
A single application of an investigational patch test panel containing 11 hydrogel metal allergens and a corresponding patch test panel containing 11 petrolatum metal allergens will be applied to the upper back of human subjects to test diagnostic efficacy and safety. Patch test panels will be removed after being worn for approximately 48 hours. Study will require 6 visits over the course of 21 days; patch application, patch removal and 4 patch test site evaluation visits at days 4, 7, 14 and 21.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects will be tested with 11 experimental metal allergens and corresponding metal allergens prepared in petrolatum
| Arm | Type | Receives |
|---|---|---|
| Positive reactions, Concordance with reference allergen | Experimental | Biological: Metal Panel T.R.U.E. TestAll subjects will be patch tested with 11 experimental and 11 reference allergens. Rates of positive reactions will be evaluated using Cohen's kappa calculation. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older.
- Past positive patch test result within the past 10 years to one of the metal allergens (other than nickel or gold), being tested on this study or strong suspicion of metal contact allergy based on results of the Qualification Questionnaire, part 2 Type of Metal Exposure.
- Unable to become pregnant or willing to use an acceptable method of contraception to prevent pregnancy if female of childbearing potential,
- Understands and signs the approved Informed Consent form which is consistent with all institutional, local and national regulations.
Key exclusion criteria (11 listed)
- Breastfeeding or pregnant (as determined by urine pregnancy test) or intending to become pregnant during the course of the study. Breastfeeding may be resumed upon completion of the study.
- Topical treatment with corticosteroids or other immunosuppressive agents on or near the test area 14 days prior to inclusion through the end of the subject's participation in the study.
- Systemic treatment with corticosteroids (equivalent to > 10 mg prednisone) or other immunosuppressive agents 14 days prior to inclusion through the end of the subject's participation in the study. Inhaled treatments and steroidal nose or eye drops are permitted.
- Treatment with ultraviolet (UV) light (including tanning) during the 3 weeks prior to inclusion through the end of the subject's participation in the 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 Panel T.R.U.E. TestDiagnostic patch test | Biological | Positive reactions, Concordance with reference allergen |
Primary outcome
Number of participants with positive, negative, irritant or doubtful patch test responses and concordance between hydrogel and petrolatum allergens
Time frame: Days 3-21
Number of patch test responses will be recorded, concordance between hydrogel and petrolatum allergens will be measured
5 secondary outcomes
Evaluation of panel adhesion at visit 2 prior to panel removal
Time frame: Day 2
Evaluation of subject reported itching associated with test panels at visit 2 following panel removal
Time frame: Day 2
Evaluation of subject reported burning associated with test panels at visit 2 following panel removal.
Time frame: Day 2
Evaluation of tape irritation
Time frame: Day 21
Evaluation of chip irritation
Time frame: Day 21
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data with other researchers.
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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.
Curt Hamann, M.D. study director
Allerderm (dba SmartPractice)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metal Panel T.R.U.E. Test in people with Atopic Dermatitis Eczema, run by Allerderm at 1 site in United States.
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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kathryn Shannon (602-225-0595, kshannon@smarthealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with positive, negative, irritant or doubtful patch test responses and concordance between hydrogel and petrolatum allergens (time frame: Days 3-21). 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 13 Feb 2023.