Dermatitis, ContactPhase 2NCT00612768
Clinical Evaluation of T.R.U.E. TEST® Fragrance Mix and Thimerosal Allergens:Bioequivalence of PVP Formulations
A Phase 2 study testing TRUE Test allergens Fragrance Mix and Thimerosol in people with Dermatitis, Contact, run by Allerderm at 4 sites in United States.
Trial summary
Open, prospective, multi-center study to evaluate the bioequivalence of povidone (PVP) formulations of 2 T.R.U.E. TEST allergens: fragrance mix and thimerosal. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dermatitis, Contact
- What is being tested?
- TRUE Test allergens Fragrance Mix and Thimerosol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2008to Oct 2009
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current or previous symptoms and/or history consistent with allergic contact dermatitis, and positive patch test (within the past 5 years) to fragrance mix AND/OR thimerosal.
- All subjects must be adults (18 years of age or older) and otherwise in good health.
- Pre-menopausal female subjects must consent to a urine pregnancy test; results must be negative for study inclusion.
- Informed consent must be signed and understood by each subject, and consistent with all institutional, local and national regulations.
Who cannot join
- Subjects unable to meet inclusion requirements.
- Women who are breastfeeding or pregnant.
- Topical treatment during the last 7 days with corticosteroids or other immunosuppressive agents on or near the test area.
- Systemic treatment during the last 7 days with corticosteroids (equivalent to > 10 mg prednisone) or other immunosuppressive agents.
- Treatment with ultraviolet (UV) light (including tanning) during the previous 3 weeks.
- Acute dermatitis outbreak or dermatitis on or near the test area on the back.
- Subjects unable 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).
- Subject participation in clinical trials of investigational drugs, treatments, or devices, other than T.R.U.E. TEST, during this study or 3 weeks prior to inclusion in this study.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
River City Dermatology
Little Rock, Arkansas, 72205
Dermatology Specialists PSC
Louisville, Kentucky, 40202-1864
Winthrop University Hospital
Mineola, New York, 11501
American Dermatology Associates
Shawnee Mission, Kansas, 66216
About this study
Official title: Clinical Evaluation of T.R.U.E. TEST® Fragrance Mix and Thimerosal Allergens: Bioequivalence of Polyvinylpyrrolidone (PVP) Formulations
Open, prospective, multi-center study to evaluate the bioequivalence of povidone (PVP) formulations of 2 T.R.U.E. TEST allergens: fragrance mix and thimerosal.
Read the detailed description
Bioequivalence will be determined in 40 adult subjects (20 per allergen), who have a clinical history of contact dermatitis and have tested positive to fragrance mix or thimerosal.
- Conditions
- Dermatitis, Contact
- Being tested
- TRUE Test allergens Fragrance Mix and Thimerosol
- Keywords
- Bioequivalence, Thimerosal, Fragrance Mix, PVP formulation, Contact dermatitis
- Medical subject headings
- Dermatitis, Contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRUE Test allergens Fragrance Mix and ThimerosolBiological
Also called T.R.U.E. TEST Skin Patch Test
- Thimerosal, 0.008 mg/cm2 in hydroxypropylcellulose
- Thimerosal, 0.008 mg/cm2 in polyvinylpyrrolidone
- Fragrance mix, 0.43 mg/cm2 in hydroxypropylcellulose with β-cyclodextrin
- Fragrance mix, 0.43 mg/cm2 in polyvinylpyrrolidone with β-cyclodextrin
Patches are placed at day one and removed 48 hours. The duration of the study lasts 21 days. However, the subject is only exposed the the study allergen for 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| T.R.U.E. Test allergens Fragrance Mix and Thimerosol | Experimental | Concordance (agreement) between positive patch reactions to
1. fragrance mix (0.43 mg/cm2) in polyvinylpyrrolidone (PVP) vs fragrance mix (0.43 mg/cm2) in hydroxypropylcellulose (HPC)
2. thimerosol (0.008 mg/cm2) in polyvinylpyrrolidone (PVP) vs thimerosol (0.008 mg/cm2) in hydroxypropylcellulose (HPC)
3. fragrance mix T.R.U.E. Test allergen vs fragrance mix reference allergen (petrolatum)
4. thimerosol T.R.U.E. Test allergen vs thimerosol reference allergen (petrolatum)
will be measured Receives: Biological: TRUE Test allergens Fragrance Mix and Thimerosol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of Bioequivalence: Concordance
Percent agreement between T.R.U.E. Test allergen in PVP vs HPC is based on a positive test response during at least one post application visit
Measured: Up to 21 days
Agreement Between TRUE Test Allergen and Reference Allergen
Sensitivity: Agreement between positive results for the test and reference allergen Specificity: Agreement between negative results for the test and reference allergen
Measured: Up to 21 days
Secondary outcomes (2)
Irritation, Adhesion, Itching/Burning
Frequency of tape-induced irritation at the test site, incomplete panel adhesion and subject-reported sensations of itching or burning.
Measured: Visit 2: 48 hours after patch application
Frequency of Late and Persistent Reactions
Late reactions occur 7-10 days after patch application Persistent reactions initially occur at 2-4 days after application and persist through 7-21 days after application
Measured: Day 2 (48 hours after application) through Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2008
- Study completionOct 2009
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, ContactStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allerderm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Fowler, MD, Principal investigator, Dermatology Specialists PSCLuz Fonacier, MD, Principal investigator, Winthrop University HospitalDonald V. Belsito, MD, Principal investigator, American Dermatology AssociatesJerri Hoskyn, MD, Principal investigator, River City Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00612768
- Sponsor's protocol ID
- Mekos 07 2P1/2 401
- Other IDs
- 20071738
- Status last verified
- Apr 2018
- First submitted
- 30 Jan 2008
- Last updated
- 9 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of T.R.U.E. TEST® Fragrance Mix and Thimerosal Allergens: Bioequivalence of Polyvinylpyrrolidone (PVP) Formulations
- ClinicalTrials.gov ID
- NCT00612768
- Acronym / sponsor ID
- Mekos 07 2P1/2 401
- Conditions
- Dermatitis, Contact
- Keywords
- Bioequivalence, Thimerosal, Fragrance Mix, PVP formulation, Contact dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- AllerdermIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 12 Feb 2008 (estimated)
- Results
- Posted 9 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open, prospective, multi-center study to evaluate the bioequivalence of povidone (PVP) formulations of 2 T.R.U.E. TEST allergens: fragrance mix and thimerosal.
Detailed description
Bioequivalence will be determined in 40 adult subjects (20 per allergen), who have a clinical history of contact dermatitis and have tested positive to fragrance mix or thimerosal.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T.R.U.E. Test allergens Fragrance Mix and Thimerosol | Experimental | Biological: TRUE Test allergens Fragrance Mix and ThimerosolConcordance (agreement) between positive patch reactions to 1. fragrance mix (0.43 mg/cm2) in polyvinylpyrrolidone (PVP) vs fragrance mix (0.43 mg/cm2) in hydroxypropylcellulose (HPC) 2. thimerosol (0.008 mg/cm2) in polyvinylpyrrolidone (PVP) vs thimerosol (0.008 mg/cm2) in hydroxypropylcellulose (HPC) 3. fragrance mix T.R.U.E. Test allergen vs fragrance mix reference allergen (petrolatum) 4. thimerosol T.R.U.E. Test allergen vs thimerosol reference allergen (petrolatum) will be measured |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Current or previous symptoms and/or history consistent with allergic contact dermatitis, and positive patch test (within the past 5 years) to fragrance mix AND/OR thimerosal.
- All subjects must be adults (18 years of age or older) and otherwise in good health.
- Pre-menopausal female subjects must consent to a urine pregnancy test; results must be negative for study inclusion.
- Informed consent must be signed and understood by each subject, and consistent with all institutional, local and national regulations.
Key exclusion criteria (8 listed)
- Subjects unable to meet inclusion requirements.
- Women who are breastfeeding or pregnant.
- Topical treatment during the last 7 days with corticosteroids or other immunosuppressive agents on or near the test area.
- Systemic treatment during the last 7 days with corticosteroids (equivalent to > 10 mg prednisone) or other immunosuppressive agents.
- Treatment with ultraviolet (UV) light (including tanning) during the previous 3 weeks.
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 |
|---|---|---|
| TRUE Test allergens Fragrance Mix and ThimerosolAlso: T.R.U.E. TEST Skin Patch Test* Thimerosal, 0.008 mg/cm2 in hydroxypropylcellulose * Thimerosal, 0.008 mg/cm2 in polyvinylpyrrolidone * Fragrance mix, 0.43 mg/cm2 in hydroxypropylcellulose with β-cyclodextrin * Fragrance mix, 0.43 mg/cm2 in polyvinylpyrrolidone with β-cyclodextrin Patches are placed at day one and removed 48 hours. The duration of the study lasts 21 days. However, the subject is only exposed the the study allergen for 48 hours. | Biological | T.R.U.E. Test allergens Fragrance Mix and Thimerosol |
Primary outcome
Analysis of Bioequivalence: Concordance
Time frame: Up to 21 days
Percent agreement between T.R.U.E. Test allergen in PVP vs HPC is based on a positive test response during at least one post application visit
Agreement Between TRUE Test Allergen and Reference Allergen
Time frame: Up to 21 days
Sensitivity: Agreement between positive results for the test and reference allergen Specificity: Agreement between negative results for the test and reference allergen
2 secondary outcomes
Irritation, Adhesion, Itching/Burning
Time frame: Visit 2: 48 hours after patch application
Frequency of Late and Persistent Reactions
Time frame: Day 2 (48 hours after application) through Day 21
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Joseph Fowler, MD principal investigator
Dermatology Specialists PSC
Luz Fonacier, MD principal investigator
Winthrop University Hospital
Donald V. Belsito, MD principal investigator
American Dermatology Associates
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TRUE Test allergens Fragrance Mix and Thimerosol in people with Dermatitis, Contact, run by Allerderm at 4 sites 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 4 inclusion and 8 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 9 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 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 9 Apr 2018). 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?
Analysis of Bioequivalence: Concordance (time frame: Up to 21 days). The study lists 2 primary outcomes in all. 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 9 Apr 2018.