Contact DermatitisPhase 2NCT02028182
Clinical Evaluation of Lyral® Dose Response Study
A Phase 2 study testing Lyral® in people with Contact Dermatitis, run by Allerderm at 1 site in Denmark.
Trial summary
The purpose of this study is to determine optimal allergen dose as the lowest concentration eliciting positive reactions in 70-90% of subjects. Frequency of positive, negative, doubtful and irritant reactions, and concordance with a corresponding reference allergens will be captured. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Contact Dermatitis
- What is being tested?
- Lyral®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2013to Jun 2013
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females 18 years of age and older.
- Clinical history of contact dermatitis and positive patch test (current or previous) to either Lyral® or Fragrance Mix 2; otherwise in good general health.
- 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 (the same type of birth control for at least 3 months prior to entering the study and continuation of this type of birth control throughout the study); 2) double barrier methods (condom with spermicide or diaphragm with spermicide); 3) intra uterine device; 4) vasectomized partner; or 5) abstinence from sexual intercourse.
- Have read and signed the consent form and are able to fulfill the study requirements and make all required visits.
Who cannot join
- Lactation or pregnancy, determined by urine pregnancy test (UPT) for females of childbearing potential. UPT must be conducted prior to patch placement.
- Treatment with topical corticosteroids on or near the test area during the previous 7 days.
- Treatment with systemic corticosteroids or immunosuppressives during the previous 7 days. (Inhaled treatments are permitted.)
- 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.
- Participation in another clinical study involving an investigational drug, treatment or device currently or within the previous 3 weeks.
- Unable to comply with activity restrictions (e.g., protecting test panels from excess moisture due to showering or vigorous activity).
- Unable or unwilling to comply with multiple return visits.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University of Southern Denmark Institute of Clinical Research
Odense, DK-5000
About this study
Official title: Clinical Evaluation of Hydroxyisohexyl 3-cyclohexene Carboxaldehyde (Lyral®) Dose Response Study
The purpose of this study is to determine optimal allergen dose as the lowest concentration eliciting positive reactions in 70-90% of subjects. Frequency of positive, negative, doubtful and irritant reactions, and concordance with a corresponding reference allergens will be captured.
Read the detailed description
This is a single-center, randomized study to compare the diagnostic performance and safety of ascending doses (0.10 mg/cm², 0.20 mg/cm² and 0.40 mg/cm²) of hydroxyisohexyl 3-cyclohexene carboxaldehyde (Lyral®) in 20 adult subjects with a past positive patch test to Lyral® or Fragrance Mix 2.
- Conditions
- Contact Dermatitis
- Being tested
- Lyral®
- Keywords
- Patch Test, Allergy Testing, Contact dermatitis, Lyral allergen, Fragrance Mix allergen
- Medical subject headings
- Dermatitis, Contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lyral®Biological
Also called Lyral Allergen Panel (experimental)
Alergen panel containing ascending doses of Lyral (0.10 mg/cm^2, 0.20 mg/cm^2 and 0.40 mg/cm^2) and negative control
| Study group | Role | What they receive |
|---|---|---|
| Positive reactions, Concordance with reference allergen | Experimental | Subjects were patch tested with an experimental allergen panel containing ascending doses of Lyral (0.10 mg/cm2, 0.20 mg/cm2 and 0.40 mg/cm2) and a negative control. A second panel containing 20 mg of 5% Lyral in petrolatum was applied for evaluation of concordance. The panels were worn for approximately 48 hours. Skin reactions were assessed at 3, 4 and 21 days following application. Receives: Biological: Lyral® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Positive Patch Test Responses
Subjects were patch tested with one experimental T.R.U.E. Test allergen panel containing 0.40 mg/cm^2, 0.20 mg/cm^2, and 0.10 mg/cm^2 of Lyral® and a negative control and a second panel containing the marketed reference allergen (20 mg of Lyral® 5%, in petrolatum). The panels were worn for approximately 48 hours. Skin reactions were assessed at 3, 4 and 21 days following application. Negative responses are graded no response, doubtful response (faint erythema, no infiltration), or irritant response (patchy erythema, no infiltration). Positive responses are graded 1+ (erythema, infiltration, discrete papules), 2+ (erythema infiltration, papules, discrete vesicles), or 3+ (coalescing vesicles, bullous reaction)
Measured: Patch test sites were evaluated at day 3 or 4, day 7 and day 21 following application. Results were assessed by the Investigator following the day 21 visit.
Secondary outcomes (2)
Number of Subjects With Tape Irritation, Itching and Burning
Tape irritation is graded on a 4 point scale: None (no tape irritation), Weak (faint to definite pink), Moderate (moderate erythema, definite redness) and Strong (severe erythema, very intense redness). Percentage of response will include weak, moderate and strong reactions.
Itching and Burning are graded on a 4 point scale: None (no discomfort), Weak (minimal discomfort), Moderate (definite discomfort) and Strong (significantly bothersome, possible interference with sleep or daily activity). Percentage of response will include weak, moderate and strong responses.
Measured: Day 2: 48 hours after application
Number of Subjects Who Exhibit Late or Persistent Reactions
Late reactions initially occur at 7-21 days after application of the panels Persistent reactions appear at Day 2-4 and persist through Day 7-21
Measured: Days 2-21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startFeb 2013
- Primary completionJun 2013
- Study completionJun 2013
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 Contact DermatitisStudies 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allerderm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Evy Paulsen, Md, PhD, Principal investigator, Department of Dermatology and Allergy Centre Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02028182
- Sponsor's protocol ID
- 12 1PL 201
- Status last verified
- Jan 2014
- First submitted
- 2 Jan 2014
- Last updated
- 28 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Hydroxyisohexyl 3-cyclohexene Carboxaldehyde (Lyral®) Dose Response Study
- ClinicalTrials.gov ID
- NCT02028182
- Acronym / sponsor ID
- 12 1PL 201
- Conditions
- Contact Dermatitis
- Keywords
- Patch Test, Allergy Testing, Contact dermatitis, Lyral allergen, Fragrance Mix allergen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- AllerdermIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 7 Jan 2014 (estimated)
- Results
- Posted 24 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine optimal allergen dose as the lowest concentration eliciting positive reactions in 70-90% of subjects. Frequency of positive, negative, doubtful and irritant reactions, and concordance with a corresponding reference allergens will be captured.
Detailed description
This is a single-center, randomized study to compare the diagnostic performance and safety of ascending doses (0.10 mg/cm², 0.20 mg/cm² and 0.40 mg/cm²) of hydroxyisohexyl 3-cyclohexene carboxaldehyde (Lyral®) in 20 adult subjects with a past positive patch test to Lyral® or Fragrance Mix 2.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Positive reactions, Concordance with reference allergen | Experimental | Biological: Lyral®Subjects were patch tested with an experimental allergen panel containing ascending doses of Lyral (0.10 mg/cm2, 0.20 mg/cm2 and 0.40 mg/cm2) and a negative control. A second panel containing 20 mg of 5% Lyral in petrolatum was applied for evaluation of concordance. The panels were worn for approximately 48 hours. Skin reactions were assessed at 3, 4 and 21 days following application. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females 18 years of age and older.
- Clinical history of contact dermatitis and positive patch test (current or previous) to either Lyral® or Fragrance Mix 2; otherwise in good general health.
- 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 (the same type of birth control for at least 3 months prior to entering the study and continuation of this type of birth control throughout the study); 2) double barrier methods (condom with spermicide or diaphragm with spermicide); 3) intra uterine device; 4) vasectomized partner; or 5) abstinence from sexual intercourse.
- Have read and signed the consent form and are able to fulfill the study requirements and make all required visits.
Key exclusion criteria (8 listed)
- Lactation or pregnancy, determined by urine pregnancy test (UPT) for females of childbearing potential. UPT must be conducted prior to patch placement.
- Treatment with topical corticosteroids on or near the test area during the previous 7 days.
- Treatment with systemic corticosteroids or immunosuppressives during the previous 7 days. (Inhaled treatments are permitted.)
- 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.
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 |
|---|---|---|
| Lyral®Also: Lyral Allergen Panel (experimental)Alergen panel containing ascending doses of Lyral (0.10 mg/cm^2, 0.20 mg/cm^2 and 0.40 mg/cm^2) and negative control | Biological | Positive reactions, Concordance with reference allergen |
Primary outcome
Number of Participants With Positive Patch Test Responses
Time frame: Patch test sites were evaluated at day 3 or 4, day 7 and day 21 following application. Results were assessed by the Investigator following the day 21 visit.
Subjects were patch tested with one experimental T.R.U.E. Test allergen panel containing 0.40 mg/cm^2, 0.20 mg/cm^2, and 0.10 mg/cm^2 of Lyral® and a negative control and a second panel containing the marketed reference allergen (20 mg of Lyral® 5%, in petrolatum). The panels were worn for approximately 48 hours. Skin reactions were assessed at 3, 4 and 21 days following application. Negative responses are graded no response, doubtful response (faint erythema, no infiltration), or irritant response (patchy erythema, no infiltration). Positive responses are graded 1+ (erythema, infiltration, discrete papules), 2+ (erythema infiltration, papules, discrete vesicles), or 3+ (coalescing vesicles, bullous reaction)
2 secondary outcomes
Number of Subjects With Tape Irritation, Itching and Burning
Time frame: Day 2: 48 hours after application
Number of Subjects Who Exhibit Late or Persistent Reactions
Time frame: Days 2-21
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- 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.
Evy Paulsen, Md, PhD principal investigator
Department of Dermatology and Allergy Centre Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lyral® in people with Contact Dermatitis, run by Allerderm at 1 site in Denmark.
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 5 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 28 Jul 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 Denmark. 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 24 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 Positive Patch Test Responses (time frame: Patch test sites were evaluated at day 3 or 4, day 7 and day 21 following application. Results were assessed by the Investigator following the day 21 visit.). 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 28 Jul 2023.