Allergic Contact DermatitisEarly Phase 1NCT03945760
Efficacy of Baricitinib In Treatment of Delayed-Type Hypersensitivity Versus Irritant Skin Reactions in Healthy Adult Male Subjects
A Early Phase 1 study testing Baricitinib in people with Allergic Contact Dermatitis, run by Wright State Physicians at 1 site in United States.
Trial summary
The treatment of allergic contact dermatitis (ACD) can be unsatisfactory, and that other skin diseases such as atopic dermatitis have an increased likelihood of ACD, improved systemic treatments are needed. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Allergic Contact Dermatitis
- What is being tested?
- Baricitinib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2020to 16 Oct 2023
- Phase
- Early Phase 1
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males 18-40 years of age at the time of signing the informed consent document
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted
- Able to adhere to the study visit schedule and other protocol requirements
- Must be in good health as judged by the Investigator, based on medical history and physical examination, and no laboratory abnormalities
Who cannot join
- Any known severe allergies to yeast products
- Currently active skin diseases such as psoriasis, atopic dermatitis, allergic contact dermatitis or irritant contact dermatitis
- Inability to understand informed consent
- Any medical condition that the investigator feels would interfere with study
- Any abnormalities on physical exam or screening laboratory studies (to progress to Part II)
- Agree to discontinue use of prohibited medications at least 4 weeks prior to screening:
Show all 9Show fewer
- topical corticosteroids, oral or injectable systemic steroids, systemic immunomodulators (cyclosporine, methotrexate, etc.), oral or topical antihistamines
- Positive reaction to tuberculin test (PPD) or negative control
- Negative reaction to initial skin testing for Candida, Trichophyton, or Sodium Laurel Sulfate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigator Initiated Study to Evaluate the Efficacy of Baricitinib In Treatment of Delayed-Type Hypersensitivity Versus Irritant Skin Reactions In Healthy Adult Male Subjects
The treatment of allergic contact dermatitis (ACD) can be unsatisfactory, and that other skin diseases such as atopic dermatitis have an increased likelihood of ACD, improved systemic treatments are needed.
This research study explores the effectiveness of Baricitinib in treating Delayed-Type Hypersensitivity (allergic) versus Irritant Skin reactions. Subjects for this study need to be healthy males between the ages of 18 and 40. This study will evaluate this by injecting antigens as well as applying them on top of the skin to the forearm then measure the effects of Baricitinib by skin and blood testing.
- Conditions
- Allergic Contact Dermatitis
- Being tested
- Baricitinib, Placebo
- Medical subject headings
- Dermatitis, Allergic Contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaricitinibDrug
Baricitinib 2 mg
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Subjects Taking Baricitinib 2 mg | Experimental | Subjects will be taking Baricitinib 2mg Receives: Drug: Baricitinib |
| Subjects Taking Placebo | Placebo comparator | Subjects will be taking placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with reduced skin inflammation associated with Delayed-Type Hypersensitivity (DTH) versus irritant skin reactions by erythema measurement.
Investigator will assess the skin inflammation reduction as measured by erythema associated with DTH versus irritant skin reactions.
Measured: Day 28
Number of participants with reduced skin inflammation associated with Delayed-Type Hypersensitivity (DTH) versus irritant skin reactions by measurement of reaction size.
Investigator will assess the skin inflammation reduction as measured by reaction size associated with DTH versus irritant skin reactions.
Measured: Day 28
Number of participants with reduced skin inflammation associated with Delayed-Type Hypersensitivity (DTH) versus irritant skin reactions by pro-inflammatory cytokine profile.
Investigator will assess the skin inflammation reduction as measured by pro-inflammatory cytokine profile associated with DTH versus irritant skin reactions.
Measured: Day 28
Secondary outcomes (1)
Number of participants with reduced pruritus associated with DTH versus irritant skin reactions.
Investigator will assess pruritus reduction associated with DTH versus irritant skin reactions by a daily itch rating scale questionnaire.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start14 Sep 2020
- Primary completion16 Oct 2023
- Study completion16 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wright State Physicians
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey B Travers, MD, PhD, Principal investigator, Wright State Physicians
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945760
- Sponsor's protocol ID
- I4V-US-O007
- Status last verified
- Dec 2023
- First submitted
- 26 Apr 2019
- Last updated
- 5 Dec 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator Initiated Study to Evaluate the Efficacy of Baricitinib In Treatment of Delayed-Type Hypersensitivity Versus Irritant Skin Reactions In Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT03945760
- Acronym / sponsor ID
- I4V-US-O007
- Conditions
- Allergic Contact Dermatitis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Wright State PhysiciansUniversity, hospital or other
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 16 Oct 2023 (actual)
- Study completion
- 16 Oct 2023 (actual)
- First posted
- 10 May 2019 (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.
The treatment of allergic contact dermatitis (ACD) can be unsatisfactory, and that other skin diseases such as atopic dermatitis have an increased likelihood of ACD, improved systemic treatments are needed.
This research study explores the effectiveness of Baricitinib in treating Delayed-Type Hypersensitivity (allergic) versus Irritant Skin reactions. Subjects for this study need to be healthy males between the ages of 18 and 40. This study will evaluate this by injecting antigens as well as applying them on top of the skin to the forearm then measure the effects of Baricitinib by skin and blood testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects Taking Baricitinib 2 mg | Experimental | Drug: BaricitinibSubjects will be taking Baricitinib 2mg |
| Subjects Taking Placebo | Placebo comparator | Drug: PlaceboSubjects will be taking placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males 18-40 years of age at the time of signing the informed consent document
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted
- Able to adhere to the study visit schedule and other protocol requirements
- Must be in good health as judged by the Investigator, based on medical history and physical examination, and no laboratory abnormalities
Key exclusion criteria (9 listed)
- Any known severe allergies to yeast products
- Currently active skin diseases such as psoriasis, atopic dermatitis, allergic contact dermatitis or irritant contact dermatitis
- Inability to understand informed consent
- Any medical condition that the investigator feels would interfere with study
- Any abnormalities on physical exam or screening laboratory studies (to progress to Part II)
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 |
|---|---|---|
| BaricitinibBaricitinib 2 mg | Drug | Subjects Taking Baricitinib 2 mg |
| PlaceboPlacebo | Drug | Subjects Taking Placebo |
Primary outcome
Number of participants with reduced skin inflammation associated with Delayed-Type Hypersensitivity (DTH) versus irritant skin reactions by erythema measurement.
Time frame: Day 28
Investigator will assess the skin inflammation reduction as measured by erythema associated with DTH versus irritant skin reactions.
Number of participants with reduced skin inflammation associated with Delayed-Type Hypersensitivity (DTH) versus irritant skin reactions by measurement of reaction size.
Time frame: Day 28
Investigator will assess the skin inflammation reduction as measured by reaction size associated with DTH versus irritant skin reactions.
Number of participants with reduced skin inflammation associated with Delayed-Type Hypersensitivity (DTH) versus irritant skin reactions by pro-inflammatory cytokine profile.
Time frame: Day 28
Investigator will assess the skin inflammation reduction as measured by pro-inflammatory cytokine profile associated with DTH versus irritant skin reactions.
1 secondary outcome
Number of participants with reduced pruritus associated with DTH versus irritant skin reactions.
Time frame: Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
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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.
Jeffrey B Travers, MD, PhD principal investigator
Wright State Physicians
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Baricitinib in people with Allergic Contact Dermatitis, run by Wright State Physicians 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 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 5 Dec 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 reduced skin inflammation associated with Delayed-Type Hypersensitivity (DTH) versus irritant skin reactions by erythema measurement. (time frame: Day 28). The study lists 3 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 5 Dec 2023; AzTrials last refreshed its copy on 8 Nov 2026.