Contact DermatitisNCT04772482
Study on Hypoallergenic Hair Dye
An observational study of Contact Dermatitis and Allergy; Dermatitis, run by University of Minnesota at 1 site in United States.
Trial summary
Permanent hair dyes are commonly used in over the counter direct to consumer products and within hair salons. Allergy, also known as contact dermatitis, to hair dye is a well known phenomenon. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Contact Dermatitis, Allergy; Dermatitis, Dermatitis
- What is being tested?
- Sensitivity Patch Testing
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 13 May 2022
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with sensitivity to PPD and/or PTD
Who may be able to join
- Proven Diagnosis of PPD and/or PTD sensitization (patch tests and clinically relevant eczematous reactions to hair dye)
Who cannot join
- Use of oral immunosuppressive, anti-inflammatory and chemotherapy medications, particularly corticosteroids for at least 1 month before testing.
- Immunocompromised patient (e.g. Cancer, Diabetes mellitus, medication, Immunodeficiency, radiation therapy)
- History of acute hepatitis, chronic liver disease or end stage liver disease.
- History of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome.
- Use of illicit drugs within the past 6 months prior to study start and/or opioid use disorder.
- Pregnancy as established by questionnaire
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55404
About this study
Official title: Testing of Alternatives for Dark Hair Dyes in Patients With Proven Sensitization to Para-Phenylenediamine
Permanent hair dyes are commonly used in over the counter direct to consumer products and within hair salons. Allergy, also known as contact dermatitis, to hair dye is a well known phenomenon. Herein, we seek to decrease the risks of allergy to hair dyes by testing a novel version of p-phenylenediamine (PPD) with less allergy potential.
Read the detailed description
For patients with PPD sensitizations, it is important to find alternatives for dark hair dyes. P-toluenediamine (PTD) and potentially also 2-methoxyethyl p-phenylenediamine (ME-PPD) show cross-reactivity with PPD and therefore we want to prove that our new compounds PPD-6 and PPD-7 show no or significantly reduced cross-reactions with PPD and do not induce relevant allergic reactions in patients with proven PPD sensitizations.
Our specific aims for this study are the following:
A1) To show that PPD 6 and PPD 7 have reduced or optimally no reaction in standard patch tests in patients with proven allergy to PPD A2) To compare the sensitization pattern to other possible commercially available alternatives for hair dye, such as ME-PPD and PTD A3) To evaluate and rule out any possible non-specific irritant reaction of PPD-6 and PPD-7 in these patch tests (i.e. confirm in-vitro safety profile in-vivo)
- Conditions
- Contact Dermatitis, Allergy; Dermatitis, Dermatitis
- Being tested
- Sensitivity Patch Testing
- Medical subject headings
- Dermatitis, Contact, Dermatitis, Atopic, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensitivity Patch TestingDiagnostic test
Testing patches will be applied on the upper arms. Para-phenylene diamine (PPD) 1% will be applied on one upper arm. Para-toluenediamine sulfate (PTD), 2-methoxyethyl p-phenylenediamine (ME-PPD), PPD6 and PPD7 will be applied to the other upper arm.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | All participants will undergo path testing to determine skin sensitivity to certain compounds. Receives: Diagnostic Test: Sensitivity Patch Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Allergy to Study Compounds
The primary endpoint of the study is the percent of participants with a known PPD allergy who experience an allergic reaction to the study compounds PPD6 or PPD7.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start1 Apr 2021
- Primary completion13 May 2022
- Study completion13 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Bigliardi, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772482
- Sponsor's protocol ID
- DERM-2020-29233
- Status last verified
- Aug 2023
- First submitted
- 23 Feb 2021
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing of Alternatives for Dark Hair Dyes in Patients With Proven Sensitization to Para-Phenylenediamine
- ClinicalTrials.gov ID
- NCT04772482
- Acronym / sponsor ID
- DERM-2020-29233
- Conditions
- Contact Dermatitis, Allergy; Dermatitis, Dermatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 13 May 2022 (actual)
- Study completion
- 13 May 2022 (actual)
- First posted
- 26 Feb 2021 (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.
Permanent hair dyes are commonly used in over the counter direct to consumer products and within hair salons. Allergy, also known as contact dermatitis, to hair dye is a well known phenomenon. Herein, we seek to decrease the risks of allergy to hair dyes by testing a novel version of p-phenylenediamine (PPD) with less allergy potential.
Detailed description
For patients with PPD sensitizations, it is important to find alternatives for dark hair dyes. P-toluenediamine (PTD) and potentially also 2-methoxyethyl p-phenylenediamine (ME-PPD) show cross-reactivity with PPD and therefore we want to prove that our new compounds PPD-6 and PPD-7 show no or significantly reduced cross-reactions with PPD and do not induce relevant allergic reactions in patients with proven PPD sensitizations.
Our specific aims for this study are the following:
A1) To show that PPD 6 and PPD 7 have reduced or optimally no reaction in standard patch tests in patients with proven allergy to PPD A2) To compare the sensitization pattern to other possible commercially available alternatives for hair dye, such as ME-PPD and PTD A3) To evaluate and rule out any possible non-specific irritant reaction of PPD-6 and PPD-7 in these patch tests (i.e. confirm in-vitro safety profile in-vivo)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Diagnostic Test: Sensitivity Patch TestingAll participants will undergo path testing to determine skin sensitivity to certain compounds. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with sensitivity to PPD and/or PTD
Key inclusion criteria (1 listed)
- Proven Diagnosis of PPD and/or PTD sensitization (patch tests and clinically relevant eczematous reactions to hair dye)
Key exclusion criteria (6 listed)
- Use of oral immunosuppressive, anti-inflammatory and chemotherapy medications, particularly corticosteroids for at least 1 month before testing.
- Immunocompromised patient (e.g. Cancer, Diabetes mellitus, medication, Immunodeficiency, radiation therapy)
- History of acute hepatitis, chronic liver disease or end stage liver disease.
- History of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome.
- Use of illicit drugs within the past 6 months prior to study start and/or opioid use disorder.
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 |
|---|---|---|
| Sensitivity Patch TestingTesting patches will be applied on the upper arms. Para-phenylene diamine (PPD) 1% will be applied on one upper arm. Para-toluenediamine sulfate (PTD), 2-methoxyethyl p-phenylenediamine (ME-PPD), PPD6 and PPD7 will be applied to the other upper arm. | Diagnostic test | All Participants |
Primary outcome
Allergy to Study Compounds
Time frame: 4 days
The primary endpoint of the study is the percent of participants with a known PPD allergy who experience an allergic reaction to the study compounds PPD6 or PPD7.
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 25 Aug 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.
Paul Bigliardi, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contact Dermatitis and Allergy; Dermatitis, run by University of Minnesota 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 1 inclusion and 6 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 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.
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?
Allergy to Study Compounds (time frame: 4 days). 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 2023.