Irritant Contact DermatitisNCT03483025
Prospective Single Center Randomized Double Blind Controlled Tolerability Trial of Six Hair Cleansing Conditioners
A study testing Skin Testing of Hair cleansing products in people with Irritant Contact Dermatitis, run by HealthPartners Institute at 1 site in United States.
Trial summary
Hair cleansing product tolerability study Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Irritant Contact Dermatitis
- What is being tested?
- Skin Testing of Hair cleansing products
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2018to 14 Dec 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed and witnessed written informed consent
- Willingness and ability to comply with the study protocol
- For women of child-bearing potential, negative urine pregnancy test at enrollment
Who cannot join
- The presence of an overt bacterial, viral or fungal infection of the arms
- The presence of any skin condition on the arms that, in the opinion of the investigator, could interfere with study assessments.
- History of bullous skin disorders, psoriasis, ichthyosis, and/or any other chronic skin condition which could result in skin barrier dysfunction (other than atopic dermatitis).
- Treatment with systemic immunosuppressive drugs within 2 weeks of enrollment.
- Treatment with topical antibacterial, antimycotic, or immunosuppressive medications (including topical corticosteroids) on the forearms within 2 weeks of enrollment.
- Use of over-the-counter moisturizers to the forearms in the 3 days prior to protocol commencement.
Show all 11Show fewer
- Menstruating females of childbearing potential who are not willing to use a medically accepted method of contraception, during the study and up to 4 weeks after the end of study. Medically approved contraception may, at the discretion of the investigator, include abstinence.
- Women who are breastfeeding
- Patients with a severe medical condition(s) which, in the view of the investigator, prohibits participation in the study
- Use of any other investigational agent in the 30 days prior to study commencement
- Known allergy to the study products or ingredients
Trial locations and contacts
1 site in 1 country.
United States1 site
Park Nicollet Contact Dermatitis Clinic
Minneapolis, Minnesota, 55450
About this study
Hair cleansing product tolerability study
Read the detailed description
Study Aim: The objective of this study is to evaluate the tolerability of daily use of f hair cleansing products.
Background/Study Rational/Significance: There have been consumer reports of irritancy and hair loss with use of Wen cleansing conditioner. A recent study of 142 patients found no increase in hair loss when used in normal subjects, however skin assessments for tolerability were not evaluated.
Methodology: This double-blind, randomized, controlled clinical trial will evaluate the tolerability of six hair cleansing products including Wen cleansing conditioner using two standard clinical and research methods, Repeat Open Application Tests (ROAT) (a test for irritancy) and Semi-Open Patch Tests (a test for allergenicity). For the ROAT, participants will apply the hair cleansing products to 6 separate locations on the forearm using a standardized, protocol and scored using a 10-point scale. Application site of each cleansing product will be randomized. Exposure time will be increased in a step-wise fashion over 5 weeks. Participants and investigators will be blinded to location of products. The primary outcome is intolerance; intolerance will be defined as 1) ROAT skin component scoring >6 (of 10 maximum) or 2) ROAT global score of >4 (of 5 maximum). If intolerance to a specific product is reached, the ROAT for that product will be discontinued. . Clinical assessments (global scoring and component scoring) will be performed at 0, 2, and 4 and 5 weeks. Primary outcomes will be measured at 5 weeks. Allergenicity is a secondary outcome and will be assessed with semi-open patch tests to the 6 hair cleansing products performed at week 4 and read at week 5
Setting/ patients: Single center study of 200 patients. To represent a broad spectrum of skin barrier function, recruitment will target enrollment of 150 individuals with a no history of childhood eczema (non-atopic) and 50 individuals with a history of childhood eczema (atopic).
Population: Men and women over the age of 18 years old.
- Conditions
- Irritant Contact Dermatitis
- Being tested
- Skin Testing of Hair cleansing products
- Medical subject headings
- Dermatitis, Irritant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin Testing of Hair cleansing productsOther
6 different commercially available shampoos
| Study group | Role | What they receive |
|---|---|---|
| Hair Cleansing product 1 | Other | Skin Testing of Hair cleansing products all pts will test 6 hair cleansing products, but site of testing will be randomized and blinded Receives: Other: Skin Testing of Hair cleansing products |
| Hair cleansing product 2 | Other | Skin Testing of Hair cleansing products all pts will test 6 hair cleansing products, but site of testing will be randomized and blinded Receives: Other: Skin Testing of Hair cleansing products |
| Hair cleansing product 3 | Other | Skin Testing of Hair cleansing products all pts will test 6 hair cleansing products, but site of testing will be randomized and blinded Receives: Other: Skin Testing of Hair cleansing products |
| Hair cleansing product 4 | Other | Skin Testing of Hair cleansing products all pts will test 6 hair cleansing products, but site of testing will be randomized and blinded Receives: Other: Skin Testing of Hair cleansing products |
| Hair cleansing product 5 | Other | Skin Testing of Hair cleansing products all pts will test 6 hair cleansing products, but site of testing will be randomized and blinded Receives: Other: Skin Testing of Hair cleansing products |
| Hair cleansing product 6 | Other | Skin Testing of Hair cleansing products all pts will test 6 hair cleansing products, but site of testing will be randomized and blinded Receives: Other: Skin Testing of Hair cleansing products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeat Open Application Test
intolerance will be defined as 1) ROAT skin component scoring >6 (of 10 maximum) or 2) ROAT global score of >4 (of 5 maximum).
Measured: 5 wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start4 Apr 2018
- Primary completion14 Dec 2018
- Study completion14 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritant 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- randomized, double-blind, controlled
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- erin warshaw, MD, Principal investigator, HealthPartners Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483025
- Sponsor's protocol ID
- A17-335
- Status last verified
- Apr 2018
- First submitted
- 20 Mar 2018
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Warshaw EM, Schlarbaum JP, Liou YL, Kimyon RS, Zhang AJ, Nikle AB, Monnot AD, Hylwa SA. Tolerability of hair cleansing conditioners: a double-blind randomized, controlled trial designed to evaluate consumer complaints to the U.S. Food and Drug Administration. Cutan Ocul Toxicol. 2020 Jun;39(2):89-96. doi: 10.1080/15569527.2020.1722154. Epub 2020 Mar 2.
PubMed 32122177
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Single Center Randomized Double Blind Controlled Tolerability Trial of Six Hair Cleansing Conditioners
- ClinicalTrials.gov ID
- NCT03483025
- Acronym / sponsor ID
- A17-335
- Conditions
- Irritant Contact Dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 14 Dec 2018 (actual)
- Study completion
- 14 Dec 2018 (actual)
- First posted
- 29 Mar 2018 (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.
Hair cleansing product tolerability study
Detailed description
Study Aim: The objective of this study is to evaluate the tolerability of daily use of f hair cleansing products.
Background/Study Rational/Significance: There have been consumer reports of irritancy and hair loss with use of Wen cleansing conditioner. A recent study of 142 patients found no increase in hair loss when used in normal subjects, however skin assessments for tolerability were not evaluated.
Methodology: This double-blind, randomized, controlled clinical trial will evaluate the tolerability of six hair cleansing products including Wen cleansing conditioner using two standard clinical and research methods, Repeat Open Application Tests (ROAT) (a test for irritancy) and Semi-Open Patch Tests (a test for allergenicity). For the ROAT, participants will apply the hair cleansing products to 6 separate locations on the forearm using a standardized, protocol and scored using a 10-point scale. Application site of each cleansing product will be randomized. Exposure time will be increased in a step-wise fashion over 5 weeks. Participants and investigators will be blinded to location of products. The primary outcome is intolerance; intolerance will be defined as 1) ROAT skin component scoring >6 (of 10 maximum) or 2) ROAT global score of >4 (of 5 maximum). If intolerance to a specific product is reached, the ROAT for that product will be discontinued. . Clinical assessments (global scoring and component scoring) will be performed at 0, 2, and 4 and 5 weeks. Primary outcomes will be measured at 5 weeks. Allergenicity is a secondary outcome and will be assessed with semi-open patch tests to the 6 hair cleansing products performed at week 4 and read at week 5
Setting/ patients: Single center study of 200 patients. To represent a broad spectrum of skin barrier function, recruitment will target enrollment of 150 individuals with a no history of childhood eczema (non-atopic) and 50 individuals with a history of childhood eczema (atopic).
Population: Men and women over the age of 18 years old.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- randomized, double-blind, controlled
| Arm | Type | Receives |
|---|---|---|
| Hair Cleansing product 1 | Other | Other: Skin Testing of Hair cleansing productsSkin Testing of Hair cleansing products all pts will test 6 hair cleansing products, but site of testing will be randomized and blinded |
| Hair cleansing product 2 | Other | Other: Skin Testing of Hair cleansing productsSkin Testing of Hair cleansing products all pts will test 6 hair cleansing products, but site of testing will be randomized and blinded |
| Hair cleansing product 3 | Other | Other: Skin Testing of Hair cleansing productsSkin Testing of Hair cleansing products all pts will test 6 hair cleansing products, but site of testing will be randomized and blinded |
| Hair cleansing product 4 | Other | Other: Skin Testing of Hair cleansing productsSkin Testing of Hair cleansing products all pts will test 6 hair cleansing products, but site of testing will be randomized and blinded |
| Hair cleansing product 5 | Other | Other: Skin Testing of Hair cleansing productsSkin Testing of Hair cleansing products all pts will test 6 hair cleansing products, but site of testing will be randomized and blinded |
| Hair cleansing product 6 | Other | Other: Skin Testing of Hair cleansing productsSkin Testing of Hair cleansing products all pts will test 6 hair cleansing products, but site of testing will be randomized and blinded |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed and witnessed written informed consent
- Willingness and ability to comply with the study protocol
- For women of child-bearing potential, negative urine pregnancy test at enrollment
Key exclusion criteria (11 listed)
- The presence of an overt bacterial, viral or fungal infection of the arms
- The presence of any skin condition on the arms that, in the opinion of the investigator, could interfere with study assessments.
- History of bullous skin disorders, psoriasis, ichthyosis, and/or any other chronic skin condition which could result in skin barrier dysfunction (other than atopic dermatitis).
- Treatment with systemic immunosuppressive drugs within 2 weeks of enrollment.
- Treatment with topical antibacterial, antimycotic, or immunosuppressive medications (including topical corticosteroids) on the forearms within 2 weeks of enrollment.
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 |
|---|---|---|
| Skin Testing of Hair cleansing products6 different commercially available shampoos | Other | Hair Cleansing product 1, Hair cleansing product 2, Hair cleansing product 3, Hair cleansing product 4, Hair cleansing product 5, Hair cleansing product 6 |
Primary outcome
Repeat Open Application Test
Time frame: 5 wks
intolerance will be defined as 1) ROAT skin component scoring >6 (of 10 maximum) or 2) ROAT global score of >4 (of 5 maximum).
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 Feb 2019.
- Derived from this study: PubMed 32122177Warshaw EM, Schlarbaum JP, Liou YL, Kimyon RS, Zhang AJ, Nikle AB, Monnot AD, Hylwa SA. Tolerability of hair cleansing conditioners: a double-blind randomized, controlled trial designed to evaluate consumer complaints to the U.S. Food and Drug Administration. Cutan Ocul Toxicol. 2020 Jun;39(2):89-96. doi: 10.1080/15569527.2020.1722154. Epub 2020 Mar 2.
- Individual participant dataSharing planned: No
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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.
erin warshaw, MD principal investigator
HealthPartners Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin Testing of Hair cleansing products in people with Irritant Contact Dermatitis, run by HealthPartners Institute 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 3 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: finished, as of the sponsor's last update on 25 Feb 2019. 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?
Repeat Open Application Test (time frame: 5 wks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03483025, which also lists 1 linked publication.
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 Feb 2019.