Skin SensitisationNCT03886987
Skin Sensitization Test (Modified Draize-95 Test)
A study testing Blue Non Sterile Powder Free Nitrile Examination Gloves in people with Skin Sensitisation, run by Central Medicare Sdn. Bhd. at 1 site in United States.
Trial summary
Skin Sensitization Test (Modified Draize-95 Test) to Support a Low Dermatitis Potential Claim for a Blue Non Sterile Powder Free Nitrile Examination Gloves. This study is a RIPT (Repeat Insult Patch Test) to evaluate whether residual chemical additives at the level that may induce Type IV allergy in the nonsensitized… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Sensitisation
- What is being tested?
- Blue Non Sterile Powder Free Nitrile Examination Gloves
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2018to 8 Jun 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must be aged 18 to 65 years, inclusive;
- Subjects who have not participated in other voluntary testing for at least 30 days;
- Subjects must execute an Informed Consent Form that includes a HIPAA statement; and
- Subjects must be capable of understanding and following directions.
- Female subjects must produce a negative urine pregnancy test prior to the initiation and also at the completion of the trial.
Who cannot join
- Subjects who are in ill health, as determined by the PI;
- Subjects who are taking medication, other than birth control, which could influence the purpose, integrity or outcome of the trial;
- Subjects who have used topical or systemic corticosteroids, anti-inflammatories, antihistamines or antibiotics within 2 weeks prior to trial initiation or during their participation on this trial;
- Female subjects who are pregnant as evidenced by a urine pregnancy test, planning to become pregnant or lactating during the trial;
- Subjects who have a history of adverse reactions to cosmetics, OTC drugs, or other personal care products;
- Subjects who introduce the use of any new cosmetic, toiletry or personal care products during the trial;
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- Subjects with any visible skin disease that might be confused with skin reactions caused by the test material;
- Subjects with any knowledge or indication of existing Type IV allergy (delayed hypersensitivity) to natural rubber chemical additives;
- Subjects with any indication of existing Type I allergy (immediate hypersensitivity) to natural rubber proteins;
- Subjects with a history of frequent irritation; or
- Subjects who have received endogenous or exogenous immunosuppressive treatment (or prolonged exposure to sun).
Trial locations and contacts
1 site in 1 country.
United States1 site
Consumer Product Testing Company, Inc.
Fairfield, New Jersey, 07004
About this study
Official title: Skin Sensitization Test (Modified Draize-95 Test) to Support a Low Dermatitis Potential Claim
Skin Sensitization Test (Modified Draize-95 Test) to Support a Low Dermatitis Potential Claim for a Blue Non Sterile Powder Free Nitrile Examination Gloves. This study is a RIPT (Repeat Insult Patch Test) to evaluate whether residual chemical additives at the level that may induce Type IV allergy in the nonsensitized general user population are present in a finished Blue Non Sterile Powder Free Nitrile Examination Glove.
- Conditions
- Skin Sensitisation
- Being tested
- Blue Non Sterile Powder Free Nitrile Examination Gloves
- Keywords
- Modified Draize-95 Test, Skin Sensitisation, Repeat Insult Patch Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blue Non Sterile Powder Free Nitrile Examination GlovesDevice
Approximately 2cm x 2cm square positioned to ensure that the inside portion of the test material maintained skin contact.
| Study group | Role | What they receive |
|---|---|---|
| Device and Control | Experimental | Blue Non Sterile Powder Free Nitrile Examination Gloves Dose: Approximately 2cm x 2cm square positioned to ensure that the inside portion of the test material maintained skin contact.
Positive control: 0.4% sodium lauryl sulfate (SLS) Dose: 0.2 ml
Negative control: Blank patch Dose: Not applicable Receives: Device: Blue Non Sterile Powder Free Nitrile Examination Gloves |
What is being measured
The primary outcome is the main question the study is designed to answer.
Irritation scored by Erythemal Scoring Scale
Basic Score and Description:
0 - No visible reaction. 0.5 - Doubtful or negligible erythema reaction. 1.0 - Mild or just perceptible macular erythema reaction in a speckled/follicular, patchy or confluent pattern (slight pinking).
2.0 - Moderate erythema reaction in a confluent pattern (definite redness). 3.0 - Strong or brisk erythema reaction that may spread beyond the test site.
If a subject develops a positive reaction (a score value of 1.5) to the test material or shows signs of irritation after patch applications, further patching on those individuals are stopped.
In order to qualify for the claim of a reduced sensitization potential, all 200 individuals completing the study should exhibit a score value of no more than 1.5 based on the scoring criteria.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start2 Apr 2018
- Primary completion8 Jun 2018
- Study completion8 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin SensitisationStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Blue Non Sterile Powder Free Nitrile Examination Gloves Dose: Approximately 2cm x 2cm square positioned to ensure that the inside portion of the test material maintained skin contact. Positive control: 0.4% sodium lauryl sulfate (SLS) Dose: 0.2 ml Negative control: Blank patch Dose: Not applicable
- Masking
- None (open label)
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Medicare Sdn. Bhd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Consumer Product Testing Company, Inc.
- Responsible party
- Sponsor
- Investigators
- Michael Caswell, Ph.D., CCRA, CCRC, Principal investigator, Consumer Product Testing Company, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03886987
- Sponsor's protocol ID
- CTYP01-001
- Status last verified
- Mar 2019
- First submitted
- 18 Mar 2019
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Sensitization Test (Modified Draize-95 Test) to Support a Low Dermatitis Potential Claim
- ClinicalTrials.gov ID
- NCT03886987
- Acronym / sponsor ID
- CTYP01-001
- Conditions
- Skin Sensitisation
- Keywords
- Modified Draize-95 Test, Skin Sensitisation, Repeat Insult Patch Test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Central Medicare Sdn. Bhd.Industry (pharma, biotech, devices)
- Collaborators
- Consumer Product Testing Company, Inc.
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 8 Jun 2018 (actual)
- Study completion
- 8 Jun 2018 (actual)
- First posted
- 22 Mar 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.
Skin Sensitization Test (Modified Draize-95 Test) to Support a Low Dermatitis Potential Claim for a Blue Non Sterile Powder Free Nitrile Examination Gloves. This study is a RIPT (Repeat Insult Patch Test) to evaluate whether residual chemical additives at the level that may induce Type IV allergy in the nonsensitized general user population are present in a finished Blue Non Sterile Powder Free Nitrile Examination Glove.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Blue Non Sterile Powder Free Nitrile Examination Gloves Dose: Approximately 2cm x 2cm square positioned to ensure that the inside portion of the test material maintained skin contact. Positive control: 0.4% sodium lauryl sulfate (SLS) Dose: 0.2 ml Negative control: Blank patch Dose: Not applicable
| Arm | Type | Receives |
|---|---|---|
| Device and Control | Experimental | Device: Blue Non Sterile Powder Free Nitrile Examination GlovesBlue Non Sterile Powder Free Nitrile Examination Gloves Dose: Approximately 2cm x 2cm square positioned to ensure that the inside portion of the test material maintained skin contact. Positive control: 0.4% sodium lauryl sulfate (SLS) Dose: 0.2 ml Negative control: Blank patch Dose: Not applicable |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects must be aged 18 to 65 years, inclusive;
- Subjects who have not participated in other voluntary testing for at least 30 days;
- Subjects must execute an Informed Consent Form that includes a HIPAA statement; and
- Subjects must be capable of understanding and following directions.
- Female subjects must produce a negative urine pregnancy test prior to the initiation and also at the completion of the trial.
Key exclusion criteria (11 listed)
- Subjects who are in ill health, as determined by the PI;
- Subjects who are taking medication, other than birth control, which could influence the purpose, integrity or outcome of the trial;
- Subjects who have used topical or systemic corticosteroids, anti-inflammatories, antihistamines or antibiotics within 2 weeks prior to trial initiation or during their participation on this trial;
- Female subjects who are pregnant as evidenced by a urine pregnancy test, planning to become pregnant or lactating during the trial;
- Subjects who have a history of adverse reactions to cosmetics, OTC drugs, or other personal care products;
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 |
|---|---|---|
| Blue Non Sterile Powder Free Nitrile Examination GlovesApproximately 2cm x 2cm square positioned to ensure that the inside portion of the test material maintained skin contact. | Device | Device and Control |
Primary outcome
Irritation scored by Erythemal Scoring Scale
Time frame: 8 weeks
Basic Score and Description: 0 - No visible reaction. 0.5 - Doubtful or negligible erythema reaction. 1.0 - Mild or just perceptible macular erythema reaction in a speckled/follicular, patchy or confluent pattern (slight pinking). 2.0 - Moderate erythema reaction in a confluent pattern (definite redness). 3.0 - Strong or brisk erythema reaction that may spread beyond the test site. If a subject develops a positive reaction (a score value of 1.5) to the test material or shows signs of irritation after patch applications, further patching on those individuals are stopped. In order to qualify for the claim of a reduced sensitization potential, all 200 individuals completing the study should exhibit a score value of no more than 1.5 based on the scoring criteria.
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 22 Mar 2019.
- Individual participant dataSharing planned: No
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.
Michael Caswell, Ph.D., CCRA, CCRC principal investigator
Consumer Product Testing Company, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blue Non Sterile Powder Free Nitrile Examination Gloves in people with Skin Sensitisation, run by Central Medicare Sdn. Bhd. 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 5 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 22 Mar 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?
Irritation scored by Erythemal Scoring Scale (time frame: 8 weeks). 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 22 Mar 2019; AzTrials last refreshed its copy on 27 Oct 2026.