Skin SensitisationMDT-95NCT04402476
Skin Sensitisation (Modified Draize-95 Test)
A study testing Powder Free Polychloroprene Surgical Gloves, Sterile. Low Dermatitis Potential, tested for use with Chemotherapy drugs. in people with Skin Sensitisation, run by PT. Medisafe Technologies at 1 site in Malaysia.
Trial summary
Skin Sensitization Test (Modified Draize-95) to Support a Low Dermatitis Potential Claim for a Powder Free Polychloroprene Surgical Gloves, Sterile. To evaluate whether residual chemical additives at a level on the gloves that may induce type IV allergy to the unsensitized general user population when using… 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?
- Powder Free Polychloroprene Surgical Gloves, Sterile. Low Dermatitis Potential, tested for use with Chemotherapy drugs.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteMalaysia
- Study dates
- 23 Nov 2019to 6 Apr 2020
- 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
- The test subjects are normal volunteers who have documented informed consent and have not participated in other voluntary testing for at least 30 days.
- Age of the test subjects ranged from 18 to 65 years.
- Efforts are made to provide racial and gender diversity of the test subjects that reasonably reflects the general user population in the US
Who cannot join
- The test subjects with any visible skin disease that might be confused with skin reactions caused by the test material.
- The test subjects with any indication of existing Type I allergy to natural rubber proteins.
- The test subjects who have used corticosteroids, either systemically or topically on the potential test site, two weeks before testing.
- Test subjects who have received endogenous or exogenous immunosuppressive treatments (or prolonged sun exposure).
- All subjects who are pregnant or become pregnant during the study.
- All lactating women,
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Makmal Bioserasi & Klinikal, Healthmedic Research Sdn. Bhd.
Kuala Lumpur, Cheras, 56000
About this study
Official title: Skin Sensitisation Test (Modified Draize-95) to Support a Low Dermatitis Potential Claim
Skin Sensitization Test (Modified Draize-95) to Support a Low Dermatitis Potential Claim for a Powder Free Polychloroprene Surgical Gloves, Sterile. To evaluate whether residual chemical additives at a level on the gloves that may induce type IV allergy to the unsensitized general user population when using polychloroprene based surgical gloves
Read the detailed description
- To evaluate whether residual chemical additives at a level that may induce Type IV allergy in the unsensitized general user population are present in a finished Polychloroprene Rubber Containing Medical Device, Powder Free Polychloroprene Surgical Gloves, Sterile. (CR-SG-140-AF-WH)
- To meet requirements for claim: This product demonstrated reduced potential for sensitizing users to chemical additives as described in Guidance for Industry and FDA Staff- Medical Glove Guidance Manual. Supporting Test Data: A negative skin sensitization test (Modified Draize-95 Test) on a minimum of 200 non-sensitized human subjects.
- Conditions
- Skin Sensitisation
- Being tested
- Powder Free Polychloroprene Surgical Gloves, Sterile. Low Dermatitis Potential, tested for use with Chemotherapy drugs.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Powder Free Polychloroprene Surgical Gloves, Sterile. Low Dermatitis Potential, tested for use with Chemotherapy drugs.Device
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 | Device:
Powder Free Polychloroprene Surgical Gloves, Sterile. Low Dermatitis Potential, Tested for use with Chemotherapy Drugs.
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 Receives: Device: Powder Free Polychloroprene Surgical Gloves, Sterile. Low Dermatitis Potential, tested for use with Chemotherapy drugs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Induction Phase
Irritation scored by Erythemal Scoring Scale,
Basic Score - 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.
Measured: 24 days
Challenge Phase
Irritation scored by Erythemal Scoring Scale,
Basic Score - 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.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start23 Nov 2019
- Primary completion20 Feb 2020
- Study completion6 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Powder Free Polychloroprene Surgical Glove, Sterile. Low Dermatitis Potential, tested for use with chemotherapy drugs
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT. Medisafe Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Saadiah Sulaiman, Dermatologist, MBBCh, MMED, Study director, Makmal Bioserasi & Klinikal, Healthmedic Research Sdn. Bhd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402476
- Sponsor's protocol ID
- HMR-MDT-02-19-19-PT.MT
- Acronym
- MDT-95
- Status last verified
- Jun 2020
- First submitted
- 20 May 2020
- Last updated
- 17 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Foy V, Weinkauf R, Whittle E, Basketter DA. Ethnic variation in the skin irritation response. Contact Dermatitis. 2001 Dec;45(6):346-9. doi: 10.1034/j.1600-0536.2001.450605.x.
PubMed 11846750Kompaore F, Tsuruta H. In vivo differences between Asian, black and white in the stratum corneum barrier function. Int Arch Occup Environ Health. 1993;65(1 Suppl):S223-5. doi: 10.1007/BF00381346.
PubMed 8406931Robinson MK. Population differences in acute skin irritation responses. Race, sex, age, sensitive skin and repeat subject comparisons. Contact Dermatitis. 2002 Feb;46(2):86-93. doi: 10.1034/j.1600-0536.2002.460205.x.
PubMed 11918601
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Sensitisation Test (Modified Draize-95) to Support a Low Dermatitis Potential Claim
- ClinicalTrials.gov ID
- NCT04402476
- Acronym / sponsor ID
- MDT-95 / HMR-MDT-02-19-19-PT.MT
- Conditions
- Skin Sensitisation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- PT. Medisafe TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2019 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 6 Apr 2020 (actual)
- First posted
- 26 May 2020 (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) to Support a Low Dermatitis Potential Claim for a Powder Free Polychloroprene Surgical Gloves, Sterile. To evaluate whether residual chemical additives at a level on the gloves that may induce type IV allergy to the unsensitized general user population when using polychloroprene based surgical gloves
Detailed description
- To evaluate whether residual chemical additives at a level that may induce Type IV allergy in the unsensitized general user population are present in a finished Polychloroprene Rubber Containing Medical Device, Powder Free Polychloroprene Surgical Gloves, Sterile. (CR-SG-140-AF-WH)
- To meet requirements for claim: This product demonstrated reduced potential for sensitizing users to chemical additives as described in Guidance for Industry and FDA Staff- Medical Glove Guidance Manual. Supporting Test Data: A negative skin sensitization test (Modified Draize-95 Test) on a minimum of 200 non-sensitized human subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Powder Free Polychloroprene Surgical Glove, Sterile. Low Dermatitis Potential, tested for use with chemotherapy drugs
| Arm | Type | Receives |
|---|---|---|
| Device and Control | Experimental | Device: Powder Free Polychloroprene Surgical Gloves, Sterile. Low Dermatitis Potential, tested for use with Chemotherapy drugs.Device: Powder Free Polychloroprene Surgical Gloves, Sterile. Low Dermatitis Potential, Tested for use with Chemotherapy Drugs. 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The test subjects are normal volunteers who have documented informed consent and have not participated in other voluntary testing for at least 30 days.
- Age of the test subjects ranged from 18 to 65 years.
- Efforts are made to provide racial and gender diversity of the test subjects that reasonably reflects the general user population in the US
Key exclusion criteria (6 listed)
- The test subjects with any visible skin disease that might be confused with skin reactions caused by the test material.
- The test subjects with any indication of existing Type I allergy to natural rubber proteins.
- The test subjects who have used corticosteroids, either systemically or topically on the potential test site, two weeks before testing.
- Test subjects who have received endogenous or exogenous immunosuppressive treatments (or prolonged sun exposure).
- All subjects who are pregnant or become pregnant during the study.
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 |
|---|---|---|
| Powder Free Polychloroprene Surgical Gloves, Sterile. Low Dermatitis Potential, tested for use with Chemotherapy drugs.Approximately 2cm x 2cm square positioned to ensure that the inside portion of the test material maintained skin contact. | Device | Device and Control |
Primary outcome
Induction Phase
Time frame: 24 days
Irritation scored by Erythemal Scoring Scale, Basic Score - 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.
Challenge Phase
Time frame: 48 hours
Irritation scored by Erythemal Scoring Scale, Basic Score - 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.
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 17 Jun 2020.
- Results publication: PubMed 11846750Foy V, Weinkauf R, Whittle E, Basketter DA. Ethnic variation in the skin irritation response. Contact Dermatitis. 2001 Dec;45(6):346-9. doi: 10.1034/j.1600-0536.2001.450605.x.
- Results publication: PubMed 8406931Kompaore F, Tsuruta H. In vivo differences between Asian, black and white in the stratum corneum barrier function. Int Arch Occup Environ Health. 1993;65(1 Suppl):S223-5. doi: 10.1007/BF00381346.
- Results publication: PubMed 11918601Robinson MK. Population differences in acute skin irritation responses. Race, sex, age, sensitive skin and repeat subject comparisons. Contact Dermatitis. 2002 Feb;46(2):86-93. doi: 10.1034/j.1600-0536.2002.460205.x.
- Medical Glove Guidance ManualLink provided by the sponsor.
- Guidance for Industry and FDA Reviewers/Staff: Premarket Notification \[510(k)\] Submissions for Testing for Skin Sensitization To Chemicals In Natural Rubber Products.Link provided by the sponsor.
- 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.
Dr. Saadiah Sulaiman, Dermatologist, MBBCh, MMED study director
Makmal Bioserasi & Klinikal, Healthmedic Research Sdn. Bhd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Powder Free Polychloroprene Surgical Gloves, Sterile. Low Dermatitis Potential, tested for use with Chemotherapy drugs. in people with Skin Sensitisation, run by PT. Medisafe Technologies at 1 site in Malaysia.
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 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 17 Jun 2020. 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 Malaysia. 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?
Induction Phase (time frame: 24 days). The study lists 2 primary outcomes in all. 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 NCT04402476, which also lists 3 linked publications.
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 17 Jun 2020.