NCT04402476|Completed
Skin Sensitisation (Modified Draize-95 Test)
MDT-95
Skin Sensitisation Test (Modified Draize-95) to Support a Low Dermatitis Potential Claim
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MDT-95
Skin Sensitisation Test (Modified Draize-95) to Support a Low Dermatitis Potential Claim
Sponsor study identifier
interventional
208
1 country
1
Study Start
November 23, 2019
Actual (reported)Primary Completion
February 20, 2020
Actual (reported)Study Completion
April 6, 2020
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 6, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 23, 2019
Actual (reported)February 20, 2020
Actual (reported)April 6, 2020
Actual (reported)May 20, 2020
Actual (reported)May 26, 2020
Actual (reported)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.
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.
48 hours
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
Approximately 2cm x 2cm square positioned to ensure that the inside portion of the test material maintained skin contact.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Makmal Bioserasi & Klinikal, Healthmedic Research Sdn. Bhd.
Kuala Lumpur, Cheras, 56000, Malaysia
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.
Kompaore 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.
Robinson 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.
Dr. Saadiah Sulaiman, Dermatologist, MBBCh, MMED
Makmal Bioserasi & Klinikal, Healthmedic Research Sdn. Bhd.
208 participants (actual enrollment reported by the registry).
First Submitted
May 20, 2020
First Posted
May 26, 2020
Study Start
November 23, 2019
Actual (reported)Study Comparing iNPWT Dressing and Devices Affect on Bioburden Levels and Skin Condition After Seven Days
Contact the study team to confirm eligibility.
Primary Completion
February 20, 2020
Actual (reported)Study Completion
April 6, 2020
Actual (reported)Last Updated
June 17, 2020
Record last verified: 2020-06
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Source: ClinicalTrials.gov.
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