--- title: Skin Sensitisation (Modified Draize-95 Test) nct_id: NCT04402476 overall_status: COMPLETED phase: NA sponsor: PT. Medisafe Technologies study_type: INTERVENTIONAL primary_condition: Skin Sensitisation countries: Malaysia canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04402476.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04402476" ct_last_update_post_date: 2020-06-17 last_seen_at: "2026-05-12T06:49:30.785Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Skin Sensitisation (Modified Draize-95 Test) **Official Title:** Skin Sensitisation Test (Modified Draize-95) to Support a Low Dermatitis Potential Claim **NCT ID:** [NCT04402476](https://clinicaltrials.gov/study/NCT04402476) ## Key Facts - **Status:** COMPLETED - **Phase:** NA - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 208 - **Lead Sponsor:** PT. Medisafe Technologies - **Conditions:** Skin Sensitisation - **Start Date:** 2019-11-23 - **Completion Date:** 2020-04-06 - **CT.gov Last Update:** 2020-06-17 ## Brief 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 polychloroprene based surgical gloves ## Detailed Description 1. 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) 2. 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. ## Eligibility - **Minimum age:** 18 Years - **Maximum age:** 65 Years - **Sex:** ALL - **Healthy Volunteers:** Yes ``` Inclusion Criteria: * 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 Exclusion Criteria: * 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, ``` ## Arms - **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 ## Interventions - **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. ## Primary Outcomes - **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. ## Locations (1) - Makmal Bioserasi & Klinikal, Healthmedic Research Sdn. Bhd., Kuala Lumpur, Cheras, Malaysia ## Recent Field Changes (last 30 days) - `status.completionDate` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.makmal bioserasi & klinikal, healthmedic research sdn. bhd.|kuala lumpur|cheras|malaysia` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT04402476.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT04402476* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*