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NCT04274647: Draize-95
Skin Sensitization Test (Modified Draize-95 Test)
NA trial testing NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, TESTED FOR USE WITH CHEMOTHERAPY DRUGS - BLUE in Skin Sensitisation in 208 participants. Completed in 12 February 2020.
4 February 2020
Quick facts
| Lead sponsor | YTY Industry (Manjung) Sdn Bhd |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 208 |
| Start date | 10 September 2019 |
| Primary completion | 4 February 2020 |
| Estimated completion | 12 February 2020 |
| Sites | 1 location across Malaysia |
Drugs / interventions tested
- NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, TESTED FOR USE WITH CHEMOTHERAPY DRUGS - BLUE
Conditions studied
- Skin Sensitisation — all drugs for Skin Sensitisation →
Sponsor
YTY Industry (Manjung) Sdn Bhd
Who can join
Adults 18 to 65, any sex, with Skin Sensitisation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Skin Sensitization Test (Modified Draize-95) to Support a Low Dermatitis Potential Claim for a Blue Non Sterile Powder Free Nitrile Examination Gloves. 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 rubber containing medical device.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04274647
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04274647 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by YTY Industry (Manjung) Sdn Bhd
- Last refreshed: 18 February 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04274647.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing