None listed
Conditions
Interventions
Intervention1: intervention product-Seriderm(TM) Non-adherent absorbent wound dressing device. Positive control-Histamine solution Negative control-Normal saline solution.: This study aims to evaluate
Sponsors
Serigen Mediproducts Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy adult, human volunteers, of either sex, aged above 18 years. 2.Completed written informed consent and receive a copy of their executed ICD. 3. Volunteers must be capable of understanding. 4. Body mass index of ? 18.50 kg/m2 and ? 30.00 kg/m2 (inclusive of both) and weight ? 50 kgs for male subjects and ? 45 kgs for female subjects. 5. Volunteers with no known allergic reactions 6. Volunteers willing to give written informed consent and adhere to all the requirements of the protocol
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation 2. Inadequate or non-existent contraception (women of child bearing potential only). 3. A current skin disease of any type apart from mild facial acne (e.g. eczema, psoriasis). 4. Volunteers known, or thought to be hypersensitivity to test product. 5. Current use or history of repeated use of recreational drugs. 6. Significant past medical history of hepatic, renal, cardiac, pulmonary, digestive, hematological, neurological, locomotor or psychiatric disease. 7.0Participation in a Human Repeat Insult Patch Test (HRIPT), Skin Prick Test (SPT) or follow up work within the last month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the allergic reactions of Seriderm™ Non-adherent absorbent wound dressing device by skin prick test.Timepoint: The outcome will be assessed at 15 minutes, 6 hours & 24 hours after skin prick | — |
Secondary
| Measure | Time frame |
|---|---|
| Monitoring of adverse events and change in vital signs.Timepoint: Through out the study. | — |
Countries
India
Contacts
Public ContactDr D Tejo Swaroop Kumar
Noah Therapeutics Private Limited
Outcome results
None listed