Skin Irritation Test of KETOSOFT Shampoo Containing Salicylic Acid and Ketoconazole Medicated in Healthy Human Volunteers
Not Applicable
Completed
- Registration Number
- CTRI/2019/07/020122
- Lead Sponsor
- Aurochem Laboratories Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
Signed informed consent will be obtained.
Volunteers without signs of skin irritation/disease/disorders/symptoms or blemishes on test sites (e.g. erythema, dryness, roughness, scaling, scars, moles, sunburn).
Volunteers without a significant abnormality, as judged by the Principal Investigator.
Exclusion Criteria
History of alcohol or drug abuse.
History of allergic reaction to any medications.
History or presence of any skin disease.
Any disease that could in any way confound assessment of the test sites.
Known or suspected hypersensitivity to any component of Ketosoft shampoo.
Known or suspected hepatic, renal or cardiac disorders.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the safety of the test material by closed patch test in healthy volunteers will be determined.Timepoint: The trial will consist of 3 periods which are described below. <br/ ><br>Screening period: Prior to investigational product application on Day 1, a screening period will be required to ensure the volunteers are suitable to participate. <br/ ><br> Testing period: The testing period will be from Day -1 until Day 8. Skin will be assessed, 24 hours after removal of patches. <br/ ><br>Follow-up period: Volunteers will be followed up on Day 8 to assess AEâ??s if any and post-application hematology analysis will be done.
- Secondary Outcome Measures
Name Time Method It will help to determine the irritant and/ or corrosive effects on the skin, if any.Timepoint: The trial will consist of 3 periods which are described below. <br/ ><br>Screening period: Prior to investigational product application on Day 1, a screening period will be required to ensure the volunteers are suitable to participate. <br/ ><br> Testing period: The testing period will be from Day -1 until Day 8. Skin will be assessed, 24 hours after removal of patches. <br/ ><br>Follow-up period: Volunteers will be followed up on Day 8 to assess AEâ??s if any and post-application hematology analysis will be done.