A STUDY TO DETERMINE THE SAFETY AND SKIN IRRITANCY TEST OF VERDURA RANGE OF PRODUCTS
- Registration Number
- CTRI/2016/10/007377
- Lead Sponsor
- Dr JRKs Siddha Research and Pharmaceuticals Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
•Availability of volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by the written informed consent form (ICF) duly signed by the volunteer.
•Healthy adult human male and non-pregnant female subjects age between 18 to 65 years.
•Subject who have no evidence of underlying disease during screening medical history and whose physical examination is performed within 28 days prior to commencement of the study.
•Subjects who do not have any previous history of adverse skin conditions and are not under any medications likely to interfere with the results.
•Willing to refrain from use of all other topical medications or antibiotics/antihistamines during the treatment period.
•Willing to avoid excessive or prolonged exposure to ultraviolet light (e.g., sunlight, tanning beds) throughout the study.
•Willing to avoid applying moisturizers, sunscreens, cosmetics and chemical peels on application sites for 24 hour prior until last follow up visit.
For Female Subjects:
•Subjects having negative Urine Pregnancy test.
•Female of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence.
•Subjects have any visible skin disease at the site of application that, in the opinion of the investigator will interfere with the skin assessments.
•People who have a job involving water contact or a job which causes perspiration. (Routine work can be done. No carrying out activities like excessive/brisk walking, exercising etc. which will lead to excessive sweating).
•Scars, hairs or tattoo on the studied area.
•Allergy or significant history of hypersensitivity or idiosyncratic Reaction to any kind of cosmetics or topical applications including Verdura or any other excipients in the particular product.
•Pregnant women or breast feeding women.
•Cardiovascular, pulmonary, hepatic, renal, hematological, Gastrointestinal, endocrinal, immunologic, dermatologic, Neurological or psychiatric disease.
•Clinically significant illness within 4 weeks before the start of the study.
•HIV I & II antibodies, anti HCV and HBsAg.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the primary skin irritancy potential of verdura cosmetic products upon topical application of occlusive single patch for a duration of 24 hrs on upper arm (Either left or right) and fore arm (Open patch test) of healthy adult human subjects.Timepoint: visit 01, 02 and 03
- Secondary Outcome Measures
Name Time Method To assess the reaction in comparison to a positive control patch tested simultaneously using Draize Scale.Timepoint: visit 01, 02 and 03