To check irritation potential of the given samples
Phase 2
Completed
- Conditions
- SKIN PATCH TEST
- Registration Number
- CTRI/2012/11/003098
- Lead Sponsor
- ITC R and D CENTRE
- Brief Summary
Skin Irritation Test:
Irritants are substances that damage the skin. The damage will depend upon the nature, concentration and duration of exposure. Irritation is manifested as inflammatory responses such as erythema (redness), Oedema (swelling), and vesiculation and finally to an intense suppurate reaction without the involvement of the immune system. The irritation potential of a substance can be assessed by human patch test.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- 1.Is a female/ male in generally good health?
- 2.Is between the ages of 18 and 50 years?
- 3.Has not participated in a similar clinical investigation in the past four weeks?
- 4.Is willing to give a written informed consent and come for regular observation?
Exclusion Criteria
- A known history or present condition of allergic response to any cosmetic products.
- Skin disease (e.g. psoriasis, atopic dermatitis or other cutaneous manifestations on the scalp), which would interfere with the test readings.
- Medications (e.g. steroids or antihistamines), which would compromise the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method irritation potential first observation will be made at 30 minutes of patch removal (0 hr. observation). The further observations will be at 24 hrs and 1 week of patch removal.
- Secondary Outcome Measures
Name Time Method Investigational products to be tested for irritancy test On each subject’s back one patch of each investigational product will be applied on Day 1. This will be 9 days study. For all the products and positive control the subjects will be assessed by the study dermatologist on Day 1 (Day of patch application), Day 2 (0 hrs. of patch removal i.e. 24 hrs. of patch application), Day 3 (24 hrs. of patch removal) and Day 9 (1 week after patch removal).
Trial Locations
- Locations (1)
The KETs Scientific research centre, Cosmetology division
🇮🇳(Suburban), MAHARASHTRA, India
The KETs Scientific research centre, Cosmetology division🇮🇳(Suburban), MAHARASHTRA, IndiaMsMayuri JaitaplPrincipal investigator02225639644mayuri@kelkarcosmetology.com