Skin irritancy potential of detergents in healthy human volunteers
- Registration Number
- CTRI/2024/04/065908
- Lead Sponsor
- nilever Industries Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Adult Female volunteers between 18 and 45 years.
2.Photo type II to V (which includes sensitive skin type)
3.Having apparently healthy skin on test area.
4.No H/O any allergies to any food/ food ingredients.
5.For whom the investigator considers that the compliance will be correct.
6.Cooperating, informed of the need and duration of the examinations and ready to comply with protocol procedures.
7.Having signed a Consent Form.
8.Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study.
9.Willingness to avoid excessive water contact (for example swimming) or activity which causes excessive sweating (that is exercise, sauna…), during the course of the study.
10.Should avoid using any type of moisturizing cream or soaps or oil or face wash during the study (14 days).
11.Should be able to read and write (in English, Hindi or local language).
12.Having valid proof of identity and age.
1.Pregnant/nursing mothers
2.Scars, excessive terminal hair or tattoo on the studied area.
3.Dermatological infection/pathology on the level of studied area.
4.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye).
5.Any allergies to any food/ food ingredients
6.Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures.
7.Chronic illness which may influence the outcome of the study.
8.Using any type of Moisturizing cream or soaps or face wash or oil.
9.Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month).
10.Subject in an exclusion period or participating in another food, cosmetic or therapeutic trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Comparison of Skin reaction scores (dryness and scales) between comparator and test products. <br/ ><br>2.Comparison of Videoscopy between comparator and test products. <br/ ><br>3.Comparison of TEWL between comparator and test products. <br/ ><br>4.Comparison of Hydration level between comparator and test products. <br/ ><br>Timepoint: Day 0 to Day 7
- Secondary Outcome Measures
Name Time Method Safety of the product based on investigator assessmentTimepoint: Day 0 to Day 7