Validation of the Process of Wound Creation and Evaluation
Conditions
Brief summary
The primary objective of this study is to validate controlled methods of wound, including 1%w/v SLS, 3%w/v SLS, and 24-24 times tape stripping, on the forearms of subjects. The study aims to standardize the procedures for creating wounds and systematically evaluate the effects of these methods on various skin parameters.
Interventions
OTHERMoisturising Cream (5%)
This intervention is a moisturiging cream of concentration 5% for topical application to the respective test sites.
OTHERMoisturising Cream (10%)
This intervention is a moisturiging cream of concentration 10% for topical application to the respective test sites.
OTHERCoconut Oil
This intervention is a 100% pure coconut oil product (Parachute Pure Coconut Oil) for topical application to the respective test sites.
Sponsors
NovoBliss Research Pvt Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Proof of science/concept
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. The subject is aged between 18 and 55 years (both inclusive) at the time of informed consent. 2. The subject is a healthy adult male, or a non-pregnant, non-lactating, healthy adult female. 3. No previous history of adverse skin conditions, and not under any medication likely to interfere with the results. 4. The subject, if female, has a self-reported negative urine pregnancy test. 5. The subject is in a good general health as determined from recent medical history. 6. The subject has willingness and ability to adhere to study directions, and agrees not to use any other skin creams, lotions, serums, etc. at the application sites, except for the specified test products, and return for all specified visits. 7. The subject possesses the ability to comprehend and provide written informed consent for participation in the study.
Exclusion criteria
1. The subject is currently pregnant/lactating or is planning to become pregnant during the study period. 2. The subject has a history of allergies or specific allergic reactions upon using dermatological/cosmetic products. 3. The subject is currently enrolled in an active investigational study or has participated in an investigational study within 30 days prior to enrolment. 4. The subject suffers from any active clinically significant disease or any condition that according to the investigator's discretion warrants exclusion from the study. 5. The subject is taking or has taken a medication which, in the Investigator's judgment, makes the subject ineligible or places the subject at undue risk.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trans Epidermal Water Loss (TEWL) | Days -02, -01, 01, 02, 05, 08, 28 | Using the Tewameter® TM Hex |
| Skin hydration | Days -02, -01, 01, 02, 05, 08, 28 | Using the Corneometer® CM 825 |
| Skin surface topography | Days -02, -01, 01, 02, 05, 08, 28 | Assessment of skin smoothness, scaliness, roughness, wrinkles using the Visioscan® VC 20plus. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dermatological Assessment | Days -02, -01, 01, 02, 05, 08, 28 | Visual dermatological evaluation of the skin using the Draize scale where 0 indicates no reactions and 4 indicates severe reactions |
Countries
India
Outcome results
None listed