Process Validation in Dermatology: Assessing Wound Creation Methods and Treatment Efficacy

Not Applicable

Completed

• Conditions: Validation of the Process of Wound Creation and Evaluation
• Interventions: Other: Moisturising Cream (10%); Other: Coconut Oil; Other: Moisturising Cream (5%)

• Registration Number: NCT06379516
• Lead Sponsor: NovoBliss Research Pvt Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-17
• Primary Completion: 2024-01-26
• Study Completion: 2024-02-16
• Study First Submitted: 2024-04-18
• Study First Submitted QC: 2024-04-18
• Study First Posted: 2024-04-23
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-26
• Last Update Posted: 2024-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moisturising Cream B	Moisturising Cream (10%)	-
Test Oil	Coconut Oil	-
Moisturising Cream A	Moisturising Cream (5%)	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

NovoBliss Research Pvt Ltd; 🇮🇳 Gandhinagar, Gujarat, India