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

Comprehensive Process Validation of Dermatological Wound Creation Techniques: A Study Evaluating Methodology Standardization for Assessment of Treatment Efficacy in Controlled Skin Damage

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.

Study Overview

• Status: Completed
• Conditions: Validation of the Process of Wound Creation and Evaluation
• Intervention / Treatment: Other: Moisturising Cream (5%); Other: Moisturising Cream (10%); Other: Coconut Oil

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Gujarat
    • Gandhinagar, Gujarat, India, 382421
      • NovoBliss Research Pvt Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Untreated
Active Comparator: Moisturising Cream A	Other: Moisturising Cream (5%); This intervention is a moisturiging cream of concentration 5% for topical application to the respective test sites.
Active Comparator: Moisturising Cream B	Other: Moisturising Cream (10%); This intervention is a moisturiging cream of concentration 10% for topical application to the respective test sites.
Placebo Comparator: Test Oil	Other: Coconut Oil; This intervention is a 100% pure coconut oil product (Parachute Pure Coconut Oil) for topical application to the respective test sites.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trans Epidermal Water Loss (TEWL)	Using the Tewameter® TM Hex	Days -02, -01, 01, 02, 05, 08, 28
Skin hydration	Using the Corneometer® CM 825	Days -02, -01, 01, 02, 05, 08, 28
Skin surface topography	Assessment of skin smoothness, scaliness, roughness, wrinkles using the Visioscan® VC 20plus.	Days -02, -01, 01, 02, 05, 08, 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dermatological Assessment	Visual dermatological evaluation of the skin using the Draize scale where 0 indicates no reactions and 4 indicates severe reactions	Days -02, -01, 01, 02, 05, 08, 28

Collaborators and Investigators

• Sponsor: NovoBliss Research Pvt Ltd

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2024
• Primary Completion (Actual): January 26, 2024
• Study Completion (Actual): February 16, 2024

Study Registration Dates

• First Submitted: April 18, 2024
• First Submitted That Met QC Criteria: April 18, 2024
• First Posted (Actual): April 23, 2024

Study Record Updates

• Last Update Posted (Actual): June 27, 2024
• Last Update Submitted That Met QC Criteria: June 26, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: NB240004-NB-V

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No