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

NCT06379516 | Completed

• 1 other identifier: NB240004-NB-V
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Validation of the Process of Wound Creation and Evaluation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Dermatological Assessment

  Days -02, -01, 01, 02, 05, 08, 28

Study Arms (4)

Moisturising Cream A

ACTIVE COMPARATOR

Other: Moisturising Cream (5%)

Moisturising Cream B

ACTIVE COMPARATOR

Other: Moisturising Cream (10%)

Test Oil

PLACEBO COMPARATOR

Other: Coconut Oil

Untreated

NO INTERVENTION

Interventions

Moisturising Cream (5%) OTHER

This intervention is a moisturiging cream of concentration 5% for topical application to the respective test sites.

Moisturising Cream A

Moisturising Cream (10%) OTHER

This intervention is a moisturiging cream of concentration 10% for topical application to the respective test sites.

Moisturising Cream B

Coconut Oil OTHER

This intervention is a 100% pure coconut oil product (Parachute Pure Coconut Oil) for topical application to the respective test sites.

Test Oil

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The subject is aged between 18 and 55 years (both inclusive) at the time of informed consent.
• The subject is a healthy adult male, or a non-pregnant, non-lactating, healthy adult female.
• No previous history of adverse skin conditions, and not under any medication likely to interfere with the results.
• The subject, if female, has a self-reported negative urine pregnancy test.
• The subject is in a good general health as determined from recent medical history.
• 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.
• The subject possesses the ability to comprehend and provide written informed consent for participation in the study.

You may not qualify if:

• The subject is currently pregnant/lactating or is planning to become pregnant during the study period.
• The subject has a history of allergies or specific allergic reactions upon using dermatological/cosmetic products.
• The subject is currently enrolled in an active investigational study or has participated in an investigational study within 30 days prior to enrolment.
• 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.

Sponsors & Collaborators

• NovoBliss Research Pvt Ltd: lead

Study Sites (1)

NovoBliss Research Pvt Ltd

Gandhinagar, Gujarat, 382421, India

Location

MeSH Terms

Interventions

Coconut Oil

Intervention Hierarchy (Ancestors)

Dietary Fats; Fats; Lipids; Plant Oils; Oils

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator - Director (Operations)

Model Details: Proof of science/concept

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 23, 2024
• Study Start: January 17, 2024
• Primary Completion: January 26, 2024
• Study Completion: February 16, 2024
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)