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

NovoBliss Research

Status: Completed

Conditions: Validation of the Process of Wound Creation and Evaluation

Treatments: Other: Moisturising Cream (5%); Other: Coconut Oil; Other: Moisturising Cream (10%)

Study type: Interventional

Funder types: Other

Identifiers

NCT06379516

NB240004-NB-V

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 4 patient groups, including a placebo group

Moisturising Cream A

Active Comparator group

Treatment:

Other: Moisturising Cream (5%)

Moisturising Cream B

Active Comparator group

Treatment:

Other: Moisturising Cream (10%)

Test Oil

Placebo Comparator group

Treatment:

Other: Coconut Oil

Untreated

No Intervention group