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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-17

Study Completion Date

2024-02-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Validation of the Process of Wound Creation and Evaluation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Proof of science/concept

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Moisturising Cream A

Group Type ACTIVE_COMPARATOR

Moisturising Cream (5%)

Intervention Type OTHER

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

Moisturising Cream B

Group Type ACTIVE_COMPARATOR

Moisturising Cream (10%)

Intervention Type OTHER

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

Test Oil

Group Type PLACEBO_COMPARATOR

Coconut Oil

Intervention Type OTHER

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

Untreated

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Moisturising Cream (5%)

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

Intervention Type OTHER

Moisturising Cream (10%)

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

Intervention Type OTHER

Coconut Oil

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes