Clinical trial NCT06379516: Process Validation in Dermatology: Assessing Wound Creation Methods and Treatment Efficacy
Official title: Comprehensive Process Validation of Dermatological Wound Creation Techniques: A Study Evaluating Methodology Standardization for Assessment of Treatment Efficacy in Controlled Skin Damage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Validation of the Process of Wound Creation and Evaluation
Lead sponsor: NovoBliss Research Pvt Ltd
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Proof of science/concept
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Trans Epidermal Water Loss (TEWL)
timeFrame: Days -02, -01, 01, 02, 05, 08, 28
measure: Skin hydration
timeFrame: Days -02, -01, 01, 02, 05, 08, 28
measure: Skin surface topography
timeFrame: Days -02, -01, 01, 02, 05, 08, 28
Secondary outcomes:
measure: Dermatological Assessment
timeFrame: Days -02, -01, 01, 02, 05, 08, 28
Other outcomes:
Locations:
city: Gandhinagar
country: India
facility: NovoBliss Research Pvt Ltd
state: Gujarat
Study officials:
References: