Clinical trial NCT04512274: Skin Protectant Properties of Omeza Collagen Matrix on Damaged Skin
Official title: A Single Center Study in 22 Healthy Male and Female Subjects to Investigate the Skin Protectant and Anti-Inflammatory Properties of Omeza Collagen Matrix on Damaged Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transepidermal Water Loss
Erythema
Lead sponsor: Omeza, LLC
Sponsor class: INDUSTRY
First posted: 2020-08-13
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Single-blind within subject comparison study conducted to investigate the skin protectant properties of Omeza Collagen Matrix on damaged skin

Detailed description: This study was conducted in 22 healthy subjects to determine the skin protectant and anti-inflammatory properties of the test product.

For the skin protectant assay the test article was applied to the forearm and covered with gauze for 10 minutes before assessment of irritation and TEWL readings.

An inflammatory skin response was induced by a SLS solution 24 hours prior to application of the test article. The test article was applied for 10 minutes at the site of inflammation. The test site was then graded for irritation and TEWL readings.

Eligibility criteria: Inclusion Criteria:

* Subject is a healthy male or female, aged 18 years or older.
* Subject has signed a written Informed Consent.

Exclusion Criteria:

* Pregnancy or lactation.
* Inadequate precaution or procedure to prevent pregnancy (women of child bearing potential only).
* A current skin disease of any type at the test site (e.g. eczema, psoriasis)
* Heavy alcohol consumption in the opinion of the investigator.
* A fever in the last 12 hours, prior to the initial patch application.
* Significant past medical history of hepatic, renal, cardiac, pulmonary, digestive, haematological, neurological, locomotor or psychiatric disease, which in the opinion of the Investigator would compromise the safety of the subject.
* History of malignant disease.
* Insulin dependent or non-insulin dependent diabetes.
* Concurrent medication likely to affect the response to the test articles or confuse the results of the study, i.e. routine high dosage use of antiinflammatory drugs (aspirin, ibuprofen, corticosteroids).
* Known sensitivity to the treatment solutions or their constituents including patch materials.
* Sensitisation or questionable sensitisation in a Repeat Insult Patch Test.
* Use of self-tanning lotion on the test area, one week previous to the start of the study.

Primary outcomes:
measure: Transepidermal Water Loss (TEWL)
timeFrame: 24 hours
measure: Transepidermal Water Loss (TEWL)
timeFrame: 48 hours
measure: Transepidermal Water Loss (TEWL)
timeFrame: 72 hours
measure: Transepidermal Water Loss (TEWL)
timeFrame: 96 hours
Secondary outcomes:
measure: Erythema
timeFrame: 24 hours
measure: Erythema
timeFrame: 48 hours
measure: Erythema
timeFrame: 72 hours
measure: Erythema
timeFrame: 96 hours
Other outcomes:
Locations:
city: Chelmsford
country: United Kingdom
facility: Princeton Research Corporation
state: Essex
Study officials:
affiliation: PCR Corp
name: Barrie Drewitt
role: PRINCIPAL_INVESTIGATOR
affiliation: PCR Corp
name: Andrew King
role: STUDY_DIRECTOR
References: